drugset / Trial / NCT00669864

Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

NCT00669864 ↗

Phase 4 Completed 293 enrolled Novo Nordisk A/S
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

Timeline

Start
2007-11
Primary completion
2009-04
Completion
2009-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); BIAsp 30-30; p <0.0001; Estimated mean -1.303 (95% CI -1.414 to -1.192); t-test, 1 sided; NCT00669864 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 1000 mg Oral
Subject Metformin Small molecule 2000 mg Oral
Subject biphasic insulin aspart 30 Protein / enzyme biologic — Subcutaneous