Back to resultsEffects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
biphasic insulin aspart
exenatide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Superiority as assessed by HbA1c reduction
Secondary Outcome Measures
Safety variables
Patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00313001
Brief Title
Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 receiving exenatide twice daily. Patients enrolled in the study will be insulin naive patients who have not achieved glycemic control with metformin and sulfonylurea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
373 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart
Intervention Type
Drug
Intervention Name(s)
exenatide
Primary Outcome Measure Information:
Title
Superiority as assessed by HbA1c reduction
Time Frame
at 24 weeks
Secondary Outcome Measure Information:
Title
Safety variables
Title
Patient satisfaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Plainsboro
State/Province
New Jersey
ZIP/Postal Code
08536
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19210140
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
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