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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir

• Registration Number: NCT00455858
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-03
• Study First Submitted QC: 2007-04-03
• Study First Posted: 2007-04-04
• Study Start: 2007-11
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-12-16
• Results First Submitted QC: 2010-02-04
• Results First Posted: 2010-02-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
insulin detemir	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20	week 0, week 20	Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20

Secondary Outcome Measures

Name	Time	Method
Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12	week 0, week 12	Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline
Occurence of Hypoglycaemic Episodes	weeks 0-20	Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.
Change in Fasting Plasma Glucose (FPG)	week 0, week 12, week 20	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%	week 12, week 20	Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%