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A Multi-centre, Randomised, Open-labelled, 2-sequence, 2-period Crossover Trial to Investigate the Efficacy and Safety of Biphasic Insulin Aspart 50 (BIAsp 50) Twice Daily Versus Biphasic Human Insulin 50 (BHI 50) Twice Daily Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of biphasic insulin aspart 50 (BIAsp 50) twice daily versus biphasic human insulin 50 (BHI 50) twice daily, both in combination with metformin, in Chinese subjects with type 2 diabetes mellitus.
Details
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 161 |
| Start date | 2013-06 |
| Completion | 2014-05 |
Conditions
- Diabetes
- Diabetes Mellitus, Type 2
Interventions
- biphasic insulin aspart 50
- biphasic human insulin 50
Primary outcomes
- 2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test — After 4 weeks of treatment in each treatment sequence
The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.
Countries
China