Post-transplant Diabetes MellitusPhase 2POWEREDNCT05240274
The POWERED Study: Prophylaxis With Metformin to Prevent PTDM
A Phase 2 study testing Metformin in people with Post-transplant Diabetes Mellitus and New Onset Diabetes After Transplant, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
PrOphylaxis With mEtformin to pREvent PTDM: 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-transplant Diabetes Mellitus, New Onset Diabetes After Transplant, New Onset Diabetes After Transplantation
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2019to 30 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (male or female) undergoing renal transplantation under the care of the Barts Health NHS Trust Renal Department
- Aged 18-75 inclusively
- Willing to comply with study schedule
Who cannot join
- History of Type 1 or type 2 diabetes
- Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
- Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
- Subject with a known hypersensitivity or contraindication to Tacrolimus
- Subject with a known hypersensitivity or contraindication to Metformin
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal London Hospital, Barts Health NHS Trust
London, E1 1BB
About this study
Official title: 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
PrOphylaxis With mEtformin to pREvent PTDM: 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.
Read the detailed description
Renal transplantation is the optimal form of renal-replacement therapy in end-stage kidney disease. However, up to 30% of new renal transplants develop post-transplant diabetes mellitus (PTDM). The development of PTDM is associated with adverse graft and patient survival outcomes and represents an increased financial burden. There is an urgent clinical need to discover therapies which could decrease the risk of developing PTDM. Metformin offers a safe and cheap therapeutic option which has been demonstrated to reduce the incidence of type 2 diabetes in a high-risk non-transplant patient group. The investigators propose to study its safety and efficacy in preventing the development of PTDM.
POWERED is a single site, placebo-controlled, double- blind randomised clinical trial of metformin in patients without pre-existing diabetes mellitus who have received a new renal transplant. Eligible, consented patients are randomised to a 3 month course of either active drug or placebo within 10 days post-transplant. All patients will receive the usual standard of care for transplant patients. Clinical and laboratory data will be collected and assessed at baseline and throughout their participation in the study. The primary endpoint is the development of PTDM as defined by a positive oral glucose tolerance test (OGTT). Secondary endpoints include graft outcomes, pancreatic b-cell function and safety endpoints. The study began recruitment in January 2019 and plans to enrol 60 patients. There are no interim analyses planned.
Ethical approval was obtained from the London - Brighton and Sussex Ethics Committee (REC 18/LO/0958) prior to commencing the study. All study-related data will be used by the Sponsor in accordance with local data protection law. Results of the trial will be submitted for publication in a peer-reviewed journal.
- Conditions
- Post-transplant Diabetes Mellitus, New Onset Diabetes After Transplant, New Onset Diabetes After Transplantation, Kidney Transplant; Complications, Renal Transplantation, End Stage Renal Disease
- Being tested
- Metformin, Placebo
- Keywords
- post-transplant diabetes mellitus, new onset diabetes after transplant, renal transplant, kidney transplant, end-stage kidney disease, metformin, PTDM, NODAT
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
metformin 500mg OD for 3 months to start within 10 days post-renal transplant
PlaceboDrug
placebo 500mg OD for 3 months to start within 10 days post-renal transplant
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | metformin 500mg OD Receives: Drug: Metformin |
| Placebo | Placebo comparator | placebo 500mg OD Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of post-transplant diabetes
Positive 2 hour oral glucose tolerance test (i.e. 2 hour sugar >11.1 mol/L)
Measured: 12 months post-renal transplant
Secondary outcomes (8)
Pancreatic beta cell function
change in calculated HOMA-IR using C-peptide measurement between baseline and month 3 using
Measured: 12 months
HbA1c
HbA1c
Measured: 12 months
impaired glucose tolerance
impaired glucose tolerance as per 2 hour oral glucose tolerance test (i.e. 2 hour glucose 7.9-11.1 mmol/L)
Measured: 12 months
patient and graft survival
patient survival, kidney transplant (graft) survival
Measured: 12 months
incidence of treatment emergent adverse events
patient safety: adverse events, serious adverse events
Measured: 12 months
rejection
episodes of acute transplant rejection
Measured: 12 months
eGFR
renal transplant function
Measured: 12 months
diagnosis of PTDM in OGTT screen fails
incidence of PTDM in patients not randomised to study due to positive OGTT at screening: defined by appearance of PTDM on problem list or prescription of an anti-diabetic drug
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start25 Jan 2019
- Primary completion30 May 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplant Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single site, placebo controlled, double blind randomised clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kieran McCafferty, M.B., B.Chir, Principal investigator, Barts Health NHS Trust; Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240274
- Sponsor's protocol ID
- 203080
- Acronym
- POWERED
- Status last verified
- Nov 2021
- First submitted
- 17 Jan 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in any published article, after de-identification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05240274
- Acronym / sponsor ID
- POWERED / 203080
- Conditions
- Post-transplant Diabetes Mellitus, New Onset Diabetes After Transplant, New Onset Diabetes After Transplantation, Kidney Transplant; Complications, Renal Transplantation, End Stage Renal Disease
- Keywords
- post-transplant diabetes mellitus, new onset diabetes after transplant, renal transplant, kidney transplant, end-stage kidney disease, metformin, PTDM, NODAT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PrOphylaxis With mEtformin to pREvent PTDM: 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.
Detailed description
Renal transplantation is the optimal form of renal-replacement therapy in end-stage kidney disease. However, up to 30% of new renal transplants develop post-transplant diabetes mellitus (PTDM). The development of PTDM is associated with adverse graft and patient survival outcomes and represents an increased financial burden. There is an urgent clinical need to discover therapies which could decrease the risk of developing PTDM. Metformin offers a safe and cheap therapeutic option which has been demonstrated to reduce the incidence of type 2 diabetes in a high-risk non-transplant patient group. The investigators propose to study its safety and efficacy in preventing the development of PTDM.
POWERED is a single site, placebo-controlled, double- blind randomised clinical trial of metformin in patients without pre-existing diabetes mellitus who have received a new renal transplant. Eligible, consented patients are randomised to a 3 month course of either active drug or placebo within 10 days post-transplant. All patients will receive the usual standard of care for transplant patients. Clinical and laboratory data will be collected and assessed at baseline and throughout their participation in the study. The primary endpoint is the development of PTDM as defined by a positive oral glucose tolerance test (OGTT). Secondary endpoints include graft outcomes, pancreatic b-cell function and safety endpoints. The study began recruitment in January 2019 and plans to enrol 60 patients. There are no interim analyses planned.
Ethical approval was obtained from the London - Brighton and Sussex Ethics Committee (REC 18/LO/0958) prior to commencing the study. All study-related data will be used by the Sponsor in accordance with local data protection law. Results of the trial will be submitted for publication in a peer-reviewed journal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single site, placebo controlled, double blind randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metforminmetformin 500mg OD |
| Placebo | Placebo comparator | Drug: Placeboplacebo 500mg OD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (male or female) undergoing renal transplantation under the care of the Barts Health NHS Trust Renal Department
- Aged 18-75 inclusively
- Willing to comply with study schedule
Key exclusion criteria (6 listed)
- History of Type 1 or type 2 diabetes
- Clinically significant history of abnormal physical and/or mental health as judged by the investigator other than conditions related to chronic kidney disease
- Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug
- Subject with a known hypersensitivity or contraindication to Tacrolimus
- Subject with a known hypersensitivity or contraindication to Metformin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metforminmetformin 500mg OD for 3 months to start within 10 days post-renal transplant | Drug | Metformin |
| Placeboplacebo 500mg OD for 3 months to start within 10 days post-renal transplant | Drug | Placebo |
Primary outcome
Diagnosis of post-transplant diabetes
Time frame: 12 months post-renal transplant
Positive 2 hour oral glucose tolerance test (i.e. 2 hour sugar >11.1 mol/L)
8 secondary outcomes
Pancreatic beta cell function
Time frame: 12 months
HbA1c
Time frame: 12 months
impaired glucose tolerance
Time frame: 12 months
patient and graft survival
Time frame: 12 months
incidence of treatment emergent adverse events
Time frame: 12 months
rejection
Time frame: 12 months
eGFR
Time frame: 12 months
diagnosis of PTDM in OGTT screen fails
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in any published article, after de-identification (text, tables, figures, and appendices).
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Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Kidney Transplant Recipient
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Liver Transplant CGM
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Continuous Glucose Monitoring (CGM) After Kidney Transplantation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kieran McCafferty, M.B., B.Chir principal investigator
Barts Health NHS Trust; Queen Mary University London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Post-transplant Diabetes Mellitus and New Onset Diabetes After Transplant, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of post-transplant diabetes (time frame: 12 months post-renal transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.