Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes - Full Text View

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00095082

Purpose

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin detemir Drug: insulin glargine Drug: insulin aspart	Phase III

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 Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin glargine Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 1 year trial period ] [ 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 ]
Insulin Treatment Satisfaction [ Designated as safety issue: No ]

Enrollment:	447
Study Start Date:	September 2004
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Type 1 diabetes for at least 12 months
Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
HbA1c less than or equal to 11.0%

Exclusion Criteria:

Proliferative retinopathy or maculopathy
Recurrent major hypoglycaemia
Impaired hepatic or renal function
Cardiac problems or uncontrolled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095082

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Locations

United States, California
Novo Nordisk Clinical Trial Call Center
Inglewood, California, United States, 90301
Novo Nordisk Clinical Trial Call Center
San Francisco, California, United States, 94143-0728
Novo Nordisk Clinical Trial Call Center
Irvine, California, United States, 92618
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92123
Novo Nordisk Clinical Trial Call Center
Huntington Beach, California, United States, 92646
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
United States, Florida
Novo Nordisk Clinical Trial Call Center
Vero Beach, Florida, United States, 32960
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33607
Novo Nordisk Clinical Trial Call Center
Hollywood, Florida, United States, 33021
Novo Nordisk Clinical Trial Call Center
Winter Park, Florida, United States, 32789
Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32901
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30339
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60607
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48235
United States, Missouri
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63017
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68131
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Brick, New Jersey, United States, 08724
Novo Nordisk Clinical Trial Call Center
Berlin, New Jersey, United States, 08009
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, United States, 28801
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78237
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030
Finland

Kuopio, Finland
France

La Rochelle, France
Germany

Hamburg, Germany
Netherlands

Zoetermeer, Netherlands
Sweden

Stockholm, Sweden

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:	NN304-1430, EudraCT No: 2004-000086-35
Study First Received:	October 29, 2004
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00095082 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Finland: Finnish Medicines Agency; Netherlands: Dutch Health Care Inspectorate; Sweden: Medical Products Agency; United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novo Nordisk:

Diabetes Mellitus, Type I

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Insulin

Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Glargine
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009