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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00104182
First received: February 23, 2005
Last updated: June 26, 2012
Last verified: June 2012
  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
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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 ]

Enrollment: 503
Study Start Date: February 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Calera, Alabama, United States, 35040
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Mesa, Arizona, United States, 85205
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85006
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Fullerton, California, United States, 92835
Novo Nordisk Clinical Trial Call Center
La Jolla, California, United States, 92037
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92123
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Wheat Ridge, Colorado, United States, 80033
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Fall River, Massachusetts, United States, 02721
Novo Nordisk Clinical Trial Call Center
Waltham, Massachusetts, United States, 02453
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Jefferson City, Missouri, United States, 65109
United States, Nevada
Novo Nordisk Clinical Trial Call Center
N. Las Vegas, Nevada, United States, 89030
United States, New York
Novo Nordisk Clinical Trial Call Center
Lewiston, New York, United States, 14092
Novo Nordisk Clinical Trial Call Center
New York, New York, United States, 10003
Novo Nordisk Clinical Trial Call Center
Williamsville, New York, United States, 14221
United States, North Dakota
Novo Nordisk Clinical Trial Call Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45229
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45406
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Connellsville, Pennsylvania, United States, 15425
Novo Nordisk Clinical Trial Call Center
Norristown, Pennsylvania, United States, 19401
Novo Nordisk Clinical Trial Call Center
Reading, Pennsylvania, United States, 19606
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
United States, Texas
Novo Nordisk Clinical Trial Call Center
Conroe, Texas, United States, 77384
Novo Nordisk Clinical Trial Call Center
Harker Heights, Texas, United States, 75648
United States, Washington
Novo Nordisk Clinical Trial Call Center
Seattle, Washington, United States, 98104
Denmark
Copenhagen, Denmark
France
Besancon, France
Italy
Catania, Italy
Netherlands
Almelo, Netherlands
Norway
Trondheim, Norway
Spain
Barcelona, Spain
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Per Clauson, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00104182     History of Changes
Other Study ID Numbers: NN304-1632, 2004-001461-18
Study First Received: February 23, 2005
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 A/S:
Diabetes Mellitus, Type II

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Insulin, NPH
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014