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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00313001
First received: April 8, 2006
Last updated: October 21, 2013
Last verified: October 2013

April 8, 2006
October 21, 2013
April 2006
July 2007   (final data collection date for primary outcome measure)
Superiority as assessed by HbA1c reduction [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
Superiority as assessed by HbA1C reduction at 24 weeks
Complete list of historical versions of study NCT00313001 on ClinicalTrials.gov Archive Site
  • Safety variables [ Designated as safety issue: No ]
  • Patient satisfaction [ Designated as safety issue: No ]
  • Safety variables
  • Patient satisfaction
Not Provided
Not Provided
 
Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • Drug: biphasic insulin aspart
  • Drug: exenatide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
373
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00313001
BIASP-1714
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Jason Brett, MD Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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