CompletedPhase 3ACTRN12619001440112

INTIMET: INsulin Resistance in Type 1 Diabetes Managed with METformin

Effect of metformin on hepatic and peripheral insulin resistance in adults with type 1 diabetes: protocol of a double-blind placebo controlled, randomised trial

Sponsor

Garvan Institute of Medical Research

Enrollment

60 participants

Start Date

Dec 10, 2019

Study Type

Interventional

Conditions

Type 1 Diabetes

Summary

This is a detailed study of liver and muscle insulin resistance in adults with type 1 diabetes. The investigators will study the efficacy of adjunctive metformin in reversing insulin resistance and improve glucometabolic status, endothelial health and other parameters. Predictors of response to metformin will be assessed.

Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 55 Yearss

Inclusion Criteria7

T1D and controls without diabetes:
Age: adult (ages 20-55)
Premenopausal (if female)
T1D:
< 10 years since diagnosis of diabetes
Fasting c-peptide < 0.3nmol/L)
HbA1c less than or equal to 9.5%

Exclusion Criteria9

Current smoking
Current or planned prescription of medications that affect glucose metabolism (glucocorticoids, antipsychotics, immunosuppressants).
Exposure to metformin within the last 30 days
Alcohol intake > 20g/day in women or > 40g/day in men
Weight change > 5% in last 3 months or history of bariatric surgery
Pregnancy, breastfeeding, or childbearing potential not willing to avoid pregnancy during the study
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).
Diabetic ketoacidosis or severe hypoglycaemia (hypoglycaemia requiring third-party assistance) in the last 6 months.
A history of a psychological illness or condition that would interfere with the patient’s ability to understand the requirements of the study.

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Interventions

Active arm: oral metformin 1500mg extended release daily (as 500mg extended release tablets three times a day) titrated from initial dose 500mg to target 1500mg over 3 weeks (or maximum tolerated up

Active arm: oral metformin 1500mg extended release daily (as 500mg extended release tablets three times a day) titrated from initial dose 500mg to target 1500mg over 3 weeks (or maximum tolerated up to 1500mg) for 26 weeks post initiation of treatment. Adherence will be monitored with drug tablet return.