Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

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 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.

Timeline

Start

2005-01

Primary completion

2006-11

Completion

2006-11

Publications

• Results Ligthelm RJ, Gylvin T, DeLuzio T, Raskin P. A comparison of twice-daily biphasic insulin aspart 70/30 and once-daily insulin glargine in persons with type 2 diabetes mellitus inadequately controlled on basal insulin and oral therapy: a randomized, open-label study. Endocr Pract. 2011 Jan-Feb;17(1):41-50. doi: 10.4158/EP10079.OR.
• Results Oyer DS, Shepherd MD, Coulter FC, Bhargava A, Deluzio AJ, Chu PL, Trippe BS; Initiateplus Study Group. Efficacy and tolerability of self-titrated biphasic insulin aspart 70/30 in patients aged >65 years with type 2 diabetes: an exploratory post hoc subanalysis of the INITIATEplus trial. Clin Ther. 2011 Jul;33(7):874-83. doi: 10.1016/j.clinthera.2011.05.093. Epub 2011 Jul 8.
• Results Trippe BS, Shepherd MD, Coulter FC, Bhargava A, Brett J, Chu PL, Oyer DS. Efficacy and safety of biphasic insulin aspart 70/30 in type 2 diabetes patients of different race or ethnicity (INITIATEplus trial). Curr Med Res Opin. 2012 Jul;28(7):1203-11. doi: 10.1185/03007995.2012.686444. Epub 2012 Jun 25.
• Bergenstal R, Lewin A, Bailey T, Chang D, Gylvin T, Roberts V; NovoLog Mix-vs.-Exenatide Study Group. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea. Curr Med Res Opin. 2009 Jan;25(1):65-75. doi: 10.1185/03007990802597951.

Drugs

Indications