Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00097877
First received: November 30, 2004
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

This trial is conducted in the United States of America (USA). The purpose of this study is to test whether Biphasic Insulin Aspart 70/30 twice a day with Metformin improves glycemic control vs. once daily Insulin Glargine with Metformin in subjects with Type 2 Diabetes who are inadequately controlled on basal insulin plus oral anti-diabetic therapy.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: insulin glargine
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: Comparison of the Effect on Glycemic Control of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Combination With Metformin in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: After 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety variables [ Designated as safety issue: No ]
  • 8-point plasma glucose profile [ Designated as safety issue: No ]
  • other glycemic variables [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: January 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097877

  Show 62 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Rogelio Braceras, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00097877     History of Changes
Other Study ID Numbers: BIASP-2191
Study First Received: November 30, 2004
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novo Nordisk A/S:
Type 2 Diabetes

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

ClinicalTrials.gov processed this record on April 17, 2014