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

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ClinicalTrials.gov Identifier: NCT00283751
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Drug: insulin glargine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 583 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2003
Primary Completion Date : November 2004
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 52 weeks ]

Secondary Outcome Measures :
  1. Insulin antibodies
  2. Incident of hypoglycaemic episodes and adverse events
  3. Plasma glucose profiles
  4. Change in body weight


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, 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

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): NCT00283751


  Show 96 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00283751     History of Changes
Other Study ID Numbers: NN304-1373
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

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 Detemir
Hypoglycemic Agents
Physiological Effects of Drugs