Trial design and interventions
prediabetes and HIV
ADVERSE EVENTS, ADVERSE EVENT, EVENTS, ACQUIRED IMMUNODEFICIENCY SYNDROME
The Metformin Treatment for Africa (META) trial was a Phase II randomised placebo-controlled trial conducted among people with prediabetes and HIV who were taking ART. Neither the participants or the healthcare staff or the researchers were aware of participant allocation (i.e. the study was double-blinded). The trial was designed to evaluate the effects of metformin on blood glucose and to evaluate drug safety over a 12 month duration. The primary outcome measure was blood glucose levels measured 2 h following a 75 g glucose load as this was felt to provide a more consistently reproducible measure than fasting glucose. Secondary outcome measures included drug safety. Adverse events were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria and events Grade 3 or greater were reported as serious adverse events (SAEs) [