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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00592527
First received: January 2, 2008
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Locations
India
Chennai, India, 600-013
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: M. V. Srishyla, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013