Metformin in overweight adults with type 1 diabetes mellitus

Phase 2

• Conditions: Type 1 diabetes mellitus; Overweight/obesity; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612000660886
• Lead Sponsor: Professor Peter Clifton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Type 1 diabetes mellitus for at least 2 years diagnosed before the age of 25 years, BMI>=27 kg/m2, HbA1c>= 7.5%, age 18-65 years, CrCl >= 45 ml/min

Exclusion Criteria

Contraindications to metformin (such as hepatic failure, renal failure, lactation), hypoglycemic unawareness, pregnancy, history of drug or alcohol abuse, alcoholism, inability to comply, serious co-morbidities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose control measured as glycated hemoglobin (HbA1c) level in blood sample.[0, 3, 6, 9, 12 months];Body mass index (BMI), calculated based on measured weight and height.[0, 1, 3, 6, 9, 12 months];Insulin dose requirements, patients will be instructed to record daily insulin dose (units) in a diary.[0, 1, 3, 6, 9, 12 months]

Secondary Outcome Measures

Name	Time	Method
Fasting blood lipids measured in a blood sample.[0, 3, 6, 9, 12 months];Number of hypoglycemic events and adverse events such as feeling sick, vomiting, diarrhoea, stomach pain, loss of appetite and taste disturbances recorded by patients in a diary.[0, 1, 3, 6, 9,12 months];Waist/hip ratio calculated based on measured waist and hip circumference.[0,1, 3, 6, 9, 12 months];High sensitivity C-reactive protein (hsCRP) measured in a blood sample[0, 3, 6, 9, 12 months]