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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01046110 | Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin | PHASE3 | COMPLETED | 458 | — | — | Jan 1, 2010 | Nov 1, 2010 | Mar 3, 2017 | 93 | United States, Argentina +5 |
| NCT00789191 | Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes | PHASE3 | COMPLETED | 222 | — | — | Nov 1, 2008 | Aug 1, 2009 | Mar 14, 2017 | 51 | United States, Canada +6 |
Change from baseline in HbA1c after 26 weeks of treatment
| Arm | Type | Description |
|---|---|---|
| IDeg OD | EXPERIMENTAL | - |
| DPP-IV inhibitor | EXPERIMENTAL | - |
| Comb | EXPERIMENTAL | Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment |
| Sita | ACTIVE_COMPARATOR | Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment |
| Name | Type | Description |
|---|---|---|
| insulin degludec | DRUG | Injected under the skin once daily for 26 weeks. The doses will be individually adjusted. |
| sitagliptin | DRUG | Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks |
| insulin detemir | DRUG | The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial. |
| metformin | DRUG | Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial. |
| sulphonylurea | DRUG | Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator. |
Inclusion Criteria: * Type 2 diabetes (diagnosed clinically) for at least 6 months * Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue (sulphonylurea or glinides) or pioglitazone) in any combination with unchanged dosing for at least 3 months prior to Visit 1 with...