At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 24 Week Randomised, Open Label, 3 Parallel-group Comparison of Once and Twice Daily Biphasic Insulin Aspart (BIAsp) 30 Plus Sitagliptin and Twice Daily BIAsp 30, All in Combination With Metformin in Insulin naïve Type 2 Diabetic Subjects Inadequately Controlled on Sitagliptin and Metformin
In Brief
A Phase 4 clinical trial evaluating biphasic insulin aspart 30, sitagliptin, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 582 participants across 69 sites in 10 countries.
Detailed Summary
This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)). The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.
Study Details
Timeline
Interventions
BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.
BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.
Subjects will continue on their pre-trial sitagliptin treatment.
Subjects will continue on their pre-trial metformin treatment.