Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00264901

Purpose

This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Impact of a Self-Adjusted Titration Guideline in Subjects With Type 2 Diabetes Mellitus: A Treat-to-Target of the Efficacy and Safety of Levemir® (Insulin Detemir [rDNA Origin] Injection)

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Comparison of the change from baseline to end of treatment [ Time Frame: after 26 weeks in the value of laboratory-measured HbA1c between the self adjustment versus the standard of care group ]

Secondary Outcome Measures:

Spontaneously reported adverse events during the trial
Incidence of severe hypoglycaemic during the trial nocturnal (11 pm - 6 am)
FPG during the trial (central laboratory) at Visit 2 and Visit 3
Proportion of subjects achieving HbA1C <= 7.0% at Visit 2 and Visit 3
Insulin detemir doses at Visit 2 and Visit 3
Within-subject variation of before-breakfast SMPG values at Visit 2 and Visit 3

Estimated Enrollment:	5000
Study Start Date:	October 2005

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months;
BMI <= 45.0 kg/m2
Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator

Exclusion Criteria:

Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months.
Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues
Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264901

Show 1194 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Christoph Koenen, MD

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:	NN304-1720
Study First Received:	December 12, 2005
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00264901
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009