E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with T2DM already treated with metformin. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
|
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 |
After addition of Sitagliptin (JANUVIA®) to outpatients with T2DM who have inadequate glycemic control on metformin therapy
- To compare the efficacy of three strategies of lifestyle changes associated with JANUVIA 100 mg/d in patients with T2DM inadequately controlled by metformin (HbA1C 6.5-9%). There will be a difference between the three strategies of lifestyle changes. |
|
E.2.2 | Secondary objectives of the trial |
- To estimate the percentage of patients achieving the HbA1c target goal after 24 weeks in each intervention arm and overall - To compare the percentage of patients achieving the HbA1c target goal after 24 weeks between the 3 intervention arms - To estimate the feasibility of pedometer use - To compare the changes in blood parameters between the 3 intervention arms - To confirm the good safety and tolerability of sitagliptin.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At Visit 1 : - Man or woman aged > or equal to 18 - With type 2 diabetes and treated with the maximal tolerated dose of metformin - With documented or high likely inadequate control of diabetes (6.5-9%) - Man, postmenauposal woman or premenopausal woman that is surgically sterilized or a woman who is considered “highly unlikely to conceive” during the study due to use of an acceptable method of birth control
At Visit 2 : - Liver transaminases (ALT, AST) < or equal to 3-fold the upper limit of normal (ULN) - Creatinine clearance > 60 ml/min using the Cockcroft-Gault formula (contraindication to metformin).
|
|
E.4 | Principal exclusion criteria |
At Visit 1 : - Known hypersensitivity or contraindication to metformin - Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis - Known hypersensitivity to one of the inactive ingredients of sitagliptin tablet - Pregnant or lactating women. - Treatment with any other investigational drug within the last 8 weeks. - Any known contra-indication to physical exercise (walking) according to the investigator - Patient who is known HIV positive - Any medication which is contra-indicated with metformin (according to the current summary characteristics of the product).
At Visit 2 : - Any oral glucose-lowering agent other than metformin or change in the metformin dose since the blood sample withdrawn for central laboratory determination. - Insulin injection since the blood sample for central laboratory determination. - Patients treated with immunosuppressive/immunomodulating agents |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 355 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 355 |
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 | Information not present in EudraCT |
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
| |
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
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 | 2 |