Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
Completed · Phase 3
Conditions studied: Diabetes, Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT00313001
- Run by
- Novo Nordisk A/S
- People needed
- 373
- Starts
- 2006-04-01
- Expected to finish
- 2007-07-01
- Last updated by the study team
- 2017-01-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 2 diabetes
- HbA1C: At least 8%
- Patients that were never treated with insulin before
- Current therapy with metformin and a sulfonylurea.
You may not qualify if…
- 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
Where it is running
- Novo Nordisk Investigational Site — Plainsboro, New Jersey, United States
Full record on ClinicalTrials.gov
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