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.

iverpool School of Tropical Medicine0 个研究点目标入组 364 人开始时间: 2019年3月22日最近更新: 2023年8月2日

试验速览

2023 Results article in https://doi.org/10.1007/s00125-023-05968-7 (added 18/07/2023)

•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<=30 combined with either impaired fasting glucose (6.3 to 6.9 mmol/L) and/or impaired glucose tolerance at 2 hours (9.0 to 11.10 mmol/L)
•4. Planning to remain in the area for > 6-months
•5. Written informed consent

•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.

发起方

iverpool School of Tropical Medicine