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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00283751
First received: January 27, 2006
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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
Diabetes Mellitus, Type 2
Drug: insulin detemir
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin antibodies [ Designated as safety issue: No ]
  • Incident of hypoglycaemic episodes and adverse events [ Designated as safety issue: Yes ]
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]

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)
  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, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283751

Locations
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89103
Austria
Vienna, Austria
Belgium
Leuven, Belgium
France
Bondy, France
Germany
Heidelberg, Germany
Ireland
Dublin, Ireland
United Kingdom
Leicester, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Per Clauson, MD, PhD 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: NCT00283751     History of Changes
Other Study ID Numbers: NN304-1373
Study First Received: January 27, 2006
Last Updated: June 19, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Ministry for Health and Women
Ireland: Irish Medicines Board
United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on April 21, 2014