Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00537303

Purpose

This trial is conducted in Europe, Africa and the USA. The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment, in type 2 diabetes

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin detemir Drug: insulin aspart	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Efficacy and Safety of Step-Wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-Diabetic Treatment in Patients With Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

HbA1c [ Time Frame: after 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Hypoglycaemic episodes [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]
Biochemistry [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
Haematology [ Time Frame: For the duration of the trial ] [ Designated as safety issue: No ]
CV risk markers [ Time Frame: For the duration of the trial ] [ Designated as safety issue: Yes ]

Enrollment:	345
Study Start Date:	October 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: insulin detemir Treat-to-target dose titration scheme, injection s.c. Drug: insulin aspart Administered 1 - 3 times daily, at largest prancial increment, injection s.c.
B: Active Comparator	Drug: insulin detemir Treat-to-target dose titration scheme, injection s.c. Drug: insulin aspart Administered 1 - 3 times daily, at largest meals, injection s.c.

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus for more than 6 months
HbA1c between 7,5 % and 10.0% at trial initiation (screening)
BMI less than 40 kg/m2

Exclusion Criteria:

Known or suspected allergy to trial products or related products
Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
Previous participation in any trial including this for the last 6 months
Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537303

Show 32 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Berit Gorsoe Kjeldsen, MSc

Novo Nordisk

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1833, EudraCT No: 2007-000123-18
Study First Received:	September 28, 2007
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00537303 History of Changes
Health Authority:	Russia: Pharmacological Committee, Ministry of Health; South Africa: Medicines Control Council; Spain: Spanish Agency for Medicines; Sweden: Medical Products Agency; Serbia: Medicines and Medical Devices Agency of Serbia; United Kingdom: Medicines and Healthcare Products Regulatory; United States: Food and Drug Administration; Norway: Norwegian Medicines Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 11, 2009