Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

This study has been completed.

First Received: February 23, 2005 Last Updated: March 26, 2009 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00104182

Purpose

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

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, isophane Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening as Add-on to Oral Antidiabetic Drug(s) in Patients With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1C [ Time Frame: after 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Designated as safety issue: Yes ]
body weight [ Designated as safety issue: No ]
Hypoglycemia [ Designated as safety issue: Yes ]
Blood glucose [ Designated as safety issue: No ]

Estimated Enrollment:	501
Study Start Date:	February 2005

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
Currently treated with Oral Antidiabetic Drugs
BMI lesser than or equal to 40 kg/m2
HbA1c greater than or equal 7.5 and lesser than or equal to 11%

Exclusion Criteria:

Proliferative retinopathy or maculopathy
Recurrent major hypoglycaemia
uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104182

Show 31 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Per Clauson, MD, PhD

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1632, EudraCT No: 2004-001461-18
Study First Received:	February 23, 2005
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00104182 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Spain: Spanish Agency of Medicines; Denmark: Danish Medicines Agency; Netherlands: Dutch Health Care Inspectorate; Italy: The Italian Medicines Agency; Norway: Norwegian Medicines Agency; United States: Food and Drug Administration

Keywords provided by Novo Nordisk:

Diabetes Mellitus, Type II

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin, Isophane
Insulin

ClinicalTrials.gov processed this record on May 07, 2009