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
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: 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 July 29, 2014