Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00117780

Purpose

This trial is conducted in Europe.

The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin detemir Drug: insulin aspart	Phase IV

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Mean HbA1c [ Time Frame: after 4 months of insulin detemir treatment ]

Secondary Outcome Measures:

HbA1c
Adverse events
Insulin dose requirements during initial 4 months of treatment and during 3 months extension
Weight
Blood glucose
Hypoglycaemia

Estimated Enrollment:	750
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes for more than 1 year
Subject treated by any kind of insulin regimen and whatever the number of injections
HbA1c = 7.5% and = 10%

Exclusion Criteria:

Type 2 diabetes
Treatment by oral anti-diabetic drugs
Severe medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117780

Locations

Belgium

Aalst, Belgium
France

Lille, France
Luxembourg

Luxembourg, Luxembourg

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Agnes Champigneulle, MD, PhD

Novo Nordisk Pharmaceutique SAS

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Le Floch JP, Lévy M, Mosnier-Pudar H, Nobels F, Laroche S, Gonbert S, Eschwege E, Fontaine P; Assessment of Detemir Administration in Progressive Treat-to-Target Trial (ADAPT) Study Group. Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT). Diabetes Care. 2009 Jan;32(1):32-7. Epub 2008 Oct 22.

Study ID Numbers:	NN304-1708, 2005-001522-88
Study First Received:	June 30, 2005
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00117780
Health Authority:	France: Afssaps - French Health Products Safety Agency; Luxembourg: Direction de la Santé: Division de la Pharmacie et des Médicaments; Belgium:

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009