Safety and Efficacy of Insulin Detemir in Combination With OADs in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00592527

Purpose

This trial is conducted in Asia.

The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Insulin Detemir in Combination With OADs in Type 2 Diabetes Mellitus

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:

Fasting plasma glucose (FPG) [ Designated as safety issue: No ]
Within-subject variation [ Designated as safety issue: No ]
Change in body weight [ Designated as safety issue: No ]
Incidence of adverse events [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes for at least 12 months since diagnosis
Insulin naive subjects
OAD treatment for at least 4 months with max. two OAD treatments
Body mass index below 30.0 kg/m2
HbA1c between 7.0-11.0%

Exclusion Criteria:

OAD treatment with three or more OADs
Secondary diabetes
Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
Uncontrolled hypertension
Known or suspected allergy to trial product or related products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592527

Locations

India

Chennai, India, 600-013

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

M. V. Srishyla, MD

Novo Nordisk

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:	NN304-1569
Study First Received:	January 2, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00592527
Health Authority:	India: Ministry of Health

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 January 16, 2009