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Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00106366
First received: March 22, 2005
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in the United States of America (USA). The purpose of this study is to determine if the use of insulin detemir in combination with insulin aspart is safe and at least as effective as insulin glargine in combination with insulin aspart for the control of blood glucose in patients with Type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin detemir
Drug: insulin glargine
Drug: insulin aspart
 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: Efficacy and Safety Comparison of Insulin Detemir and Insulin Glargine Plus Insulin Aspart in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight [ Designated as safety issue: No ]
  • Glucose profiles [ Designated as safety issue: No ]

Enrollment: 389
Study Start Date: March 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (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 for more than 12 months
  • Currently treated with glucose lowering tablets or insulin
  • HbA1c: 7.0-12.0%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106366

  Show 72 Study Locations
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Christoph Koenen, 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: NCT00106366     History of Changes
Other Study ID Numbers: NN304-2175
Study First Received: March 22, 2005
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novo Nordisk:
Diabetes, Type 2

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 June 18, 2013