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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effects of NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) BID and QD vs. Byetta™ Exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets With Metformin and a Sulfonylurea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313001
• Other study ID #: BIASP-1714
• Status: Completed
• Phase: Phase 3
• First received: April 8, 2006
• Last updated: January 5, 2017
• Start date: April 2006
• Est. completion date: July 2007

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart

• exenatide

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Plainsboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 metformi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority as assessed by HbA1c reduction		at 24 weeks	No
Secondary	Safety variables			No
Secondary	Patient satisfaction			No

External Links

•   Clinical Trials at Novo Nordisk