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

NCT00634842 | Completed Phase 4 Results

• 1 other identifier: NN304-3502
• Study Type: interventional
• Target: 244
• Locations: 2 countries
• Sites: 69

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%

  Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment

  week 20

Secondary Outcomes (3)

• Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%

  week 20

• Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline

  week -2, week 20

• Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)

  weeks 0-20

Study Arms (2)

FPG 70-90 mg/dL

EXPERIMENTAL

Aggressive FPG (fasting plasma glucose) titration target range group

Drug: insulin detemir

FPG 80-110 mg/dL

EXPERIMENTAL

Conventional FPG (fasting plasma glucose) titration target range group

Drug: insulin detemir

Interventions

insulin detemir 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 70-90 mg/dL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• oral treatments
• Insulin naive
• BMI (Body Mass Index) less than or equal to 45

You may not qualify if:

• Pregnancy
• Retinopathy
• Cardiac disease
• Uncontrolled hypertension
• Recurrent hypoglycaemia

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (69)

Novo Nordisk Investigational Site

Goodyear, Arizona, 85395, United States

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Scottsdale, Arizona, 85251-5638, United States

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Searcy, Arkansas, 72143, United States

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Artesia, California, 90701, United States

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Escondido, California, 92025, United States

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Fullerton, California, 92835-3404, United States

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Los Angeles, California, 90036, United States

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Los Angeles, California, 90057, United States

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Orange, California, 92869, United States

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Spring Valley, California, 91978, United States

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Walnut Creek, California, 94598, United States

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Parker, Colorado, 80138-8789, United States

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Norwalk, Connecticut, 06851, United States

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Prospect, Connecticut, 06712, United States

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Boca Raton, Florida, 33433, United States

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Clearwater, Florida, 33755-2138, United States

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Jacksonville, Florida, 32204, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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Lake Mary, Florida, 32746, United States

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Plantation, Florida, 33324, United States

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Athens, Georgia, 30606, United States

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Roswell, Georgia, 30076, United States

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Savannah, Georgia, 31406, United States

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Idaho Falls, Idaho, 83404-7596, United States

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Chicago, Illinois, 60607, United States

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Terre Haute, Indiana, 47802, United States

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Topeka, Kansas, 66606, United States

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New Orleans, Louisiana, 70121, United States

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Pikesville, Maryland, 21208-3737, United States

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Saint Paul, Minnesota, 55108, United States

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Chesterfield, Missouri, 63017-3632, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89101, United States

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Berlin, New Jersey, 08009, United States

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Camden, New Jersey, 08104, United States

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Lawrenceville, New Jersey, 08648, United States

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New York, New York, 10023, United States

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Staten Island, New York, 10301, United States

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West Seneca, New York, 14224, United States

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Shelby, North Carolina, 28152, United States

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Statesville, North Carolina, 28625, United States

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Cincinnati, Ohio, 45245, United States

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Dayton, Ohio, 45406, United States

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Dayton, Ohio, 45439, United States

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Mentor, Ohio, 44060, United States

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Oklahoma City, Oklahoma, 73103, United States

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Altoona, Pennsylvania, 16602, United States

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Norristown, Pennsylvania, 19401, United States

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Philadelphia, Pennsylvania, 19104, United States

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Spartanburg, South Carolina, 29303, United States

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Taylors, South Carolina, 29687, United States

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Chattanooga, Tennessee, 37404, United States

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Chattanooga, Tennessee, 37411, United States

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Arlington, Texas, 76014, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75390-9302, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77025, United States

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Midland, Texas, 79707, United States

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Odessa, Texas, 79761, United States

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San Antonio, Texas, 78209, United States

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Spokane, Washington, 99204-2629, United States

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Spokane, Washington, 99218, United States

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Milwaukee, Wisconsin, 53209, United States

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Caguas, 00725, Puerto Rico

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San Juan, 00921, Puerto Rico

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Trujillo Alto, 00976, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 19515182 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 10, 2017
• Results First Posted: December 22, 2009

Record last verified: 2017-01

Locations

US (66); PR (3)