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The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00521690
First received: August 27, 2007
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

The trial is conducted in Asia. The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.


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: Safety and Therapeutic Effect of Insulin Detemir in Taiwanese Patients With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets With OAD With/Without Once-daily NPH Insulin Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Incidence of serious adverse events, including major hypoglycaemic events [ Time Frame: during 16 weeks of insulin detemir therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in HbA1C [ Time Frame: after 16 weeks ] [ Designated as safety issue: No ]
  • Change in weight [ Designated as safety issue: No ]
  • Change in fasting plasma glucose (FPG) [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: December 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • HbA1C: 7.0-11.0%
  • Previous diabetes treatment for at least 6 months
  • BMI max. 35 kg/m2
  • Treatment with an oral anti-diabetic drug (OAD)

Exclusion Criteria:

  • Type 1 diabetes
  • Receipt of any investigational drug within the last three months prior to this trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521690

Locations
Taiwan
Taipei, Taiwan, 100
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jessie Wu, MSc Novo Nordisk Pharma Ltd.
  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: NCT00521690     History of Changes
Other Study ID Numbers: NN304-1764
Study First Received: August 27, 2007
Last Updated: June 26, 2012
Health Authority: Taiwan: Department 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 21, 2013