ISRCTN77382043
Active, not recruiting
Phase 3
Preventing and delaying the development of diabetes in Africa: a randomised placebo-controlled double-blind phase III trial of metformin in people living with HIV-infection and pre-diabetes.
niversity College London0 sites2,100 target enrollmentJuly 9, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity College London
- Enrollment
- 2100
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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