Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
504
Countries
1
Sites
3
Type 2 Diabetes Mellitus
To evaluate the efficacy of pharmacogenetic-guided treatment, compared with optimized standard treatment, in subjects with insufficiently controlled type 2 diabetes.
Key facts
- Sponsor
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 15 May 2025 → ongoing
- Decision date (initial)
- 2025-04-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ayuda Investigación Clínica Independiente del Instituto Carlos III (Expediente ICI21/00020).
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Efficacy, Safety
To evaluate the efficacy of pharmacogenetic-guided treatment, compared with optimized standard treatment, in subjects with insufficiently controlled type 2 diabetes.
Secondary objectives 5
- To assess the impact of treatment on HbA1c response according to the genetic variants.
- To evaluate the percentage of patients achieving the goal of dyslipidemia and its relationship with genetic variations present in those subjects.
- To evaluate the percentage of patients achieving the goal of blood pressure and its relationship with genetic variations present in those subjects.
- To evaluate incidence and relatedness of glucose-lowering drugs’ adverse events with genetic variations.
- To evaluate the safety and tolerability of the glucose-lowering drugs prescribed in each patient group.
Conditions and MedDRA coding
Type 2 Diabetes Mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period Study treatment will start in the randomization visit for 24 weeks.
|
Randomised Controlled | None | [{"id":145608,"code":1,"name":"Subject"}] | Experimental arm: Pharmacogenetic-guided treatment group: treatment for patients randomized to this arm will be selected according to previously identified genetic variations. Standard arm: Standard treatment group: treatment for patients randomized to this arm will be selected according to clinical guidelines. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Age 40-70 years old, included.
- Body Mass Index (BMI) 25-40 kg/m².
- Diagnosis of T2D according to the American Diabetes Association (ADA) criteria.
- Patients with T2D insufficiently controlled (HbA1c 7-9.5%) with current (≥6 months) “standard of care” treatment without use of insulin. Subject has provided written informed consent prior to any study specific procedure.
- Subject has provided written informed consent prior to any study specific procedure.
- Able and willing to comply with requested study visits and procedures.
- Contraceptive measures, only for female participants: • A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: - Is a woman of nonchildbearing potential (WONCBP) OR - Is a WOCBP and agrees to use a contraceptive method that is highly effective, [with a failure rate of 1-5%], during the study intervention period (to be effective before starting the intervention). Acceptable methods are the following: ○ Male (or female) condom ○ Contraceptive implant ○ IUD (intrauterine device) ○ Surgical sterilization (tubal ligation or partner's vasectomy) ○ Birth control pill ○ Contraceptive patch ○ Vaginal ring ○ Contraceptive injections A WOCBP must have a negative urine pregnancy test before the first administration of study intervention.
Exclusion criteria 12
- Treatment with insulin at the time of screening.
- HbA1c >9.5% at screening.
- Treatment with more than 3 glucose lowering drugs at the time of screening.
- Chronic renal disease defined as eGFR <30mL/min/1.73m² (many glucose-lowering drugs are not approved or require dosage adjustments for being used in these patients) at the screening visit.
- Hepatic insufficiency which contraindicates the use of glucose-lowering drugs.
- Currently receiving treatment in another investigational drug study, or less than 30 days since ending treatment on another investigational drug study.
- Pregnancy or lactation.
- Women of child bearing potential with no effective contraceptive methods.
- New York Heart Association (NYHA) Class III or IV congestive heart failure.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- Subject is staff personal directly involved with the study or is a family member of the investigational study staff.
- Life expectancy predicted to be <2 years.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients achieving goal HbA1c ≤7% at Week 24 in experimental arm versus control arm.
Secondary endpoints 5
- Comparison between patients who have achieved the goal of HbA1c ≤7% at baseline (excluded for randomization) with patients who did not (included for the randomization).
- Percentage of patients achieving the goal of dyslipidemia at Week 24: - LDL-C of <70 mg/dL without documented CVD at baseline. - LDL-C of <55 mg/dL with documented CVD at baseline.
- Percentage of patients achieving the goal of blood pressure (<140/90 mmHg) at Week 24.
- Number of glucose-lowering drugs’ adverse events reported for each genetic variation identified.
- Proportion of patients in each group presenting each clinical outcome over the study period: • Adverse events (AEs) related to glucose-lowering drugs • Serious Adverse events (SAEs) • Changes in clinical laboratory parameters, including renal and hepatic function. • Changes in vital signs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
Jardiance 10 mg film-coated tablets
PRD1594848 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/010
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Forxiga 10 mg film-coated tablets
PRD2427550 · Product
- Active substance
- Dapagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK01 — -
- Marketing authorisation
- EU/1/12/795/009
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sitagliptin 50mg Film-coated Tablets
PRD10184501 · Product
- Active substance
- Sitagliptin
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BH01 — -
- Marketing authorisation
- PL 29831/0732
- MA holder
- WOCKHARDT UK LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Invokana 100 mg film-coated tablets
PRD3349139 · Product
- Active substance
- Canagliflozin
- Substance synonyms
- JNJ-28431754, JNJ-28431754-ZAE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK02 — -
- Marketing authorisation
- EU/1/13/884/002
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trulicity 1.5 mg solution for injection in pre-filled pen
PRD1802565 · Product
- Active substance
- Dulaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1.5 mg milligram(s)
- Max total dose
- 1.5 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ05 — -
- Marketing authorisation
- EU/1/14/956/008
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ozempic 0.5 mg solution for injection in pre-filled pen
PRD11350768 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/17/1251/012
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
GLUCOPHAGE 1000 mg potahované tablety
PRD10024243 · Product
- Active substance
- Metformin Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BA02 — METFORMIN
- Marketing authorisation
- 18/155/02-C
- MA holder
- MERCK SANTÉ S.A.S.
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3949424 · Product
- Active substance
- Vildagliptin
- Substance synonyms
- LAF237, LAF-237
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BH02 — -
- Marketing authorisation
- EU/1/07/414/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Trajenta 5 mg film-coated tablets
PRD291575 · Product
- Active substance
- Linagliptin
- Substance synonyms
- BI 1356 BS
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BH05 — -
- Marketing authorisation
- EU/1/11/707/001
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pioglitazone Mylan 15 mg compresse
PRD2547664 · Product
- Active substance
- Pioglitazone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 45 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BG03 — PIOGLITAZONE
- Marketing authorisation
- 040476020
- MA holder
- MYLAN S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Sponsor organisation
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Address
- Avenida Menendez Y Pelayo 4
- City
- Valencia
- Postcode
- 46010
- Country
- Spain
Scientific contact point
- Organisation
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Contact name
- Sergio Martínez Hervás
Public contact point
- Organisation
- Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
- Contact name
- Unidad de Investigación Clínica y Ensayos Clínicos (UICEC)
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 504 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Clinico Universitario De Valencia
Endocrinology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital General Universitario De Valencia
Endocrinology, Avenida Del Tres Cruces 2, 46014, Valencia
Hospital Regional Universitario de Málaga
Endoncrinolgoy and Nutrition, Avenida de Carlos Haya s/n, Spain, Malaga
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2025-05-15 | 2025-05-26 | 2025-11-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-520686-46-00 | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangements | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Canagliflozin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dapagliflozin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dulaglutide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Empagliflozin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Linagliptin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Metformin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pioglitazone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Semaglutide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Sitagliptin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vildagliptin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Forxiga_2017_08_28_ok | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Galvus_2012_07_23_ok | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Invokana_2018_07_26_ok | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Metformina Normon_2019_02_UN_ok | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Pioglitazone_2022_09_21_ok | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Semaglutide_2022_09_21_ok | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Trajenta_2016_03_22_ok | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Trulicity_2019_08_23_ok | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS 2025-520686-46-00 | 2.1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Spain | Acceptable 2025-04-28
|
2025-04-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-21 | Spain | Acceptable | 2025-09-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-15 | Spain | Acceptable | 2025-09-15 |