Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily - Full Text View

Purpose

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves

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

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin Detemir Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Proportion of patients achieving HbA1c levels less than7% [ Time Frame: At 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients achieving HbA1c levels less than or equal to 6.5% [ Time Frame: At 20 weeks ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: At 20 weeks ] [ Designated as safety issue: No ]
Incidence of hypoglycaemia [ Time Frame: At 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	236
Study Start Date:	February 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: insulin detemir Treat-to-target dose titration scheme, s.c. injection, once daily. FPG titration target range of 70-90 mg/dL
B: Experimental	Drug: insulin detemir Treat-to-target dose titration scheme, s.c. injection, once daily. FPG titration target range of 80-110 mg/dL

Eligibility

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

Criteria

Inclusion Criteria:

Type 2 diabetes
1-3 oral treatments
Insulin naive
BMI less than or equal to 45

Exclusion Criteria:

Pregnancy
Retinopathy
Cardiac disease
Uncontrolled hypertension
Recurrent hypoglycaemia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634842

Show 55 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Markus J. Merilainen, 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:	NN304-3502
First Received:	March 6, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00634842
Health Authority:	United States: Institutional Review Board

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 September 23, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00634842