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Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604396
First Posted: January 30, 2008
Last Update Posted: January 27, 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 Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Insulin Detemir Combined With OAD Versus Insulin NPH Combined With OAD in Type 2 Mellitus

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Fasting plasma glucose
  • Within-subject variation
  • Incidence of total hypoglycaemic episodes
  • Body weight
  • Incidence of adverse events
  • Insulin antibodies

Enrollment: 477
Study Start Date: March 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (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 at least 12 months since diagnosis
  • Insulin naive subjects
  • OAD treatment for at least 4 months alone or combined with no more than two OADs
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-10.0%
  • Able and willing to use twice a day injections for the entire trial period

Exclusion Criteria:

  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 6 months
  • Acute insulin treatment for longer than 7 days in a row within the last 6 months
  • Secondary diabetes
  • Known maturity onset of diabetes of young (MODY)
  • Known or suspected allergy to trial product or related products
  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): NCT00604396


  Show 62 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: NCT00604396     History of Changes
Other Study ID Numbers: NN304-1530
First Submitted: January 17, 2008
First Posted: January 30, 2008
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
Isophane insulin, beef
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs