E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012620 |
E.1.2 | Term | Diabetes mellitus precipitated |
E.1.2 | System Organ Class | 100000004861 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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
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E.5.1.1 | 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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E.5.2 | 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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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 1 |