Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes - IMPACT-1D

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003121-29-FR

Enrollment

230

Registered

2019-12-10

Start date

2020-03-04

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular calcification and type 1 diabetes

Interventions

Trade Name: METFORMINE ARROW LAB 1000 mg, comprimé pelliculé sécable Product Name: METFORMINE ARROW LAB® 1000 mg Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN CAS Number: 657-24-9 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Type 1 diabetes - Women and Men = 18 years old and = 80 years old with: *Complications: -diabetic retinopathy and/or -nephropathy (with creatinine clearance = 60 mL/mn) and/or -neuropathy and/or -peripheral arterial occlusive disease and/or -cardiopathy and/or -stroke and/or *cardiovascular risk factors - hypertension and/or - dyslipidemia (HDL 1.9g/L or treated dyslipidemia) and/or - tobacco use (old or active smoking greater than 5 pack years) and/or *Diabetes duration >20 years - For women in childbearing age, effective contraception during the whole trial - Signed written informed consent - Affiliation of a social security regime (patient with AME cannot be included) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Creatinine clearance of less than 3 months 11% - Chronic inflammatory disease or chronic immune-suppressive drugs intake - Participation in an another interventional trial (Jardé 1 and 2) or in the exclusion period of any other interventional study - Pregnancy woman (confirmed by a sanguine beta-HCG test) or breastfeeding woman - Patient under legal protection measure (tutorship or curatorship) or deprived of freedom or under measure of safety - Unable to consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To show that metformin, patients with type 1 diabetes but without chronic kidney disease, is able to slow below- knee arterial calcification;Secondary Objective: 1. To show that metformin, in patients with type 1 diabetes but without CKD, is able to slow below-knee arterial occlusive disease. 2. To show that metformin, in patients with type 1 diabetes but without CKD, is able to improve ankle and toe brachial indexes. 3. To show that metformin, in patients with type 1 diabetes but without CKD, is able to improve pulse wave velocity. 4. To show that metformin, in patients with type 1 diabetes but without chronic kidney disease, is able to slow coronary arterial calcification. 5. To conduct a subgroup analysis for the primary outcome to evaluate whether the effect of metformin on the difference of below-knee arterial calcification score evaluated by CT-scan at T0 and T2years varies according to initial below-knee arterial calcification score (= versus >400). ;Primary end point(s): Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To show that metformin, patients with type 1 diabetes but without chronic kidney disease, is able to slow below- knee arterial calcification;Secondary Objective: 1. To show that metformin, in patients with type 1 diabetes but without CKD, is able to slow below-knee arterial occlusive disease. 2. To show that metformin, in patients with type 1 diabetes but without CKD, is able to improve ankle and toe brachial indexes. 3. To show that metformin, in patients with type 1 diabetes but without CKD, is able to improve pulse wave velocity. 4. To show that metformin, in patients with type 1 diabetes but without chronic kidney disease, is able to slow coronary arterial calcification. 5. To conduct a subgroup analysis for the primary outcome to evaluate whether the effect of metformin on the difference of below-knee arterial calcification score evaluated by CT-scan at T0 and T2years varies according to initial below-knee arterial calcification score (= versus >400). ;Primary end point(s): Difference between below-knee arterial calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin.;Timepoint(s) of evaluation of this end point: 2 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. Difference between below-knee arterial ultrasonographic occlusion score at T0 and T2years in type 1 diabetic patients supplemented or not with metformin. 2. Difference between ankle and toe brachial indexes at T0 and T2years in type 1 diabetic patients supplemented or not with metformin. 3. Difference between pulse wave velocity at T0 and T2 years in type 1 diabetic patients supplemented or not with metformin. 4. Difference between coronary calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin. 5. Difference between below-knee arterial calcification score progression between T0 and T2years in type 1 diabetic patients treated or not with metformin and with initial below-knee arterial calcification score = and >400. ;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Secondary end point(s): 1. Difference between below-knee arterial ultrasonographic occlusion score at T0 and T2years in type 1 diabetic patients supplemented or not with metformin. 2. Difference between ankle and toe brachial indexes at T0 and T2years in type 1 diabetic patients supplemented or not with metformin. 3. Difference between pulse wave velocity at T0 and T2 years in type 1 diabetic patients supplemented or not with metformin. 4. Difference between coronary calcification score evaluated by CT-scan at T0 and T2years in type 1 diabetic patients treated or not with metformin. 5. Difference between below-knee arterial calcification score progression between T0 and T2years in type 1 diabetic patients treated or not with metformin and with initial below-knee arterial calcification score = and >400. ;Timepoint(s) of evaluation of this end point: 2 years

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Countries

France

Contacts

Public ContactSophie Courtial-Destembert

DRCI

sophie.courtial-destembert@aphp.fr33140275591

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026