Status:
COMPLETED
Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 receivi...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- HbA1C: At least 8%
- Patients that were never treated with insulin before
- Current therapy with metformin and a sulfonylurea.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00313001
Start Date
April 1 2006
End Date
July 1 2007
Last Update
January 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536