Metformin for the prevention of diabetes among people with HIV and either impaired fasting glucose or impaired glucose tolerance (prediabetes) in Tanzania: a Phase II randomised placebo-controlled trial
Primary result · 2 h glucose after 75 g oral glucose loadResult — go to the resultMean difference 0.20 mmol/l 95% CI −0.17 to 0.58Authors' conclusion
Blood glucose decreased over time in both the metformin and placebo arms during the trial but did not differ significantly between the arms at 12 months of follow up. Metformin therapy was found to be safe for use in individuals with HIV and prediabetes. A larger trial with longer follow up is needed to establish if metformin can be safely used for the prevention of diabetes in people who have HIV.
Study context
- Population
- Adults (≥18 years) stable in HIV care with prediabetes (IFG and/or IGT), attending hospitals in Dar es Salaam, Tanzania
- Participants
- 364 adults
- Comparison
- Sustained-release metformin 2000 mg daily vs placebo
- Metforminn = 182
- Placebon = 182reference
- Primary endpoint
- Capillary blood glucose 2 h after a 75 g glucose load
- Follow-up
- 12 months
Methodological detailsPhase II, double-blind, placebo-controlled, permuted blocks, Randomised 4 November 2019 to 21 July 2020; follow-up 12 months
- Phase II
- Double-blind
- Placebo-controlled
- Permuted blocks
- Randomised 4 November 2019 to 21 July 2020; follow-up 12 months
Primary result
2 h glucose after 75 g oral glucose load
Mean difference
0.20 mmol/l
95% CI −0.17 to 0.58
By group
As reported in the abstract
Further findings
Mean, mmol/l
| Outcome | Metformin | Placebo | Mean difference (mmol/l) (95% CI) | |
|---|---|---|---|---|
| Fasting glucose · 12 monthsLinear mixed model controlling for baseline values | 6.17 (95% CI 6.03–6.30) | 6.30 (95% CI 6.18–6.42) | −0.08 (−0.37 to 0.20) | |
| −0.4−0.200.20.4Difference, mmol/l (linear scale) |
| Outcome | Mean difference (kg) (95% CI) | |
|---|---|---|
| WeightLinear mixed model adjusting for baseline | −1.47 (−2.58 to −0.35) | |
| −4−202Difference, kg (linear scale) |
Adherence: took >95% of medicines in previous 28 days · 12 months
P = 0.068
Baseline glucose · enrolment
Mean fasting glucose Metformin 6.37 mmol/l (95% CI 6.23, 6.50) · Placebo 6.26 mmol/l (95% CI 6.15, 6.36)
- Baseline glucose: value = mean 2 h glucose
Safety
Serious adverse event (DAIDS Grade 3 or 4) or death · events unrelated or unlikely related to study drugs
Original publication
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