Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sitagliptin · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Combination insulin glargine and sitagliptin | EXPERIMENTAL | Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \< Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \<FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food. |
| Name | Type | Description |
|---|---|---|
| Insulin Glargine | DRUG | Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL). |
| Sitagliptin | DRUG | Oral administration. 100mg film-coated tablets. |
| Metformin | DRUG | Patients continued with metformin as usual oral anti-diabetic treatment. |
Inclusion criteria: * Patients who completed the core study LANTU\_C\_02761 (NCT00751114) i.e. went through the visit 14 investigation, * HbA1c \>= 7 %, * Dose of metformin compliant with the inclusion criteria of the core study (i.e. at least 1 g/day), and maintained stable for the duration of the...
Sitagliptin is used for Diabetes Mellitus, Type 2. It is a small molecule in Phase 3 clinical development for this metabolic condition. The drug is being studied in combination with insulin glargine in patients with type 2 diabetes.
Sanofi, traded as SNY, is developing Sitagliptin. The company is conducting clinical trials for this small molecule intended to treat type 2 diabetes. Sanofi is the developer behind the investigational drug.
Sitagliptin is in Phase 3 clinical development. It is an investigational drug for type 2 diabetes and has not been approved by the FDA. One Phase 3 trial has been completed, with no active trials currently ongoing.
Sitagliptin has one completed Phase 3 trial, NCT00851903, titled "Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial." The trial enrolled 112 participants across multiple countries, including the United States, Austria, Brazil, and India.
Sitagliptin is the generic name for the drug also known as Januvia. It is being developed by Sanofi for type 2 diabetes. The drug is currently in Phase 3 clinical trials and is not yet approved.