Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes

Phase 3 Completed 230 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.

Timeline

Start: 2004-08
Primary completion: 2005-08
Completion: 2005-08

Publications

Results Raskin P, Matfin G, Schwartz SL, Chaykin L, Chu PL, Braceras R, Wynne A. Addition of biphasic insulin aspart 30 to optimized metformin and pioglitazone treatment of type 2 diabetes mellitus: The ACTION Study (Achieving Control Through Insulin plus Oral ageNts). Diabetes Obes Metab. 2009 Jan;11(1):27-32. doi: 10.1111/j.1463-1326.2007.00796.x. Epub 2007 Oct 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	biphasic insulin aspart	Protein / enzyme biologic	6 iu	—
Background	Metformin	Small molecule	2500 mg	—
Background	Pioglitazone	Small molecule	30 mg	—
Background	Pioglitazone	Small molecule	45 mg	—

Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 Diabetes

Summary

Timeline

Publications

Drugs

Indications