Metformin treatment in Africa- META
A randomised placebo-controlled double-blind phase III trial to determine the effects of metformin versus placebo on the incidence of diabetes in HIV-infected persons with pre-diabetes in Tanzania
The aim of the META trial is to identify a low-cost intervention for preventing and delaying the development of diabetes among HIV-infected persons on antiretroviral therapy (ART) with pre diabetes in Africa.
META Phase III
The main objectives are:
- In partnership between researchers, policy makers, health care providers and patient representatives, conduct a phase III randomised double-blind trial of metformin versus placebo among HIV-infected persons with pre-diabetes in Africa.
- Develop research capacity in clinical studies of diabetes, hypertension and other chronic conditions in HIV infection.
2000 patients will be randomised, selected from those who have been on ART for at least 6 months. The primary endpoint of the trial will be incidence of (type 2) diabetes over a 36-month period of follow up. Secondary outcomes will include cost consequences, health-related quality-of-life, and cost-effectiveness.
This will be the largest trial of its kind in Africa and it will generate evidence that will be of global relevance. In ancillary studies we will compare diagnostic methods for diabetes in HIV-infected persons. These and various clinical data will be used to enhance capacity development opportunities.