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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 17, 2008
Last updated: June 19, 2012
Last verified: June 2012

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 Mellitus, Type 2
Drug: insulin detemir
Drug: insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

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 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
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Please refer to this study by its identifier: NCT00604396

Arlon, Belgium, 6700
Rijeka, Croatia, 51 000
Hvidovre, Denmark, 2650
Nanterre, France, 92014
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Elverum, Norway, 2408
Krakow, Poland, 31-261
Russian Federation
Moscow, Russian Federation, 117036
Trencin, Slovakia, 91171
Trelleborg, Sweden, 231 85
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Jens Larsen Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00604396     History of Changes
Other Study ID Numbers: NN304-1530 
Study First Received: January 17, 2008
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
Isophane insulin, beef
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on January 19, 2017