Metformin treatment for diabetes prevention in Africa

A randomised placebo-controlled double-blind phase II trial to determine the effects of metformin versus placebo on glycaemia in HIV-infected persons with pre-diabetes in Tanzania.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76157257

Enrollment

360

Registered

2019-03-22

Start date

2019-11-05

Completion date

Unknown

Last updated

2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediabetes in person who are on HIV treatment Nutritional, Metabolic, Endocrine

Interventions

The intervention will be Metformin hydrochloride slow-release preparation, 2000 mg per day, compared with a matching placebo. The treatment will only be taken once a day. Participants who are HIV infe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV-positive on antiretroviral therapy (ART) for at least 6 months and considered stable on treatment (i.e. in regular attendance for care). 2. BMI>30 combined with either impaired fasting glucose (6.1 to 6.9 mmol/L) and/or impaired glucose tolerance at 2 hours (7.0 to 11.10 mmol/L) 3. BMI 6-months 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant women 2. Renal disease or renal dysfunction (eGFR<45) 3. Signs and symptoms of any form of acute metabolic acidosis including lactic acidosis and diabetic ketoacidosis 4. Other acute conditions with: 4.1 the potential to alter renal function including: dehydration, severe infection or shock 4.2 the potential to cause tissue hypoxia including decompensated heart failure, respiratory failure, recent myocardial infarction, shock 5. Congestive heart failure requiring pharmacological treatment 6. Clinical evidence of liver disease 7. Evidence of alcoholism or acute alcohol intoxication 8. Known hypersensitivity to metformin or any excipients associated with the preparation (in this case: Magnesium stearate, sodium carboxymethylcellulose, hypromellose) 9. Other acute conditions requiring hospital admission.

Design outcomes

Primary

Measure	Time frame
Glycaemia at 12 months as ascertained by the oral glucose tolerance test.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 20/05/2020: 1. Changes in glycaemia from baseline as ascertained by the oral glucose tolerance test at 6 and 12 months 2. Incidence of adverse events assessed using patient notes at 12 months 3. Rates of retention in care assessed using patient notes at 12 months 4. Estimated adherence to study drugs assessed using patient notes at 12 months Previous secondary outcome measures: 1. Changes in glycaemia from baseline as ascertained by the oral glucose tolerance test 2. Incidence of adverse events assessed using patient notes at 12 months 3. Rates of retention in care assessed using patient notes at 12 months 4. Estimated adherence to study drugs assessed using patient notes at 12 months	—

Measure

Time frame

Current secondary outcome measures as of 20/05/2020: 1. Changes in glycaemia from baseline as ascertained by the oral glucose tolerance test at 6 and 12 months 2. Incidence of adverse events assessed using patient notes at 12 months 3. Rates of retention in care assessed using patient notes at 12 months 4. Estimated adherence to study drugs assessed using patient notes at 12 months Previous secondary outcome measures: 1. Changes in glycaemia from baseline as ascertained by the oral glucose tolerance test 2. Incidence of adverse events assessed using patient notes at 12 months 3. Rates of retention in care assessed using patient notes at 12 months 4. Estimated adherence to study drugs assessed using patient notes at 12 months

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Countries

Tanzania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026