Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00455858
First received: April 3, 2007
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.


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: A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 [ Time Frame: week 0, week 20 ] [ Designated as safety issue: No ]
    Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20


Secondary Outcome Measures:
  • Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
    Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline

  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: week 0, week 12, week 20 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20

  • Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% [ Time Frame: week 12, week 20 ] [ Designated as safety issue: No ]
    Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%

  • Occurence of Hypoglycaemic Episodes [ Time Frame: weeks 0-20 ] [ Designated as safety issue: Yes ]
    Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.


Enrollment: 87
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: insulin detemir Drug: insulin detemir
Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
Other Name: Levemir®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes (diagnosed more than 12 months ago)
  • HbA1c greater than 7.0 and less than 12.0% at screening
  • Currently on any OAD in more than 3 months ago
  • BMI (Body Mass Index) less than 35kg/m2

Exclusion Criteria:

  • Previous treatment with insulin in more than 7 days within the last 3 months
  • Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455858

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: So Ra Lee, M.D., Ph.D. Novo Nordisk Pharma Korea Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00455858     History of Changes
Other Study ID Numbers: NN304-1762
Study First Received: April 3, 2007
Results First Received: December 16, 2009
Last Updated: June 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on April 17, 2014