Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00104182
First received: February 23, 2005
Last updated: June 26, 2012
Last verified: June 2012
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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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104182
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Hide Study LocationsLocations
| 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
Investigators
| Study Director: | Per Clauson, MD, PhD | Novo Nordisk |
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:
|
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 May 23, 2013