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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 2, 2008
Last updated: January 26, 2017
Last verified: January 2017

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

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

Secondary Outcome Measures:
  • Fasting plasma glucose (FPG)
  • Within-subject variation
  • Change in body weight
  • Incidence of adverse events

Enrollment: 132
Study Start Date: April 2004
Study Completion Date: December 2004
Primary Completion Date: December 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 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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
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
Study First Received: January 2, 2008
Last Updated: January 26, 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 processed this record on September 21, 2017