INTIMET: INsulin Resistance in Type 1 Diabetes Managed with METformi

Phase 3

Completed

• Conditions: Type 1 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619001440112
• Lead Sponsor: Garvan Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-17
• Study Completion: 2022-02-16
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

T1D and controls without diabetes:
1. Age: adult (ages 20-55)
2. Premenopausal (if female)

T1D:
1. < 10 years since diagnosis of diabetes
2. Fasting c-peptide < 0.3nmol/L)
3. HbA1c less than or equal to 9.5%

Exclusion Criteria

1. Current smoking
2. Current or planned prescription of medications that affect glucose metabolism (glucocorticoids, antipsychotics, immunosuppressants).
3. Exposure to metformin within the last 30 days
4. Alcohol intake > 20g/day in women or > 40g/day in men
5. Weight change > 5% in last 3 months or history of bariatric surgery
6. Pregnancy, breastfeeding, or childbearing potential not willing to avoid pregnancy during the study
7. Known major organ dysfunction (eGFR < 60, liver disease transaminases > 3 times the upper limit of normal, cardiac event within the last 6 months, current cancer or uncontrolled thyroid dysfunction).
8. Diabetic ketoacidosis or severe hypoglycaemia (hypoglycaemia requiring third-party assistance) in the last 6 months.
9. A history of a psychological illness or condition that would interfere with the patient’s ability to understand the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in hepatic insulin resistance, assessed by hyperinsulinaemic euglycaemic clamp (with deuterated glucose tracers).[26 weeks post initiation of treatment ]