A Study of Tirzepatide Compared with Intensified Conventional Care in Adult Participants with Type 2 Diabetes (SURPASS-EARLY)

2022-501073-40-00 Protocol I8F-MC-GPHE Therapeutic use (Phase IV) Authorised, recruiting

Start 27 Jan 2023 · Status Authorised, recruiting · 5 EU/EEA countries · 31 sites · Protocol I8F-MC-GPHE

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruiting
Participants planned 781
Countries 5
Sites 31

Type 2 Diabetes

To demonstrate that tirzepatide is non-inferior to intensified conventional care in HbA1c change from baseline to Week 104 in participants with T2D

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Hormonal diseases [C19]
Trial duration
27 Jan 2023 → ongoing
Decision date (initial)
2022-12-02
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2022-501073-40-00
ClinicalTrials.gov
NCT05433584

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To demonstrate that tirzepatide is non-inferior to intensified conventional care in HbA1c change from baseline to Week 104 in participants with T2D

Conditions and MedDRA coding

Type 2 Diabetes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
  2. Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.
  3. Have been on a stable treatment of metformin only at least 90 days preceding baseline with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or <1500 mg/day in case of intolerance of full therapeutic dose.

Exclusion criteria 8

  1. Have type 1 diabetes mellitus
  2. Have a history of chronic or acute pancreatitis any time prior to study entry
  3. Have a history of proliferative diabetic retinopathy, diabetic macular edema, or no proliferative diabetic retinopathy requiring immediate or urgent treatment
  4. Are at high risk for cardiovascular disease (CVD) in the investigator’s opinion or have a history of any of these CV conditions prior to Visit 1 myocardial infarction, percutaneous coronary revascularization procedure, carotid stenting or surgical revascularization, nontraumatic amputation, peripheral vascular procedure (e.g., stenting or surgical revascularization), cerebrovascular accident (stroke), or congestive heart failure
  5. Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
  6. Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
  7. Have an eGFR <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
  8. Have been treated with any injectable GLP-1 receptor agonists and insulin prior to screening. Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from Baseline in Hemoglobin A1c (HbA1c)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Tirzepatide

PRD11922453 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS USE
Max daily dose
15 mg milligram(s)
Max total dose
15 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922454 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS USE
Max daily dose
15 mg milligram(s)
Max total dose
15 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922455 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS USE
Max daily dose
15 mg milligram(s)
Max total dose
15 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922457 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS USE
Max daily dose
15 mg milligram(s)
Max total dose
15 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922458 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS USE
Max daily dose
15 mg milligram(s)
Max total dose
15 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922456 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SUBCUTANEOUS USE
Max daily dose
15 mg milligram(s)
Max total dose
15 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Auxiliary 35

Liraglutide

SUB25238 · Substance

Active substance
Liraglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
3 mg milligram(s)
Max total dose
3 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Albiglutide

SUB120850 · Substance

Active substance
Albiglutide
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

A10BX · Product

Pharmaceutical form
PHF00165MIG
Route of administration
ORAL USE
Max daily dose
540 mg milligram(s)
Max total dose
540 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
A10BX — OTHER ORAL BLOOD GLUCOSE LOWERING DRUGS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Albiglutide

SUB120850 · Substance

Active substance
Albiglutide
Pharmaceutical form
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Route of administration
INJECTION
Max daily dose
50 mg milligram(s)
Max total dose
50 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Exenatide

SUB21818 · Substance

Active substance
Exenatide
Pharmaceutical form
SUSPENSION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dulaglutide

SUB130484 · Substance

Active substance
Dulaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
4.5 mg milligram(s)
Max total dose
4.5 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Exenatide

SUB21818 · Substance

Active substance
Exenatide
Pharmaceutical form
POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sitagliptin

SUB25227 · Substance

Active substance
Sitagliptin
Pharmaceutical form
TABLETS
Route of administration
ORAL USE
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Alogliptin

SUB32564 · Substance

Active substance
Alogliptin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
25 mg milligram(s)
Max total dose
25 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
14 mg milligram(s)
Max total dose
14 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

A10BB · Product

Pharmaceutical form
PHF00245MIG
Route of administration
ORAL USE
Max daily dose
320 mg milligram(s)
Max total dose
320 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
A10BB — SULFONAMIDES, UREA DERIVATIVES
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sitagliptin

SUB25227 · Substance

Active substance
Sitagliptin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Metformin

SCP135808 · ATC

Active substance
Metformin
Substance synonyms
DIMETHYLDIGUANIDE
Route of administration
ORAL USE
Max daily dose
3000 mg milligram(s)
Max total dose
3000 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
A10BA02 — METFORMIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Saxagliptin

SUB25220 · Substance

Active substance
Saxagliptin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vildagliptin

SUB25199 · Substance

Active substance
Vildagliptin
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Alogliptin

SUB32564 · Substance

Active substance
Alogliptin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
25 mg milligram(s)
Max total dose
25 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Linagliptin

SUB31340 · Substance

Active substance
Linagliptin
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sitagliptin

SUB25227 · Substance

Active substance
Sitagliptin
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
100 mg milligram(s)
Max total dose
100 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dulaglutide

SUB130484 · Substance

Active substance
Dulaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
4.5 mg milligram(s)
Max total dose
4.5 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lixisenatide

SUB32251 · Substance

Active substance
Lixisenatide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
20 µg microgram(s)
Max total dose
20 µg microgram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2 mg milligram(s)
Max total dose
2 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
14 mg milligram(s)
Max total dose
14 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Metformin Hydrochloride

SCP186537 · ATC

Active substance
Metformin Hydrochloride
Substance synonyms
BMS207150, 2-(N,N-DIMETHYLCARBAMIMIDOYL)GUANIDINE HYDROCHLORIDE, 3-(DIAMINOMETHYLIDENE)-1,1-DIMETHYL-GUANIDINE HYDROCHLORIDE
Route of administration
ORAL USE
Max daily dose
3000 mg milligram(s)
Max total dose
3000 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
A10BD02 — METFORMIN AND SULFONAMIDES
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Saxagliptin

SUB25220 · Substance

Active substance
Saxagliptin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Exenatide

SUB21818 · Substance

Active substance
Exenatide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
20 µg microgram(s)
Max total dose
20 µg microgram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

A10A · Product

Pharmaceutical form
-
Route of administration
SOLUTION FOR INJECTION
Max daily dose
5 ml millilitre(s)
Max total dose
5 ml millilitre(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
A10A — INSULINS AND ANALOGUES
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Semaglutide

SUB32188 · Substance

Active substance
Semaglutide
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
14 mg milligram(s)
Max total dose
14 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

A10BF · Product

Pharmaceutical form
PHF00245MIG
Route of administration
ORAL USE
Max daily dose
25 mg milligram(s)
Max total dose
25 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
A10BF — ALPHA GLUCOSIDASE INHIBITORS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pioglitazone

SCP129581 · ATC

Active substance
Pioglitazone
Route of administration
ORAL USE
Max daily dose
45 mg milligram(s)
Max total dose
45 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
A10BG03 — PIOGLITAZONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dulaglutide

SUB130484 · Substance

Active substance
Dulaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
4.5 mg milligram(s)
Max total dose
4.5 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dulaglutide

SUB130484 · Substance

Active substance
Dulaglutide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
4.5 mg milligram(s)
Max total dose
4.5 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Alogliptin

SUB32564 · Substance

Active substance
Alogliptin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
25 mg milligram(s)
Max total dose
25 mg milligram(s)
Max treatment duration
208 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly Cork Limited
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly Cork Limited
Contact name
Lilly Clinical Trials information desk

Third parties 7

OrganisationCity, countryDuties
Bioagilytix Labs
ORG-100013030
 Durham, United States Laboratory analysis
Quintiles Laboratories Europe
ORG-100017355
 Livingston, United Kingdom Laboratory analysis
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Cleveland Clinic
ORG-100028017
 Cleveland, United States Other
Q2 Solutions LLC
ORG-100017000
 Ithaca, United States Laboratory analysis
Iqvia Inc.
ORG-100010622
 Durham, United States On site monitoring
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Interactive response technologies (IRT)

Locations

5 EU/EEA countries · 31 investigational sites

By country

CountryMS statusPlanned subjectsSites
Czechia Not authorised 59 5
Germany Ongoing, recruitment ended 37 6
Italy Ongoing, recruitment ended 32 8
Romania Ongoing, recruitment ended 62 7
Slovakia Ongoing, recruitment ended 40 5
Rest of world
Mexico, United Kingdom, Canada, United States, Israel, Argentina
 — 551 —

Investigational sites

Czechia

5 sites · Not authorised
Diabet2 s.r.o.
N/A, Lucni 1611, 263 01, Dobris
Restrial s.r.o.
N/A, V Sadech 1081 4a, 160 00, Prague 6
Milan Kvapil s.r.o.
N/A, Lucni 1611, 263 01, Dobris
MUDr. Tomas Edelsberger
N/A, Ricni Okruh 2340/28, 794 01, Pod Bezrucovym Vrchem
Milan Kvapil s.r.o.
N/A, Lucni 1611, 263 01, Dobris

Germany

6 sites · Ongoing, recruitment ended
MVZ Diamedicum Bad Mergentheim GmbH
Diabetes/Cardiovascular Disease, Theodor-Klotzbücher-Straße 12, 97980, Bad Mergentheim
Red Institut Fur Medizinische Forschung Und Weiterbildung
Diabetes/Cardiovascular Disease, Markt 15, 23758, Oldenburg In Holstein
ClinPhenomics CVC GmbH
Diabetes/Cardiovascular Disease, Alfred-Lippmann-Straße 6, Rohrbach, St. Ingbert
Innodiab Forschung GmbH
Diabetes/Cardiovascular Disease, Eleonorastrasse 42, Ruettenscheid, Essen
Diabetes Und Stoffwechselpraxis Bochum
Diabetes/Cardiovascular Disease, In Der Hoennebecke 80, Hoentrop, Bochum
Bag Diabeteszentrum Dr. Tews & Partner
Diabetes/Cardiovascular Disease, 4 Obergeschoss, Herzbachweg 14e, Gelnhausen

Italy

8 sites · Ongoing, recruitment ended
Magna Graecia University Of Catanzaro
Reparto di Medicina Interna, Viale Europa - Localita Germaneto, 88100, Catanzaro
University Hospital Consorziale Policlinico
U.O Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Piazzale Giulio Cesare 11, 70124, Bari
Pisan University Hospital
Dipartimento di Medicina Clinica e Sperimentale - Divisione di Malattie del Metabolismo e Diabetolog, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Dipartimento ProMISE, Via Del Vespro 129, 90127, Palermo
Azienda Socio Sanitaria Locale N 2 Della Gallura
SC Diabetologia, Via Bazzoni Sircana 2/2/a, 07026, Olbia
Centro Cardiologico Monzino S.p.A.
Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, Via Carlo Parea 4, 20138, Milan
ASL To5
S.C. Diabetologia Territoriale-Sede di Moncalieri, Via Vittime Di Bologna 20, 10024, Moncalieri
Azienda Ospedaliera Universitaria Federico II Di Napoli
U.O.S.D Medicina Interna ad Indirizzo Diabetologico, Via Sergio Pansini 5, 80131, Naples

Romania

7 sites · Ongoing, recruitment ended
Milena Sante S.R.L.
Diabet, nutritie si boli metabolice, Strada Balcescu Nicolae Nr 31, 800001, Galati
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Diabetes-Nutrition-Metabolic Disorders, Strada Crisului Nr. 1, 500283, Brasov
Diabdana S.R.L.
Diabetes, Calea Republicii Nr 77, 410147, Oradea
Clinica Korall S.R.L.
Diabetes, P-Ta Eroii Revolutiei, Corp A Apartament M-2 Nr 22, Satu Mare
Gama Diamed S.R.L.
Diabetes, nutrition & metabolic diseases, T S Saveanu Nr 1, 905500, Mangalia
Nutrilife S.R.L.
Diabet zaharat, boli metabolice, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Diabmed Dr. Popescu Alexandrina S.R.L.
DIABET ZAHARAT, NUTRITIE BOLI METABOLICE, Strada Sighet Nr 4, 100163, Ploiesti

Slovakia

5 sites · Ongoing, recruitment ended
ProDia s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Hliniky 699/12, 017 01, Povazska Bystrica
ENDIANT s.r.o.
Ambulancia diabetologie a porúch látkovej premeny a výživy, Csl. Armady 2105/80, 920 01, Hlohovec
Iridia s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Turciansky Peter 139, 038 41, Turciansky Peter
JAL s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Slowackeho 10, Ruzinov, Bratislava
Medikals s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, E. Bellusa 8, 921 01, Piestany

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Germany 2023-01-27 2023-01-31 2023-10-31
Italy 2023-02-17 2023-03-06 2023-10-31
Romania 2023-02-08 2023-02-10 2023-10-31
Slovakia 2023-02-01 2023-02-09 2023-10-31

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 141 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D4_Patient facing documents_copyright statement 1.0
Protocol (for publication) GPHE_b_ Protocol track change comparison from GPHE_a__Redacted B
Protocol (for publication) LY3298176 GPHE Harmonized Clinical Protocol reversion_Redacted C
Protocol (for publication) LY3298176 GPHE_b_ Harmonized Clinical Protocol Amendment_Redacted B
Recruitment arrangements (for publication) I8H-MC-GPHE_List of sites_Redacted 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K2_GPHE_Advertisements for Subject Recruitment 1.0
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_ApptReminderCard 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_CarePartnerBrochure 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_Doctor-to-Patient Letter 2.0
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_Doctor-to-Patient Letter V2_IT_IT 2.0
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_Dr-to-Dr Letter 2.0
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_Dr-to-Dr Letter V2_IT_IT 2.0
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_HypoglycemicBrochure 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_RecruitmentBrochure 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_RecruitmentPoster 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_ReminderMagnet 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_ReminderMirrorCling 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_StudyFolder 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_ThankYouCard 1
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_Visit Guide 2
Recruitment arrangements (for publication) K2_Lilly_SURPASS-EARLY_Visit Guide IT_Copy Table 2
Recruitment arrangements (for publication) K2_Recruitment material_Doctor-to-Doctor Letter_Copy 1
Recruitment arrangements (for publication) K2_Recruitment material_Doctor-to-Patient Letter 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Doctor-to-Patient Letter_V1_07Dec2022 1
Recruitment arrangements (for publication) K2_Recruitment material_List of planned sites_Redacted 2.1
Recruitment arrangements (for publication) K2_Recruitment material_List of sites_Redacted 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient Facing Doc For Publication 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitement and ICF procedure 1
Recruitment arrangements (for publication) List of Planned Sites and Subjects_CTR Part II_GPHE N/A
Recruitment arrangements (for publication) List of Planned Sites and Subjects_CTR Part II_GPHE_TC N/A
Recruitment arrangements (for publication) Recruitment arrangements 2.0
Recruitment arrangements (for publication) Recruitment arrangements_ITA 1.0
Subject information and informed consent form (for publication) 028656_Lilly_SURPASS-EARLY_RecruitmentPoster_M_IT-IT 1
Subject information and informed consent form (for publication) 028656_Lilly_SURPASS-EARLY_RecruitmentPoster_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028656_Lilly_SURPASS-EARLY_RecruitmentPoster_M_SKSK 1
Subject information and informed consent form (for publication) 028657_Lilly_SURPASS-EARLY_RecruitmentBrochure_M_IT-IT 1
Subject information and informed consent form (for publication) 028657_Lilly_SURPASS-EARLY_RecruitmentBrochure_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028657_Lilly_SURPASS-EARLY_RecruitmentBrochure_M_SKSK 1
Subject information and informed consent form (for publication) 028658_Lilly_SURPASS-EARLY_Doctor-to-Patient Letter_072122_IT-IT 1.0
Subject information and informed consent form (for publication) 028658_Lilly_SURPASS-EARLY_Doctor-to-Patient Letter_RO-RO 2.0
Subject information and informed consent form (for publication) 028659_Lilly_SURPASS-EARLY_ThankYouCard_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028659_Lilly_SURPASS-EARLY_ThankYouCard_M_SK-SK 1
Subject information and informed consent form (for publication) 028659_Lilly_SURPASS-EARLY_ThankYouCard_MITIT 1
Subject information and informed consent form (for publication) 028660_Lilly_SURPASS-EARLY_ApptReminderCard_M_IT-IT 1
Subject information and informed consent form (for publication) 028660_Lilly_SURPASS-EARLY_ApptReminderCard_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028660_Lilly_SURPASS-EARLY_ApptReminderCard_M_SKSK 1
Subject information and informed consent form (for publication) 028661_Lilly_SURPASS-EARLY_VisitGuide_M_IT-IT 1
Subject information and informed consent form (for publication) 028661_Lilly_SURPASS-EARLY_VisitGuide_M_RO-RO 2.0
Subject information and informed consent form (for publication) 028661_Lilly_SURPASS-EARLY_VisitGuide_M_SKSK 1
Subject information and informed consent form (for publication) 028662_Lilly_SURPASS-EARLY_CarePartnerBrochure_M_IT-IT 1
Subject information and informed consent form (for publication) 028662_Lilly_SURPASS-EARLY_CarePartnerBrochure_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028662_Lilly_SURPASS-EARLY_CarePartnerBrochure_M_SKSK 1
Subject information and informed consent form (for publication) 028663_Lilly_SURPASS-EARLY_ReminderMagnet_M_ITIT 1
Subject information and informed consent form (for publication) 028663_Lilly_SURPASS-EARLY_ReminderMagnet_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028663_Lilly_SURPASS-EARLY_ReminderMagnet_M_SK-SK 1
Subject information and informed consent form (for publication) 028664 _Lilly_SURPASS-EARLY_ReminderMirrorCling_M-ITIT 1
Subject information and informed consent form (for publication) 028664_Lilly_SURPASS-EARLY_ReminderMirrorCling_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028664_Lilly_SURPASS-EARLY_ReminderMirrorCling_M_SK-SK 1
Subject information and informed consent form (for publication) 028665_Lilly_SURPASS-EARLY_HypoglycemicBrochure_M_IT-IT 1
Subject information and informed consent form (for publication) 028665_Lilly_SURPASS-EARLY_HypoglycemicBrochure_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028665_Lilly_SURPASS-EARLY_HypoglycemicBrochure_M_SK-SK 1
Subject information and informed consent form (for publication) 028666_Lilly_SURPASS-EARLY_StudyFolder_M_ITIT 1
Subject information and informed consent form (for publication) 028666_Lilly_SURPASS-EARLY_StudyFolder_M_RO-RO 1.0
Subject information and informed consent form (for publication) 028666_Lilly_SURPASS-EARLY_StudyFolder_M_SK-SK 1
Subject information and informed consent form (for publication) 28669_Lilly_SURPASS-EARLY_Doctor-to-Doctor Letter_Copy Only_IT-IT 1.0
Subject information and informed consent form (for publication) 28669_Lilly_SURPASS-EARLY_Doctor-to-Doctor Letter_Copy Only_RORO 2.0
Subject information and informed consent form (for publication) Certificate-Romania- Greenphire ClinCard Msg Templates - ROW 1.0
Subject information and informed consent form (for publication) Certificate-Romania-Greenphire_ClinCard_Card_Carrier 1.0
Subject information and informed consent form (for publication) Certificate-Romania-Greenphire_ClinCard_Cardholder_FAQ_EU 1.0
Subject information and informed consent form (for publication) Certificate-Romania-Greenphire_Fee_Schedule 1.0
Subject information and informed consent form (for publication) German - Greenphire_ClinCard_Card_Carrier 1
Subject information and informed consent form (for publication) GPHE_ICF_Patient Reimbursement_Greenphire_Redacted 2
Subject information and informed consent form (for publication) GPHE_ICF_Patient Reimbursement_Greenphire_TC_Redacted 1
Subject information and informed consent form (for publication) GPHE_ICF_Patient Remibursement_Thuroczy_Redacted 1
Subject information and informed consent form (for publication) GPHE_ICF_TC_RO 4.0
Subject information and informed consent form (for publication) GPHE-ICF_Main_Final_Redacted 7.0
Subject information and informed consent form (for publication) I8F-MC-GPHE _Lettera al Medico Curante_Italia TC 3.0
Subject information and informed consent form (for publication) I8F-MC-GPHE _Lettera al Medico Curante_Italia_Redacted 3.0
Subject information and informed consent form (for publication) I8F-MC-GPHE_Cover Letter_Retinal Exam_IT 1.0
Subject information and informed consent form (for publication) I8F-MC-GPHE_Diary_Trans_Paper_Slovak-SK 2
Subject information and informed consent form (for publication) I8F-MC-GPHE_Foglio Informativo e Consenso Informato_Italia 4.0
Subject information and informed consent form (for publication) I8F-MC-GPHE_Foglio Informativo e Consenso Informato_Italia TC_QC 3.0
Subject information and informed consent form (for publication) I8F-MC-GPHE_Foglio Informativo e Consenso Informato_Italia_TC 4.0
Subject information and informed consent form (for publication) I8F-MC-GPHE_ICF_Greenphire_RO_clean 1.0
Subject information and informed consent form (for publication) I8F-MC-GPHE_ICF_RO_Romanian_Clean 4.0
Subject information and informed consent form (for publication) I8F-MC-GPHE_SF-36_Acute_WS_Paper_Slovak-SK 2
Subject information and informed consent form (for publication) I8F-MC-GPHE_SVK_Main ICF_clean_Redacted 2.2
Subject information and informed consent form (for publication) I8F-MC-GPHE_SVK_Main ICF_clean_Redacted 3.1
Subject information and informed consent form (for publication) I8F-MC-GPHE_SVK_Main ICF_TC_Redacted 3.1
Subject information and informed consent form (for publication) I8F-MC-GPHE_SVK_Main ICF_TC_Redacted 2.2
Subject information and informed consent form (for publication) ICF_Main_TC_Redacted 7.0
Subject information and informed consent form (for publication) Insert_Control Solution_Level 2_4_AgaMatrix_svk 1
Subject information and informed consent form (for publication) Insert_Test Strip_AgaMatrix_Jazz_svk 1
Subject information and informed consent form (for publication) IW-SP_Cert_Slovak-Slovakia_HRA_Redacted 1
Subject information and informed consent form (for publication) IWQOL-Lite-CT_AU_deu_CoT 1.1
Subject information and informed consent form (for publication) L1_ICF Amendment Summary_clean 1.0
Subject information and informed consent form (for publication) L1_Informed Consent Form_Summary of Changes 2
Subject information and informed consent form (for publication) L1_Informed Consent Form_Summary of Changes_TC 2
Subject information and informed consent form (for publication) L1_Informed Consent Form_Summary of Changes_v1_17-Apr-2024 1
Subject information and informed consent form (for publication) L1_SIS and ICF Amendment Summary 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_ICF DPA_V1_10Jun2022 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted 3.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted_30Nov2022 2.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted_V2_13Oct2022 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_TC_Redacted 2.2
Subject information and informed consent form (for publication) L2_ Other subject information material_Coverletter_RetinalExam 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material_Gebrauchsanweisung_Tirzepatide 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material_Greenphire_ClinCard_Cardholder_FAQ 3.0
Subject information and informed consent form (for publication) L2_ Other subject information material_Greenphire_ClinCard_Msg_Template 6.0
Subject information and informed consent form (for publication) L2_ Other subject information material_Greenphire_Fee_Schedule 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material_Patient_ID_Card_Draft 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material_Reservierungsauftragsformular_redacted 1.0
Subject information and informed consent form (for publication) L2_ Other subject information material_Template_Generic_Clincard 3.0
Subject information and informed consent form (for publication) L2_Other subject information material_Clario Product Guide 8
Subject information and informed consent form (for publication) L2_Other subject information material_Cover Letter_Retinal Exam_SK 1
Subject information and informed consent form (for publication) L2_Other subject information material_Greenphire_Submission_Overview 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Guide_Owners_AgaMatrix_Jazz Wireless 2 1
Subject information and informed consent form (for publication) L2_Other subject information material_IFU 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Information Card 1
Subject information and informed consent form (for publication) L2_Other subject information material_Retinal Exam Intake Form_SK 2.1
Subject information and informed consent form (for publication) L2_Other subject information material_Visit Guide 2
Subject information and informed consent form (for publication) Patient Facing Doc For Publication Template 1.0
Subject information and informed consent form (for publication) Patient Facing Doc For Publication Template 1.0
Subject information and informed consent form (for publication) Patient Information Card 1.0
Subject information and informed consent form (for publication) Romania-EC_packet_w_Data_Privacy_as_applied_to_GP 6.0
Subject information and informed consent form (for publication) Romania-Greenphire ClinCard Msg Templates - ROW 6.0
Subject information and informed consent form (for publication) Romania-Greenphire_ClinCard_Card_Carrier 1.0
Subject information and informed consent form (for publication) Romania-Greenphire_ClinCard_Cardholder_FAQ_EU 3.0
Subject information and informed consent form (for publication) Romania-Greenphire_Fee_Schedule 4.0
Subject information and informed consent form (for publication) Template - Greenphire EU Generic ClinCard 3.0
Subject information and informed consent form (for publication) TIRZEPATIDE-CT-GPHE-IFU_IT 1.0
Subject information and informed consent form (for publication) TIRZEPATIDE-CT-GPHE-IFU_RO 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis a_ENG_2022-501073-40-00_Redacted 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis b_ENG_2022-501073-40-00_Redacted 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis c_ENG_2022-501073-40-00_Redacted 1.0
Synopsis of the protocol (for publication) D1_Protocol synopsis_SK_2022-501073-40-00 a
Synopsis of the protocol (for publication) GPHE RO_Protocol Synopsis 1
Synopsis of the protocol (for publication) GPHE_CZ_Protocol synopsis 1.1
Synopsis of the protocol (for publication) GPHE_DE_Protocol Synopsis 1
Synopsis of the protocol (for publication) GPHE_ITA_Protocol Synopsis 1

Application history

15 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-08-16 Germany Acceptable
2022-11-28
 2022-11-29
2 SUBSTANTIAL MODIFICATION SM-1 2022-12-08 Germany Acceptable 2023-01-27
3 SUBSTANTIAL MODIFICATION SM-2 2022-12-09 Acceptable 2023-01-25
4 SUBSTANTIAL MODIFICATION SM-3 2022-12-09 Acceptable 2023-02-07
5 SUBSTANTIAL MODIFICATION SM-4 2022-12-09 Acceptable 2023-02-07
6 SUBSTANTIAL MODIFICATION SM-5 2023-04-27 Germany Acceptable
2023-07-03
 2023-07-07
7 SUBSTANTIAL MODIFICATION SM-6 2023-09-25 Acceptable 2023-11-15
8 SUBSTANTIAL MODIFICATION SM-7 2023-12-21 Acceptable 2024-02-19
9 SUBSTANTIAL MODIFICATION SM-8 2024-05-07 Germany Acceptable
2024-07-08
 2024-07-08
10 SUBSTANTIAL MODIFICATION SM-9 2024-10-15 Acceptable 2024-12-12
11 NON SUBSTANTIAL MODIFICATION NSM-1 2025-07-31 Germany Acceptable 2025-07-31
12 SUBSTANTIAL MODIFICATION SM-10 2025-08-29 Germany Acceptable
2025-10-29
 2025-10-29
13 NON SUBSTANTIAL MODIFICATION NSM-3 2025-11-24 Germany Acceptable
2025-10-29
 2025-11-24
14 SUBSTANTIAL MODIFICATION SM-12 2025-11-26 Germany Acceptable 2025-12-05
15 NON SUBSTANTIAL MODIFICATION NSM-4 2026-02-26 Germany Acceptable 2026-02-26

Related clinical trials