Comparison of Insulin Detemir and NPH Insulin in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily. The Pediatric Mixing Trial. - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00542620

Purpose

This trial is conducted in Europe. The aim of the study is to compare two methods of injection in basal-bolus insulin regimen in type 1 diabetic children with insulin detemir associated with insulin aspart given twice daily in either separate or mixed injections and to investigate if there is any clinical impact in choosing one regimen over another.

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

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin Detemir Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	To Assess if Using Insulin Detemir Mixed With Insulin Aspart Versus 2 Separate Injections Will Have Any Clinical Impact in the Glycemic Control Assessed by HbA1C.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Continuous Glucose Monitoring System (CGMS) [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]
Self Measured Plasma Glucose (SMPG) [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]
Fructosamine [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]
Plasma glucose profiles [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]
Pharmacokinetics [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]
Paper Diary [ Time Frame: after two months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: insulin detemir Treat-to-target dose titration, s.c. injection, twice a day, either mixed with insulin aspart or injected separately Drug: insulin aspart Treat-to-target dose titration, s.c. injection, twice a day, either mixed with insulin detemir or injected separately
B: Active Comparator	Drug: insulin detemir Treat-to-target dose titration, s.c. injection, twice a day, either mixed with insulin aspart or injected separately Drug: insulin aspart Treat-to-target dose titration, s.c. injection, twice a day, either mixed with insulin detemir or injected separately

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Parents' Informed Consent obtained before any trial-related activities.
Obtained child's assent (when possible)
Type 1 diabetes
Treatment with insulin detemir and insulin aspart either in extemporaneous mixed or separate injections
HbA1c lesser than or equal to 8.6%

Exclusion Criteria:

History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol
Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone)
Any other condition that the Investigator feels would interfere with trial participation or evaluation of results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542620

Locations

France

Paris, France

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Bertrand Alexandre

Novo Nordisk Pharmaceutique S.A.S.

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1813, EudraCT No: 2006-006715-77
Study First Received:	October 10, 2007
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00542620
Health Authority:	France: Afssaps - French Health Products Safety Agency

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, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009