Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment

• Status: Recruiting
• Trial end date: 2022-11-29
• Target enrollment: 0
• Participant gender: All

Summary

Investigators aim is to conduct an RCT to study the effect of adjunct metformin treatment to insulin monotherapy in patients with type 1 diabetes, targeting the intestinal incretin secretion. The patients will be randomly allocated to metformin or placebo treatment for 4 months

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Institute for the Study of Sepsis
• Treatments: Gastric Inhibitory Polypeptide; Hormones; Incretins; Metformin

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year of diagnosis)

• Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)

Exclusion Criteria:

• Any cardiovascular disease within the last 3 months

• NYHA stage 3 or 4 heart failure

• Uncontrolled angina

• Liver failure [AST>135 IU/L or ALT>129IU/L (3 x the upper normal limit)] • Kidney failure or GFR<60 ml/min/1.73m2

• Gastrointestinal disease or gastroparesis

• Prior diagnosis of cancer within 2 years

• Other medication that affect glucose metabolism within the last 3 months (metformin, SGLT2, GLP-1 analogues, amylin analogues, systemic glucocorticosteroids)

• Untreated or uncontrolled thyroid disease

• Pregnancy or breastfeeding

• Alcohol consumption > 2-drinks per day or other substance abuse