E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
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 |
To study the improvement in glycaemic control, without increasing the episodes of hypoglycemia, following the addition of Glucophage® SR in addition to insulin in non-overweight patients with type-1 Diabetes. |
|
E.2.2 | Secondary objectives of the trial |
1. Improvement in episodes of hypoglycemia in Glucophage® SR arm of study. 2. Reduction in insulin dose in Glucophage® SR arm of the study. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age > 18 years. Male or Female. In addition, patients should fulfill all the following criteria at the randomization visit: 1. Type – 1 Diabetic patients with C-peptide negative result at screening visit (defined as C-peptide concentration < 0.18nmol/L at a time when blood glucose level is > 5.0mmol/L). 2. Suboptimal glycaemic control (HbA1c 7.3% to 8.3% at screening visit) with or without history of mild hypoglycemia (defined as hypoglycemia not affecting cognitive function and not requiring third party intervention for reversal). 3. History of previous attempts to improve glycaemic control resulting in hypoglycemic episodes (history from hospital medical notes or directly from patients). 4. History of Diabetes for > 1 year. 5. BMI 21 to 27. 6. Willing and able to comply with the study protocol. |
|
E.4 | Principal exclusion criteria |
1. Previous H/O: M.I. (in last 12months), 2. Congestive Cardiac Failure (NYHA class III or IV), 3. Chronic kidney disease with eGFR < 45mL/minute/1.73m2. 4. Abnormal ALT (> 3fold at baseline). 5. Hypoglycaemia symptoms unawareness 6. History of hypoglycemic episodes requiring 3rd party assistance for reversal. 7. Uncontrolled Hypertension (BP > 180/100mmHg). 8. Pregnant OR likelihood of pregnancy during the study. 9. Females who are breast feeding. 10. Proliferative Diabetic retinopathy and / or laser treatment in last 12 months. 11. History of recurrent Diabetic ketoacidosis - DKA (or DKA in last 6 months), lactic acidosis and gasteroparesis. 12. Previous or current treatment with metformin / Glucophage® SR. 13. History of irritable bowel syndrome. 14. Previous intolerance to metformin or Glucophage® SR. 15. History of weight loss in last 6 months. 16. History of allergic or hypersensitivity reaction to Glucophage® SR or any insulin. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c at the end of the study from baseline. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
Every effort will be made to end the study with the last patient last visit. If a scenario is encountered as in this question (A-70), we will seek extension from the local ethics committee and local R&D office. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 | 0 |