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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00592527
First received: January 2, 2008
Last updated: January 26, 2017
Last verified: January 2017
  Purpose

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: No masking
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)
  Eligibility

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592527

Locations
India
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
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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
ClinicalTrials.gov 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
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017