Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in the United States of America (USA). The study will compare A1C reduction achieved in patients receiving biphasic insulin aspart 70/30 once or twice daily to patients receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Exenatide; Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin, Globin Zinc; Insulin, Long-Acting; Metformin

Criteria

Inclusion Criteria:

• Type 2 diabetes

• HbA1C: At least 8%

• Patients that were never treated with insulin before

• Current therapy with metformin and a sulfonylurea.

Exclusion Criteria:

• History of recurrent, severe hypoglycemia

• Hepatic insufficiency: ALT, AST or alkaline phosphatase > 2.5 times upper limits of laboratory's normal

• Renal insufficiency: serum creatinine > 1.3 mg/dL (males) or > 1.2 mg/dL (females)

• Severe gastrointestinal disease, including gastroparesis