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

NCT ID: NCT00634842

Last Updated: 2017-03-10

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FPG 70-90 mg/dL

Aggressive FPG (fasting plasma glucose) titration target range group

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL

FPG 80-110 mg/dL

Conventional FPG (fasting plasma glucose) titration target range group

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

Interventions

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insulin detemir

Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL

Intervention Type DRUG

insulin detemir

Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* 1-3 oral treatments
* Insulin naive
* BMI (Body Mass Index) less than or equal to 45

Exclusion Criteria

* Pregnancy
* Retinopathy
* Cardiac disease
* Uncontrolled hypertension
* Recurrent hypoglycaemia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Goodyear, Arizona, United States

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Novo Nordisk Investigational Site

Scottsdale, Arizona, United States

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Searcy, Arkansas, United States

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Artesia, California, United States

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Escondido, California, United States

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Fullerton, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Spring Valley, California, United States

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Walnut Creek, California, United States

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Parker, Colorado, United States

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Norwalk, Connecticut, United States

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Prospect, Connecticut, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Lake Mary, Florida, United States

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Plantation, Florida, United States

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Athens, Georgia, United States

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Roswell, Georgia, United States

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Savannah, Georgia, United States

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Idaho Falls, Idaho, United States

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Chicago, Illinois, United States

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Terre Haute, Indiana, United States

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Topeka, Kansas, United States

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New Orleans, Louisiana, United States

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Pikesville, Maryland, United States

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Saint Paul, Minnesota, United States

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Chesterfield, Missouri, United States

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Staten Island, New York, United States

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West Seneca, New York, United States

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Shelby, North Carolina, United States

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Statesville, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Mentor, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Altoona, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Taylors, South Carolina, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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Spokane, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Caguas, , Puerto Rico

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San Juan, , Puerto Rico

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Trujillo Alto, , Puerto Rico

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Countries

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United States Puerto Rico

References

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Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.

Reference Type RESULT
PMID: 19515182 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-3502

Identifier Type: -

Identifier Source: org_study_id

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