Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

Phase 4 Completed 521 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before. The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

Timeline

Start: 2010-05
Primary completion: 2011-06
Completion: 2011-06

Publications

Results Yang W, Xu X, Liu X, Yang G, Seino Y, Andersen H, Jinnouchi H. Treat-to-target comparison between once daily biphasic insulin aspart 30 and insulin glargine in Chinese and Japanese insulin-naive subjects with type 2 diabetes. Curr Med Res Opin. 2013 Dec;29(12):1599-608. doi: 10.1185/03007995.2013.838155. Epub 2013 Sep 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	biphasic insulin aspart 30	Protein / enzyme biologic	—	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous
Background	Glimepiride	Small molecule	1 mg	Oral
Background	Glimepiride	Small molecule	2 mg	Oral
Background	Glimepiride	Small molecule	4 mg	Oral
Background	Metformin	Small molecule	250 mg	Oral
Background	Metformin	Small molecule	500 mg	Oral
Background	Metformin	Small molecule	1500 mg	Oral

Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

Summary

Timeline

Publications

Drugs

Indications