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Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00106366
First Posted: March 23, 2005
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 26 weeks ]

Secondary Outcome Measures:
  • Body weight
  • Glucose profiles

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106366


  Show 78 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00106366     History of Changes
Other Study ID Numbers: NN304-2175
First Submitted: March 22, 2005
First Posted: March 23, 2005
Last Update Posted: January 31, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin Aspart
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs