drugset / Trial / NCT00789191

Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

NCT00789191 ↗

Phase 3 Completed 222 enrolled Novo Nordisk A/S
RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.

Timeline

Start
2008-11
Primary completion
2009-08
Completion
2009-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Comb vs Sita; p = 0.0010; Mean Difference (Final Values) -0.55 (95% CI -0.77 to -0.33) NCT00789191 ↗

paper Significantly higher reductions in HbA1c, FPG and SMPG were achieved with IDet + SITA + MET compared with SITA + MET ± SU. PMID 21205123 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin detemir Protein / enzyme biologic — Subcutaneous
Background Metformin Small molecule 1000 mg —
Background Sitagliptin Small molecule 100 mg —