Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00604253

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 type 2 diabetes when added to current OHA treatment.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir Insulin, isophane

U.S. FDA Resources

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 Insulin NPH as Add-on to Current OHA Therapy in Subjects With type2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 36 weeks of treatment ]

Secondary Outcome Measures:

Plasma glucose profiles
Incidence of hypoglycaemic episodes
Adverse events
Insulin antibodies

Estimated Enrollment:	336
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Duration of type 2 diabetes mellitus for at least one year
Insulin naive patients
OHA treatment for at least 12 weeks
HbA1C between 7.5-10.0%
Body Mass Index (BMI) below 30.0 kg/m2

Exclusion Criteria:

Impaired renal function
Impaired hepatic function
Pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604253

Locations

Japan

Tokyo, Japan, 103

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Tatsuya Sasako

Novo Nordisk Pharma 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:	NN304-1477, JAPIC: JapicCTI-R070009
Study First Received:	January 17, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00604253
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)

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, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009