Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00095082
First received: October 29, 2004
Last updated: June 19, 2012
Last verified: June 2012
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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 Diabetes Mellitus, Type 1 |
Drug: insulin detemir Drug: insulin glargine Drug: insulin aspart |
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 Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes |
Resource links provided by NLM:
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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Hide Study LocationsLocations
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Anaheim, California, United States, 92801 | |
| Novo Nordisk Clinical Trial Call Center | |
| Huntington Beach, California, United States, 92646 | |
| Novo Nordisk Clinical Trial Call Center | |
| Inglewood, California, United States, 90301 | |
| Novo Nordisk Clinical Trial Call Center | |
| Irvine, California, United States, 92618 | |
| Novo Nordisk Clinical Trial Call Center | |
| La Jolla, California, United States, 92037 | |
| Novo Nordisk Clinical Trial Call Center | |
| San Diego, California, United States, 92123 | |
| Novo Nordisk Clinical Trial Call Center | |
| San Francisco, California, United States, 94143-0728 | |
| United States, Florida | |
| Novo Nordisk Clinical Trial Call Center | |
| Hollywood, Florida, United States, 33021 | |
| Novo Nordisk Clinical Trial Call Center | |
| Melbourne, Florida, United States, 32901 | |
| Novo Nordisk Clinical Trial Call Center | |
| Tampa, Florida, United States, 33607 | |
| Novo Nordisk Clinical Trial Call Center | |
| Vero Beach, Florida, United States, 32960 | |
| Novo Nordisk Clinical Trial Call Center | |
| Winter Park, Florida, United States, 32789 | |
| 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 | |
| Berlin, New Jersey, United States, 08009 | |
| Novo Nordisk Clinical Trial Call Center | |
| Brick, New Jersey, United States, 08724 | |
| 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 | |
| Houston, Texas, United States, 77030 | |
| Novo Nordisk Clinical Trial Call Center | |
| San Antonio, Texas, United States, 78237 | |
| 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:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00095082 History of Changes |
| Other Study ID Numbers: | NN304-1430, 2004-000086-35 |
| Study First Received: | October 29, 2004 |
| Last Updated: | June 19, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin aspart Glargine Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013