A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Start 7 Jun 2023 · End 12 Aug 2024 · Status Ended · 4 EU/EEA countries · 23 sites · Protocol I8F-MC-GPIH

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ended

Participants planned 250

Countries 4

Sites 23

Type 2 Diabetes

To demonstrate that switching from once weekly dulaglutide to once weekly tirzepatide is superior to continuing and escalating dulaglutide for HbA1c change from baseline to Week 40

Key facts

Sponsor: Eli Lilly Cork Limited
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trial duration: 7 Jun 2023 → 12 Aug 2024
Decision date (initial): 2023-02-14
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2022-500101-41-00
WHO UTN: U1111-1282-3333
ClinicalTrials.gov: NCT05564039

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To demonstrate that switching from once weekly dulaglutide to once weekly tirzepatide is superior to continuing and escalating dulaglutide for HbA1c change from baseline to Week 40

Secondary objectives 1

To demonstrate that switching from once weekly dulaglutide to once weekly tirzepatide is superior to continuing and escalating dulaglutide for weight change from baseline to Week 40.

Conditions and MedDRA coding

Type 2 Diabetes

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Parallel Assignment N/A	Randomised Controlled	None		Experimental: Participants will receive tirzepatide subcutaneously (SC) Active Comparator: Participants will escalate their dulaglutide dose SC

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

Have type 2 diabetes
Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol)
Are currently on a stable dose of dulaglutide weekly (0.75 mg or 1.5 mg) for at least 6 months prior to screening
No treatment with oral antihyperglycemic medication (OAM), or on a stable dose of up to 3 OAMs, which may include metformin, SGLT-2i, and/or sulfonylurea, for at least 3 months before screening
Have stable body weight (±5%) during the 90 days preceding screening
Have BMI ≥25 kilogram/square meter (kg/m²)

Exclusion criteria 10

Have type 1 diabetes
Have a history of chronic or acute pancreatitis
Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or Nonproliferative diabetic retinopathy requiring acute treatment
Have NYHA Functional Classification Class IV CHF
Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
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
Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label)
Have a history of reduction of dose of dulaglutide, due to intolerability, without successful reescalation
Have any of these cardiovascular conditions within 60 days prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or hospitalization due to congestive heart failure (CHF)
Have been treated with 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

Change from baseline in Hemoglobin A1c (HbA1c)

Secondary endpoints 12

Change from Baseline in Weight
Percentage of Participants Who Achieve HbA1c <7%
Percentage of Participants Who Achieve HbA1c ≤6.5%
Percentage of Participants Who Achieve HbA1c <5.7%
Percentage of Participants Who Achieve Weight loss from Baseline of ≥5%
Percentage of Participants Who Achieve Weight loss from Baseline of ≥10%
Percentage of Participants Who Achieve Weight loss from Baseline of ≥15%
A Composite Endpoint of HbA1c, Weight loss and Hypoglycemia A composite endpoint defined as HbA1c ≤6.5%, weight loss ≥10%, and no hypoglycemia, defined as blood glucose <54 milligram/deciliter (mg/dL) (<3.0 millimole/liter [mmol/L]) and/or severe hypoglycemia
Change from Baseline in Fasting Serum Glucose
Change from Baseline in Waist Circumference
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Impact of Weight on Quality of Life-Clinical Trials Version (IWQOL-Lite-CT) - Physical Functioning Score

Investigational products

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

Test 6

Tirzepatide

PRD7107375 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 15 mg milligram(s)
Max total dose: 450 mg milligram(s)
Max treatment duration: 40 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107379 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 15 mg milligram(s)
Max total dose: 450 mg milligram(s)
Max treatment duration: 40 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107377 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 15 mg milligram(s)
Max total dose: 450 mg milligram(s)
Max treatment duration: 40 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107378 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 15 mg milligram(s)
Max total dose: 450 mg milligram(s)
Max treatment duration: 40 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107376 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 15 mg milligram(s)
Max total dose: 450 mg milligram(s)
Max treatment duration: 40 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Tirzepatide

PRD7107380 · Product

Active substance: Tirzepatide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 15 mg milligram(s)
Max total dose: 450 mg milligram(s)
Max treatment duration: 40 Week(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY
Paediatric formulation: No
Orphan designation: No

Comparator 4

Dulaglutide

SUB130484 · Substance

Active substance: Dulaglutide
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INJECTION
Max daily dose: 4.5 mg milligram(s)
Max total dose: 174 mg milligram(s)
Max treatment duration: 40 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: INJECTION
Max daily dose: 4.5 mg milligram(s)
Max total dose: 174 mg milligram(s)
Max treatment duration: 40 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: INJECTION
Max daily dose: 4.5 mg milligram(s)
Max total dose: 174 mg milligram(s)
Max treatment duration: 40 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: INJECTION
Max daily dose: 4.5 mg milligram(s)
Max total dose: 174 mg milligram(s)
Max treatment duration: 40 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 18

Colesevelam

SCP8250269 · ATC

Active substance: Colesevelam
Route of administration: ORAL
Max daily dose: 3.75 g gram(s)
Max total dose: 1155 g gram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: C10AC04 — COLESEVELAM
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ondansetron

SCP15701768 · ATC

Active substance: Ondansetron
Route of administration: ORAL
Max daily dose: 24 mg milligram(s)
Max total dose: 7392 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: A04AA01 — ONDANSETRON
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: 500 IU international unit(s)
Max total dose: 154000 IU international unit(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: A10A — INSULINS AND ANALOGUES
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ertugliflozin

SUB182716 · Substance

Active substance: Ertugliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 15 mg milligram(s)
Max total dose: 4620 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dimeticone

SCP1155863 · ATC

Active substance: Dimeticone
Substance synonyms: Dimethyl polysiloxane, DIMETHICONE, DIMETHYLPOLYSILOXANE, DIMETHYLSILOXANE, POLY(DIMETHYLSILOXANE)
Route of administration: ORAL
Max daily dose: 16 mg milligram(s)
Max total dose: 4928 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: A07DA03 — LOPERAMIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dapagliflozin

SUB31650 · Substance

Active substance: Dapagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 10 mg milligram(s)
Max total dose: 3080 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Canagliflozin

SUB33463 · Substance

Active substance: Canagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 300 mg milligram(s)
Max total dose: 92400 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ertugliflozin

SUB182716 · Substance

Active substance: Ertugliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 15 mg milligram(s)
Max total dose: 4620 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bromocriptine

SCP2682283 · ATC

Active substance: Bromocriptine
Route of administration: ORAL
Max daily dose: 4.8 mg milligram(s)
Max total dose: 1478.4 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: N04BC01 — BROMOCRIPTINE
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
Max daily dose: 2000 mg milligram(s)
Max total dose: 616000 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: A10BA02 — METFORMIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Glucagon

SCP54118154 · ATC

Active substance: Glucagon
Route of administration: NASAL USE
Max daily dose: 6 mg milligram(s)
Max total dose: 1848 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: H04AA01 — GLUCAGON
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Empagliflozin

SUB35915 · Substance

Active substance: Empagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 25 mg milligram(s)
Max total dose: 7700 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Canagliflozin

SUB33463 · Substance

Active substance: Canagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 300 mg milligram(s)
Max total dose: 92400 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Empagliflozin

SUB35915 · Substance

Active substance: Empagliflozin
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 25 mg milligram(s)
Max total dose: 7700 mg milligram(s)
Max treatment duration: 44 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
Max daily dose: 300 mg milligram(s)
Max total dose: 92400 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: A10BF — ALPHA GLUCOSIDASE INHIBITORS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dapagliflozin

SUB31650 · Substance

Active substance: Dapagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 10 mg milligram(s)
Max total dose: 3080 mg milligram(s)
Max treatment duration: 44 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
Max daily dose: 20 mg milligram(s)
Max total dose: 6160 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: A10BB — SULFONAMIDES, UREA DERIVATIVES
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pioglitazone

SCP129581 · ATC

Active substance: Pioglitazone
Route of administration: ORAL
Max daily dose: 45 mg milligram(s)
Max total dose: 13860 mg milligram(s)
Max treatment duration: 44 Week(s)
Authorisation status: Authorised
ATC code: A10BG03 — PIOGLITAZONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly Cork Limited

Sponsor organisation: Eli Lilly Cork Limited
Address: Island House Eastgate Road, Eastgate Business Park, Little Island Eastgate Business Park Little Island
City: Cork
Country: Ireland

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 10

Organisation	City, country	Duties
RWS Life Sciences Inc. ORG-100042348	East Hartford, United States	Other
Q2 Solutions LLC ORG-100017000	Ithaca, United States	Laboratory analysis
Bioagilytix Labs LLC ORG-100013030	Durham, United States	Laboratory analysis
Pharmaceutical Product Development LLC ORG-100016999	Highland Heights, United States	Laboratory analysis
PPD International Holdings LLC ORG-100007655	Zaventem, Belgium	Laboratory analysis
Veeva Systems Inc. ORG-100006053	Pleasanton, United States	Data management, E-data capture
Icon PLC ORG-100042517	Dublin 18, Ireland	Other
Greenphire LLC ORG-100041621	King Of Prussia, United States	Other
Iqvia Inc. ORG-100010622	Durham, United States	On site monitoring
Cleveland Clinic ORG-100028017	Cleveland, United States	Other

Locations

4 EU/EEA countries · 23 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ended	21	6
France	Not authorised	28	6
Germany	Ended	55	5
Romania	Ended	41	6
Rest of world United States, Mexico	—	105	—

Investigational sites

Belgium

6 sites · Ended

Verenigde Ziekenhuizen van Waas en Durme

Internal diseases, Moerlandstraat 1, 9100, Sint-Niklaas

Antwerp University Hospital

Endocrinology, diabetes and metabolic disease, Drie Eikenstraat 655, 2650, Edegem

Imelda

Endocrinology, Imeldalaan 9, 2820, Bonheiden

UZ Leuven

Endocrinology, Herestraat 49, 3000, Leuven

Het Ziekenhuisnetwerk Antwerpen

Endocrinology, Lange Bremstraat 70, 2170, Antwerp

Algemeen Ziekenhuis Damiaan Oostende

Endocrinology and diabetes, Gouwelozestraat 100, 8400, Ostend

France

6 sites · Not authorised

GIE Groupe hospitalier Paris Saint-Joseph

Service de diabétologie endocrinologie et nutrition, 185 Rue Raymond Losserand, 75674, Paris Cedex 14

Centre De Recherche Clinique Portes Du Sud

Consultation endocrinologie diabétologie, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux

Assistance Publique Hopitaux De Marseille

Service de Nutrition, Endocrinologie, Maladies Métaboliques, 80 Rue Brochier, 13005, Marseille

Centre Hospitalier Universitaire De Montpellier

Nutrition Diabetes, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5

Centre Hospitalier Universitaire De Toulouse

service de diabetologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9

Centre Hospitalier Sud Francilien

Endocrino-diabétologie, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes

Germany

5 sites · Ended

Innodiab Forschung GmbH

private practice, Eleonorastrasse 42, Ruettenscheid, Essen

Praxisinhaber Dr Ulrich Wendisch Dr Dominik Dahl Und Prof Dr Jens Aberle

private practice, Beselerstraße 2a, Groß Flottbek, Hamburg

Institut fuer Diabetesforschung Muenster GmbH

private practice, Hohenzollernring 70, Herz-Jesu, Muenster

Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

private practice, Galenstrasse 3, Spandau, Berlin

Red Institut Fur Medizinische Forschung Und Weiterbildung

private practice, Markt 15, 23758, Oldenburg In Holstein

Romania

6 sites · Ended

Diabdana S.R.L.

Diabetes, Calea Republicii Nr 77, 410147, Oradea

Easydiet S.R.L.

Easy Diet, Diabet, Nutritie si Boli Metabolice Department, Strada Mr. Sontu Gheorghe Nr 3, 011447, Bucharest

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

Mariodiab Clinic S.R.L.

Metabolic Disease Department, Block 75 Scara A, Bulevardul 15 Noiembrie Nr 75, Brasov

Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia

Diabet, Nutritie, Boli Metabolice Department, Strada Cosbuc George Nr 25a, Ap. 2, Baia Mare

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end
Belgium	2023-07-05	2024-08-07	2023-07-13	2023-10-09
Germany	2023-06-07	2024-07-23	2023-06-12	2023-10-09
Romania	2023-06-08	2024-08-07	2023-06-13	2023-10-09

Results and documents

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

Summary of results Art. 37(4) CTR

Title	Submission date	Status	Type
I8F-MC-GPIH_Final Summary of Results_2022-500101-41-00 SUM-90643	2025-07-16T03:13:42	Submitted	Summary of Results

Layperson summary Annex V

Title	Submission date	Status	Type
I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00	2025-08-11T18:59:15	Submitted	Laypersons Summary of Results
I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 German	2025-09-12T19:39:12	Submitted	Laypersons Summary of Results
I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 Romanian	2025-09-12T19:40:38	Submitted	Laypersons Summary of Results
I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 Belgium Dutch	2025-09-12T19:42:50	Submitted	Laypersons Summary of Results
I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 Belgium French	2025-09-12T19:44:11	Submitted	Laypersons Summary of Results

Documents 6 files

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

Type	Title	Version
Laypersons summary of results (for publication)	I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00	1
Laypersons summary of results (for publication)	I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 Belgium Dutch	1
Laypersons summary of results (for publication)	I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 Belgium French	1
Laypersons summary of results (for publication)	I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 German	1
Laypersons summary of results (for publication)	I8F-MC-GPIH Lay Person Summary of Results 2022-500101-41-00 Romanian	1
Summary of results (for publication)	I8F-MC-GPIH_Final Summary of Results_2022-500101-41-00	1

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2022-10-11	France	Acceptable with conditions 2023-02-13	2023-02-14
2	SUBSTANTIAL MODIFICATION	SM-2	2023-04-06		Acceptable 2023-05-22	2023-05-24
3	SUBSTANTIAL MODIFICATION	SM-4	2023-07-31		Acceptable	2023-08-21
4	SUBSTANTIAL MODIFICATION	SM-5	2024-05-02		Acceptable 2024-08-01	2024-08-02

A Study of Tirzepatide (LY3298176) in Adult Participants With Type 2 Diabetes Switching From Dulaglutide (SURPASS-SWITCH)

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Study design 1 period

Eligibility criteria

Inclusion criteria 6

Exclusion criteria 10

Endpoints

Primary endpoints 1

Secondary endpoints 12

Investigational products

Test 6

Comparator 4

Auxiliary 18

Sponsors and contacts

Eli Lilly Cork Limited

Scientific contact point

Public contact point

Third parties 10

Locations

By country

Investigational sites

Country notifications

Results and documents

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 6 files

Application history

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