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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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ClinicalTrials.gov Identifier: NCT00313001
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 8, 2006
First Posted Date  ICMJE April 11, 2006
Last Update Posted Date January 6, 2017
Study Start Date  ICMJE April 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2007)
Superiority as assessed by HbA1c reduction [ Time Frame: at 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2006)
Superiority as assessed by HbA1C reduction at 24 weeks
Change History Complete list of historical versions of study NCT00313001 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2007)
  • Safety variables
  • Patient satisfaction
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2006)
  • Patient satisfaction
  • Safety variables
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: biphasic insulin aspart
  • Drug: exenatide
Study Arms  ICMJE Not Provided
Publications * 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 .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2009)
373
Original Enrollment  ICMJE
 (submitted: April 8, 2006)
540
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313001
Other Study ID Numbers  ICMJE BIASP-1714
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP