INTIMET: INsulin Resistance in Type 1 Diabetes Managed with METformin

Conditions

None listed

Brief 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.

Snaith JR, Olsen N, Evans J, Kowalski GM, Bruce CR, Samocha-Bonet D, Breit SN, Holmes-Walker DJ, Greenfield JR.

2025-11-24

10.1038/s41467-025-65951-1

1607-P: Estimation of Muscle and Hepatic Insulin Sensitivity in Type 1 Diabetes Adults Using Clinical and Research Biomarkers

ANDRZEJ S. JANUSZEWSKI, Jennifer Snaith, Greg M. Kowalski, Clinton R. Bruce, JANE HOLMES-WALKER et al. (7 authors)

Diabetes2024-06-14

10.2337/db24-1607-p

Insulin resistance in type 1 diabetes managed with metformin (INTIMET): Study protocol of a double‐blind placebo‐controlled, randomised trial

Jennifer Snaith, Dorit Samocha‐Bonet, Jennifer A. Evans, Zhixin Liu, Greg M. Kowalski et al. (8 authors)

Diabetic Medicine2021-03-2811 citations

10.1111/dme.14564

MON-LB113 Insulin Resistance in Type 1 Diabetes Managed With Metformin (INTIMET): Rationale and Study Design of a Randomised Placebo-Controlled Trial

Jennifer Snaith, Dorit Samocha‐Bonet, D. Jane Holmes–Walker, Jerry R. Greenfield

Journal of the Endocrine Society2020-04-011 citations

10.1210/jendso/bvaa046.2038

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 to 1500mg) for 26 weeks post initiation of treatment. Adherence will be monitored with drug tablet return.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

20 Years to 55 Years

Healthy volunteers

Yes

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.

Outcome results