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

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. Identifier: NCT00592527
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus
Study Start Date : April 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 20 weeks of treatment ]

Secondary Outcome Measures :
  1. Fasting plasma glucose (FPG)
  2. Within-subject variation
  3. Change in body weight
  4. Incidence of adverse events

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

Inclusion Criteria:

  • Type 2 diabetes for at least 12 months since diagnosis
  • Insulin naive subjects
  • OAD treatment for at least 4 months with max. two OAD treatments
  • Body mass index below 30.0 kg/m2
  • HbA1c between 7.0-11.0%

Exclusion Criteria:

  • OAD treatment with three or more OADs
  • Secondary diabetes
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
  • Uncontrolled hypertension
  • Known or suspected allergy to trial product or related products

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 identifier (NCT number): NCT00592527

Novo Nordisk Investigational Site
Kochi, Kerala, India, 682041
Novo Nordisk Investigational Site
Ahmedabad, India, 390009
Novo Nordisk Investigational Site
Chennai, India, 600-013
Novo Nordisk Investigational Site
Chennai, India, 600010
Novo Nordisk Investigational Site
Nagpur, India, 440012
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Ramachandran A, Harish K, Sundaram A, Mayur P, Sunil GS, Srishyla MV. Improved Efficacy when Insulin Detemir is added to OADs in Indian Subjects with Type 2 Diabetes. Diabetes 2006; 55 (Suppl. 1): A469 (2028-PO)

Responsible Party: Novo Nordisk A/S Identifier: NCT00592527     History of Changes
Other Study ID Numbers: NN304-1569
First Posted: January 14, 2008    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 Detemir
Hypoglycemic Agents
Physiological Effects of Drugs