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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.

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00313001
First received: April 8, 2006
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart
Drug: exenatide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Biphasic Insulin Aspart 70/30 (NovoLog® Mix 70/30) vs. Exenatide (ByettaTM) in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets on Metformin and a Sulfonylurea.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Superiority as assessed by HbA1c reduction [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety variables [ Designated as safety issue: No ]
  • Patient satisfaction [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: April 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00313001

Locations
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Saginaw, Michigan, United States, 48602
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
United States, Texas
Novo Nordisk Clinical Trial Call Center
Carrollton, Texas, United States, 75007
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jason Brett, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00313001     History of Changes
Other Study ID Numbers: BIASP-1714
Study First Received: April 8, 2006
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
 Exenatide
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013