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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: August 27, 2007
Last updated: June 26, 2012
Last verified: June 2012

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 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:

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

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)

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

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 identifier: NCT00521690

Taipei, Taiwan, 100
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Jessie Wu, MSc Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S 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, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 15, 2014