A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in Chinese Inpatients With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment

NCT01486966 Phase 4 TERMINATED Results posted

This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes. The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.

Details

Lead sponsor	Novo Nordisk A/S
Phase	Phase 4
Status	TERMINATED
Enrolment	58
Start date	2011-11
Completion	2012-06

Conditions

• Diabetes
• Diabetes Mellitus, Type 2

Interventions

• insulin detemir
• insulin aspart
• insulin NPH
• human soluble insulin
• metformin

Primary outcomes

• Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment — Week 0, week 2
  Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.

Countries

China