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POWERED: Metformin for PTDM Prevention
NCT05240274Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2019
- Primary completion
- May 2022
- Countries
- 1
- Sponsor
- Barts Health NHS Trust
- Modality
- Small Molecules
- Drugs
- metformin
- Conditions
- post-transplant diabetes mellitus (PTDM)
01
Overview
Phase 2, randomised, double-blind trial in post-transplant diabetes mellitus (PTDM) comparing Metformin with Placebo (2 arms). Primary endpoint: Diagnosis of post-transplant diabetes at 12 months. Started Jan 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Metformin
Metformin 500mg OD
Placebo
Placebo 500mg OD
03
Who it enrols
Patients undergoing renal transplantation without a history of Type 1 or Type 2 diabetes.
04
Endpoints
Primary
Diagnosis of post-transplant diabetes
Secondary
Pancreatic beta cell function
HbA1c
Impaired glucose tolerance
Patient and graft survival
Incidence of treatment emergent adverse events
Rejection
eGFR
Diagnosis of PTDM in OGTT screen fails
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