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
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
1 other identifier
interventional
87
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes
Started Nov 2007
Shorter than P25 for phase_4 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
February 23, 2010
CompletedFebruary 1, 2024
January 1, 2024
11 months
April 3, 2007
December 16, 2009
January 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20
week 0, week 20
Secondary Outcomes (4)
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12
week 0, week 12
Change in Fasting Plasma Glucose (FPG)
week 0, week 12, week 20
Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%
week 12, week 20
Occurence of Hypoglycaemic Episodes
weeks 0-20
Study Arms (1)
insulin detemir
ACTIVE COMPARATORInterventions
Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Seoul, South Korea
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Public Access to Clinical Trials
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2007
First Posted
April 4, 2007
Study Start
November 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
February 1, 2024
Results First Posted
February 23, 2010
Record last verified: 2024-01