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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455858
• Other study ID #: NN304-1762
• Status: Completed
• Phase: Phase 4
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12	Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline	week 0, week 12
Secondary	Change in Fasting Plasma Glucose (FPG)	Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20	week 0, week 12, week 20
Secondary	Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0%	Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0%	week 12, week 20
Secondary	Occurence of Hypoglycaemic Episodes	Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment.	weeks 0-20

External Links

•   Clinical Trials at Novo Nordisk