Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sitagliptin · 2 trials · 2 indications
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Sitagliptin is used for the treatment of diabetes, specifically type 2 diabetes mellitus. It is being studied in clinical trials to evaluate its effect on blood glucose control in patients with this condition. The drug is administered to adults aged 18 years and older.
Sitagliptin is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO. The company is conducting clinical trials to investigate the drug's efficacy and safety in patients with type 2 diabetes.
Sitagliptin is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials have been completed, and the drug is being evaluated for its ability to control blood glucose levels in patients with type 2 diabetes.
Sitagliptin has been studied in two completed Phase 3 clinical trials. The first trial, NCT00789191, enrolled 222 participants and examined the effect of Detemir and sitagliptin on blood glucose control in type 2 diabetes. The second trial, NCT01046110, enrolled 458 participants and compared NN1250 with sitagliptin in subjects with type 2 diabetes never treated with insulin.
No, sitagliptin is not the same as NN1250. In one clinical trial, NCT01046110, NN1250 was compared with sitagliptin in subjects with type 2 diabetes who had never been treated with insulin. The trial was designed to evaluate the effects of both treatments on blood glucose control.