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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00592527
First received: January 2, 2008
Last updated: June 19, 2012
Last verified: June 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting plasma glucose (FPG) [ Designated as safety issue: No ]
  • Within-subject variation [ Designated as safety issue: No ]
  • Change in body weight [ Designated as safety issue: No ]
  • Incidence of adverse events [ Designated as safety issue: Yes ]

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
Genders Eligible for Study:   Both
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
Chennai, India, 600-013
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: M. V. Srishyla, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: June 19, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014