Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes

NCT01520818 ↗

Phase 3 Completed 666 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart (BIAsp) 70 and/or BIAsp 50 with biphasic human insulin (BHI) 30 treatment.

Timeline

Start: 2000-03
Primary completion: 2001-04
Completion: 2001-04

Outcome

Met primary endpoint

paper Haemoglobin A(1c), the primary efficacy endpoint, was shown to be significantly lower for the BIAsp treatment group compared with the biphasic HI (BHI) 30 group PMID 18269638 ↗

paper [estimated mean difference: -0.32, 95% confidence interval (CI) (-0.48; -0.16), p = 0.0001]. PMID 18269638 ↗

Publications

Results Clements MR, Tits J, Kinsley BT, Rastam J, Friberg HH, Ligthelm RJ. Improved glycaemic control of thrice-daily biphasic insulin aspart compared with twice-daily biphasic human insulin; a randomized, open-label trial in patients with type 1 or type 2 diabetes. Diabetes Obes Metab. 2008 Mar;10(3):229-37. doi: 10.1111/j.1463-1326.2006.00687.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	human insulin	Protein / enzyme biologic	—	Subcutaneous
Subject	insulin aspart	Protein / enzyme biologic	—	Subcutaneous