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.

First Received on October 29, 2004. Last Updated on June 26, 2009 History of Changes

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 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human 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

Show 32 Study Locations

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:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00095082 History of Changes
Other Study ID Numbers:	NN304-1430, EudraCT No: 2004-000086-35
Study First Received:	October 29, 2004
Last Updated:	June 26, 2009
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:

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 21, 2012