The POWERED Study: Prophylaxis with metformin to prevent post transplant diabetes

A single site, placebo controlled, double blind randomised clinical trial evaluating the effectiveness of metformin to prevent post-transplant diabetes in a cohort of patients undergoing renal transplantation. - The POWERED Study: Prophylaxis with metformin to prevent PTDM

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004880-11-GB

Enrollment

Registered

2018-05-23

Start date

2018-07-25

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post transplant diabetes MedDRA version: 20.0 Level: LLT Classification code 10012620 Term: Diabetes mellitus precipitated System Organ Class: 100000004861

Interventions

Trade Name: Metformin Product Name: Metformin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Metformin CAS Number: 657-24-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients (male or female) undergoing renal transplantation at the Barts Health NHS trust - Royal London Hospital 2) Aged 18-75 inclusively 3) Willing to comply with study schedule Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: 1) History of Type 1 or type 2 diabetes 2) Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease 3) Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug. 4) Subject with a known hypersensitivity to Tacrolimus 5) Subject with a known hypersensitivity to Metformin 6) Pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Will treating post transplant patients with metformin compared to placebo for 3 months lead to a long term reduction in post transplant diabetes? Defined as the presence of PTDM (defined as positive 2hr Oral Glucose Tolerance test) 1 year post transplant. ; Secondary Objective: 1) The effect of 3/12 metformin on marker of pancreatic beta cell function using the HOMA test 2) HbA1c level at 3/6/12 months 3) Patient/Graft survival 4) Safety endpoints: SAE, AE 5) Episodes of acute rejection 6) Renal function at 12 months 7) Diagnosis of impaired glucose tolerance (2-hour glucose 7.9-11.1mmol/l) ; Primary end point(s): The primary end point is the diagnosis of diabetes following a 3 month course of metformin or placebo, defined as a positive 2-hour Oral Glucose tolerance (blood sugar greater than11.1mmol/l) test at 3, 6, or 12 months post-transplant, or following an OGTT due to suspected new diabetes at other routine clinical visits ;Timepoint(s) of evaluation of this end point: This time pint may occur at pre specified clinal visits: at 3,6,12 months after the start of the study, or at other routine visits before the commencement of any anti-diabetic medications .	—

Measure

Time frame

Main Objective: Will treating post transplant patients with metformin compared to placebo for 3 months lead to a long term reduction in post transplant diabetes? Defined as the presence of PTDM (defined as positive 2hr Oral Glucose Tolerance test) 1 year post transplant. ; Secondary Objective: 1) The effect of 3/12 metformin on marker of pancreatic beta cell function using the HOMA test 2) HbA1c level at 3/6/12 months 3) Patient/Graft survival 4) Safety endpoints: SAE, AE 5) Episodes of acute rejection 6) Renal function at 12 months 7) Diagnosis of impaired glucose tolerance (2-hour glucose 7.9-11.1mmol/l) ; Primary end point(s): The primary end point is the diagnosis of diabetes following a 3 month course of metformin or placebo, defined as a positive 2-hour Oral Glucose tolerance (blood sugar greater than11.1mmol/l) test at 3, 6, or 12 months post-transplant, or following an OGTT due to suspected new diabetes at other routine clinical visits ;Timepoint(s) of evaluation of this end point: This time pint may occur at pre specified clinal visits: at 3,6,12 months after the start of the study, or at other routine visits before the commencement of any anti-diabetic medications .

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: secondary end point assessment will take place during the study visits at 3, 6 and 12 months post transplant.; Secondary end point(s): 1) The effect of 3/12 metformin on markers of pancreatic beta cell function using the HOMA test at 3,6, and 12 months 2) HbA1c level at 3,6, and12 months 3) Patient/Graft survival 4) Safety endpoints: SAEs, AEs 5) Episodes of acute rejection 6) Renal Transplant function at 12 months 7) Diagnosis of impaired glucose tolerance (as indicated by a 2-hour oral glucose tolerance test result of 7.9-11.1 mmol/L)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: secondary end point assessment will take place during the study visits at 3, 6 and 12 months post transplant.; Secondary end point(s): 1) The effect of 3/12 metformin on markers of pancreatic beta cell function using the HOMA test at 3,6, and 12 months 2) HbA1c level at 3,6, and12 months 3) Patient/Graft survival 4) Safety endpoints: SAEs, AEs 5) Episodes of acute rejection 6) Renal Transplant function at 12 months 7) Diagnosis of impaired glucose tolerance (as indicated by a 2-hour oral glucose tolerance test result of 7.9-11.1 mmol/L)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026