Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01399645 | Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes | PHASE2 | COMPLETED | 35 | — | — | May 1, 2011 | Jun 1, 2014 | Aug 27, 2014 | 1 | Canada |
Improvement in liver steatosis defined by change in liver fat fraction as measured by MRI and MR spectroscopy at baseline and 12 weeks of treatment.
| Arm | Type | Description |
|---|---|---|
| Liraglutide-Metformin | EXPERIMENTAL | Liraglutide (Victoza, Novo Nordisk) at a dose of 0.6 - 1.8 mg subcutaneous per day until the end of the study. All subjects will be given metformin with a starting dose of 500 mg in one tablet twice daily given before or during meals for the duration of the study. |
| Insulin-Metformin | EXPERIMENTAL | Insulin glargine (Lantus, Sanofi-Aventis) with an initial bedtime starting dose of 10 IU. The patients will be taught to increase their insulin dose by 1 unit each day until achieving an FPG ≤ 7.0 mmol/L. All subjects will be given metformin with a starting dose of 500 mg in one tablet twice daily given before or during meals for the duration of the study. |
| Name | Type | Description |
|---|---|---|
| Liraglutide-metformin vs insulin-metformin | DRUG | Liraglutide (Victoza, Novo Nordisk) at a dose of 0.6 - 1.8 mg subcutaneous per day. Insulin glargine (Lantus, Sanofi-Aventis) with an initial bedtime starting dose of 10 IU. |
Inclusion Criteria: * Are 18 y.o. or older at screening (first visit), * Are ambulatory, * Are known for type 2 diabetes with criteria of failure of metformin monotherapy, metformin-sulfonylurea, metformin-repaglinide combined therapy defined as HbA1C ≥6.5, * Abdominal girth \> 94 cm for men and \>...