Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 27, 2006
Last updated: June 19, 2012
Last verified: June 2012
This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine as Add-on to Current Oral Antidiabetic Drugs 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 52 weeks ]

Secondary Outcome Measures:
  • Insulin antibodies
  • Incident of hypoglycaemic episodes and adverse events
  • Plasma glucose profiles
  • Change in body weight

Enrollment: 583
Study Start Date: March 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 2 Diabetes for more than 12 months, and no previous insulin treatment
  • Oral Antidiabetic Drug treatment for at least 4 months
  • Body Mass Index (BMI) less than 40 kg/m2
  • HbA1c 7.5-10.0%

Exclusion Criteria:

  • Current or previous treatment with thiazolidinediones within the last 6 months
  • Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
  • Proliferative retinopathy or maculopathy
  • Known hypoglycaemia unawareness
  Contacts and Locations
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Please refer to this study by its identifier: NCT00283751

United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103
Vienna, Austria
Leuven, Belgium
Bondy, France
Heidelberg, Germany
Dublin, Ireland
United Kingdom
Leicester, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Per Clauson, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00283751     History of Changes
Other Study ID Numbers: NN304-1373 
Study First Received: January 27, 2006
Last Updated: June 19, 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Insulin Detemir
Physiological Effects of Drugs processed this record on January 19, 2017