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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

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ClinicalTrials.gov Identifier: NCT00455858
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : February 23, 2010
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin detemir Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: insulin detemir Drug: insulin detemir
Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
Other Name: Levemir®



Primary Outcome Measures :
  1. Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 [ Time Frame: week 0, week 20 ]
    Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20


Secondary Outcome Measures :
  1. Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 [ Time Frame: week 0, week 12 ]
    Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline

  2. Change in Fasting Plasma Glucose (FPG) [ Time Frame: week 0, week 12, week 20 ]
    Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20

  3. Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% [ Time Frame: week 12, week 20 ]
    Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%

  4. Occurence of Hypoglycaemic Episodes [ Time Frame: weeks 0-20 ]
    Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455858


Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00455858     History of Changes
Other Study ID Numbers: NN304-1762
First Posted: April 4, 2007    Key Record Dates
Results First Posted: February 23, 2010
Last Update Posted: December 12, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs