Efficacy and the Safety of Insulin Detemir in Insulin Requiring Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00604344

Purpose

This trial is conducted in Japan.

The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Insulin-Dependent	Drug: insulin detemir Drug: insulin NPH	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin Detemir Insulin, isophane

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Efficacy and the Safety of Insulin Detemir and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	357
Study Start Date:	April 2003

Eligibility

Criteria

Inclusion Criteria:

Duration of diabetes mellitus for at least 2 years
Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
HbA1C below 11.0%

Exclusion Criteria:

Impaired renal function
Impaired hepatic function
Serious heart diseases
Known hypoglycaemia unawareness or recurrent major hypoglycaemia
Proliferative retinopathy or maculopathy requiring acute treatment
Uncontrolled treated/untreated hypertension
Current treatment with total insulin dose of more than 100 IU/day
Current treatment or expected at the screening to start treatment with systemic corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604344

Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Hiroko Terano	Novo Nordisk Pharma Ltd.
Study Director:	Hiroaki Arai	Novo Nordisk Pharma Ltd.

More Information

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

Study ID Numbers:	NN304-1476, JAPIC: JapicCTI-R070008
Study First Received:	January 17, 2008
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00604344
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009