Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00097084

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 2 diabetes.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin glargine 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 Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

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 ]

Estimated Enrollment:	300
Study Start Date:	September 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
Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
BMI of maximum 40 kg/m2
HbA1c greater than or equal to 7.0% and 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: NCT00097084

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Locations

United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72204
United States, California
Novo Nordisk Clinical Trial Call Center
Santa Ana, California, United States, 92705
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
Spring Valley, California, United States, 91978
United States, Florida
Novo Nordisk Clinical Trial Call Center
Melbourne, Florida, United States, 32901
Novo Nordisk Clinical Trial Call Center
Orlando, Florida, United States, 32804
Novo Nordisk Clinical Trial Call Center
Vero Beach, Florida, United States, 32960
Novo Nordisk Clinical Trial Call Center
New Port Richey, Florida, United States, 34652
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32205
Novo Nordisk Clinical Trial Call Center
Winter Park, Florida, United States, 32789
Novo Nordisk Clinical Trial Call Center
Boca Raton, Florida, United States, 33433
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Athens, Georgia, United States, 30606
United States, Idaho
Novo Nordisk Clinical Trial Call Center
Idaho Falls, Idaho, United States, 83404
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
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
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
Novo Nordisk Clinical Trial Call Center
Hermitage, Pennsylvania, United States, 16148
United States, Texas
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78237
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23249
Novo Nordisk Clinical Trial Call Center
Norfolk, Virginia, United States, 23462
United States, Washington
Novo Nordisk Clinical Trial Call Center
Tacoma, Washington, United States, 98405
Finland

Espoo, Finland
France

Venissieux, France
Norway

Sarpsborg, Norway
Sweden

Lund, 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:	NN304-1431, EudraCT No: 2004-000087-27
Study First Received:	November 17, 2004
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00097084 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Norway: Norwegian Medicines Agency; Sweden: Medical Products 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
Insulin, Asp(B28)-
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 14, 2009