Efficacy and Safety of Insulin Detemir in Type 1 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00595374

Purpose

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

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

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:	Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma glucose profiles [ Designated as safety issue: No ]
Change in body weight [ Designated as safety issue: No ]
Quality of Life [ Designated as safety issue: No ]
Incidence of adverse events [ Designated as safety issue: No ]
Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Duration of type 1 diabetes for at least 12 months
BMI below 35 kg/m2
HbA1c between 7.0-12.0%
Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria:

Known or suspected allergy to trial product or related products
Previous participation in this trial
Receipt of any investigational products within the last 2 months prior to this trial
Drug or alcohol dependence
Pregnancy, breast-feeding or intention of becoming pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595374

Locations

Netherlands

Zwolle, Netherlands, 8025 AB

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Helene Philippo, MSc

Novo Nordisk B.V.

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:	NN304-1582
Study First Received:	January 7, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00595374
Health Authority:	Netherlands: Dutch Health Care Inspectorate

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 16, 2009