Metformin treatment for diabetes prevention in Africa

Phase 3

• Conditions: Prediabetes, HIV-infection; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN77382043
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-09
• Last Update Posted: 29 April 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2100

Inclusion Criteria

Current participant inclusion criteria as of 12/12/2022:
1. Adult HIV-positive persons on antiretroviral therapy (ART) for at least 6 months and considered stable on treatment (i.e. in regular attendance for care). Considered by the clinical team to be in routine care with a plasma viral load of less than 1000 copies per ml taken within the last 12 months.
2. Either impaired fasting glucose (=6.1 to =6.9 mmol/L) and/or impaired glucose tolerance at 2 hours (=7.8 to <11.10 mmol/L)
3. Planning to remain in the area for > 12 months
4. Written informed consent

Previous participant inclusion criteria:
1. HIV-positive and stable on the same antiretroviral therapy for at least 6-months
2. Attending the HIV clinic regularly for at least 6 months
3. Impaired fasting glucose of between 6.1 to 6.9 mmol/L and/or impaired glucose tolerance at 2 hours of 7.8 to 11.10 mmol/L
4. Planning to remain in the area for > 1 year
5. Willing to provide written informed consent

Exclusion Criteria

Current participant exclusion criteria as of 12/12/2022:
1. Pregnant women
2. Patients who were participants of the META Phase II study
3. Renal disease or renal dysfunction (eGFR<45)
4. Signs and symptoms of any form of acute metabolic acidosis including lactic acidosis and diabetic ketoacidosis
5. Other acute conditions with:
5.1. The potential to alter renal function including dehydration, severe infection or shock
5.2. The potential to cause tissue hypoxia including decompensated heart failure, respiratory failure, recent myocardial infarction, shock
6. Congestive heart failure requiring pharmacological treatment
7. Clinical evidence of liver disease
8. Evidence of alcoholism or acute alcohol intoxication
9. Known hypersensitivity to metformin or any excipients associated with the preparation (in this case: Magnesium stearate, sodium carboxymethylcellulose, hypromellose)
10. Other acute conditions requiring hospital admission or emergency clinical intervention, including blood pressure >180/110 mmHg, haemoglobin<6.5g/dL for women or haemoglobin <7.0g/dL for men (grade 3); white cell count <1.5 x 109 cells/mm3(grade 3) and any baseline liver function derangements at grade 4 according to DAIDS criteria.

Previous participant 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified