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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View full resultsBasic Information
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COMPLETED
PHASE4
244 participants
INTERVENTIONAL
2008-02-29
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FPG 70-90 mg/dL
Aggressive FPG (fasting plasma glucose) titration target range group
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
FPG 80-110 mg/dL
Conventional FPG (fasting plasma glucose) titration target range group
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 1-3 oral treatments
* Insulin naive
* BMI (Body Mass Index) less than or equal to 45
Exclusion Criteria
* Retinopathy
* Cardiac disease
* Uncontrolled hypertension
* Recurrent hypoglycaemia
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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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
Novo Nordisk Investigational Site
Scottsdale, Arizona, United States
Novo Nordisk Investigational Site
Searcy, Arkansas, United States
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Artesia, California, United States
Novo Nordisk Investigational Site
Escondido, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
Novo Nordisk Investigational Site
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
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Terre Haute, Indiana, United States
Novo Nordisk Investigational Site
Topeka, Kansas, United States
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States
Novo Nordisk Investigational Site
Pikesville, Maryland, United States
Novo Nordisk Investigational Site
Saint Paul, Minnesota, United States
Novo Nordisk Investigational Site
Chesterfield, Missouri, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Novo Nordisk Investigational Site
Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Camden, New Jersey, United States
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Lawrenceville, New Jersey, United States
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New York, New York, 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
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Dayton, Ohio, United States
Novo Nordisk Investigational Site
Mentor, Ohio, United States
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States
Novo Nordisk Investigational Site
Altoona, Pennsylvania, United States
Novo Nordisk Investigational Site
Norristown, Pennsylvania, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Spartanburg, South Carolina, United States
Novo Nordisk Investigational Site
Taylors, South Carolina, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Chattanooga, Tennessee, United States
Novo Nordisk Investigational Site
Arlington, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
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
Novo Nordisk Investigational Site
Spokane, Washington, United States
Novo Nordisk Investigational Site
Spokane, Washington, United States
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States
Novo Nordisk Investigational Site
Caguas, , Puerto Rico
Novo Nordisk Investigational Site
San Juan, , Puerto Rico
Novo Nordisk Investigational Site
Trujillo Alto, , Puerto Rico
Countries
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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NN304-3502
Identifier Type: -
Identifier Source: org_study_id
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