Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Type 1 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00447382

Purpose

This trial is conducted in Europe and Africa.

This trial aims for a comparison of the safety of insulin detemir produced by a new process with insulin detemir produced by the current process. Safety will be measured by formation of antibodies in subjects with type 1 diabetes.

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

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin aspart Insulin Detemir Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
Official Title:	Safety of Insulin Detemir Produced by a New Process Versus Insulin Detemir Produced by the Current Process in Subjects With Type 1 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change of insulin antibodies [ Time Frame: From baseline to week 52 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Hypoglycaemic episodes [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]
Glycaemic control parameters [ Time Frame: during the trial ] [ Designated as safety issue: No ]
Antibodies [ Time Frame: measured during the trial ] [ Designated as safety issue: Yes ]
Clinical laboratory values [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	April 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: insulin detemir NN304 injected s.c. Given as basal insulin. Drug: insulin aspart Injected s.c. Given as bolus insulin.
B: Experimental	Drug: insulin aspart Injected s.c. Given as bolus insulin. Drug: insulin detemir NN729 injected s.c. Given as basal insulin

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
Basal-bolus treatment for at least 3 months
Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
HbA1c lesser than or equal to 12.0%

Exclusion Criteria:

Known or suspected allergy to trial products or related products
Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
Receipt of any trial drug within 1 month prior to this trial
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447382

Locations

Germany, EK Uni Frankfurt

Frankfurt, EK Uni Frankfurt, Germany, 60590
Macedonia, The Former Yugoslav Republic of

Skopje, Macedonia, The Former Yugoslav Republic of
Russian Federation

Moscow, Russian Federation
Serbia

Belgrade, Serbia, 11000
South Africa

Cape Town, South Africa

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Karsten Lyby, M.Sc.

Novo Nordisk

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:	EX1729-1778, EudraCT No: 2006-004733-15
Study First Received:	March 13, 2007
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00447382
Health Authority:	Russia: Federal Service for Control of Health Care and Social Developme; South Africa: Medicines Control Council; Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Serbia: Medicines and Medical Devices Agency of Serbia

Study placed in the following topic categories:

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

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin
Immunoglobulins

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009