Comparing Efficacy of Levemir on Blood Glucose Control Between Two Treatment Regimens in Subjects With Type 2 Diabetes in Korea - Full Text View

Purpose

This trial is conducted in Asia.

This trial aims for a comparison of the effect on glycaemic control in subjects with type 2 diabetes under both established Western algorithm and Korean practical algorithm, given in combination with oral diabetic drug(s).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin detemir	Phase IV

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin Detemir Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Comparing Efficacy of Levemir on Glycaemic Control Between Two Treatment Regimens in Subjects With Type 2 Diabetes in Korea

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of hypoglycaemic episodes and adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Change in HbA1c and FPG [ Time Frame: at 12 and 20 weeks ] [ Designated as safety issue: No ]
Proportion of subjects achieving HbA1c less than 7.0% [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	152
Study Start Date:	November 2007
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: insulin detemir Treat-to-target dose titration scheme, defined by Korean practice, once daily, injected s.c.
B: Active Comparator	Drug: insulin detemir Treat-to-target dose titration scheme, defined by Western practice, once daily, injected s.c.

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 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 BP greater than 180mmHg and/or diastolic BP less than 110mmHg)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455858

Locations


Korea, Republic of

	Seoul, Korea, Republic of

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	So Ra Lee, M.D., Ph.D.	Novo Nordisk Pharma Korea Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1762
First Received:	April 3, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00455858
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00455858