Metformin in Longevity Study (MILES).

Plain-language summary

This study examined the effects of the drug Metformin compared with placebo in older individuals with impaired glucose tolerance. It included people over 60 who were not yet diabetic but showed impaired glucose regulation. It was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Albert Einstein College of Medicine

Intervention

Metformin, Placebo

Start date

10/1/2014

Estimated completion

12/1/2017

Countries

United States

Related genes

Locations

• The Bronx, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Men and women;
2. age \>60 years with IGT based on 75g OGTT (fasting plasma glucose \< 126 mg/dl, 2-hr glucose between 140 - 199 mg/dl);
3. this definition of IGT will include individuals with combined impaired fasting glucose (IFG) and IGT.

The investigators chose these inclusion criteria in order to study subjects who have evidence of impaired glucose regulation, but are not yet diabetic.

Exclusion Criteria:

1. Serious chronic or acute illness: cancer, clinically significant congestive heart failure, COPD, inflammatory conditions, serum creatinine \> 1.4 mg/dl (female) or \> 1.5 mg/dl (male), active liver disease, history of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) CVD event (MI, PTCA, CABG, stroke); history of bariatric or other gastric surgery, cigarette smoking, binge alcohol use (\>7 drinks in 24 hrs).
2. Treatment with drugs known to influence glucose metabolism (other diabetes medications, systemic glucocorticoids, pharmacologic doses of niacin)
3. Hypersensitivity to metformin or any component of the formulation