Comparison of Insulin Detemir With Insulin Glargine in Type 2 Diabetes

NCT00106366 | Completed Phase 3

• 1 other identifier: NN304-2175
• Study Type: interventional
• Target: 389
• Locations: 3 countries
• Sites: 78

Brief Summary

This trial is conducted in the United States of America (USA). The purpose of this study is to determine if the use of insulin detemir in combination with insulin aspart is safe and at least as effective as insulin glargine in combination with insulin aspart for the control of blood glucose in patients with Type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Keywords

Diabetes, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  after 26 weeks

Secondary Outcomes (2)

• Body weight

• Glucose profiles

Interventions

insulin detemir DRUG

insulin glargine DRUG

insulin aspart DRUG

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 for more than 12 months
• Currently treated with glucose lowering tablets or insulin
• HbA1c: 7.0-12.0%

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (78)

Novo Nordisk Investigational Site

Birmingham, Alabama, 35235, United States

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Vestavia Hills, Alabama, 35209, United States

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Little Rock, Arkansas, 72204, United States

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Searcy, Arkansas, 72143, United States

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Chula Vista, California, 91911, United States

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Concord, California, 94520, United States

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Inglewood, California, 90301, United States

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Los Angeles, California, 90057, United States

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Orange, California, 92868, United States

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Santa Ana, California, 92705, United States

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Santa Barbara, California, 93105, United States

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Santa Monica, California, 90404, United States

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Aurora, Colorado, 80045, United States

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Longmont, Colorado, 80501, United States

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Newark, Delaware, 19702, United States

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Aventura, Florida, 33180, United States

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Delray Beach, Florida, 33484, United States

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Lake Mary, Florida, 32746, United States

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Longwood, Florida, 32779, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32804, United States

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Plantation, Florida, 33324, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30032, United States

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Atlanta, Georgia, 30318, United States

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Powder Springs, Georgia, 30127, 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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Springfield, Illinois, 62711, United States

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Des Moines, Iowa, 50314, United States

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Topeka, Kansas, 66606, United States

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Baltimore, Maryland, 21204, United States

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Saint Paul, Minnesota, 55108, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89102, United States

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Reno, Nevada, 89502-0111, United States

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Berlin, New Jersey, 08009, United States

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Lawrenceville, New Jersey, 08648, United States

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West Seneca, New York, 14224, United States

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Asheville, North Carolina, 28801, United States

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Greensboro, North Carolina, 27408, United States

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Monroe, North Carolina, 28204, United States

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Raleigh, North Carolina, 27609, United States

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Canton, Ohio, 44718, United States

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Franklin, Ohio, 45005, United States

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Kettering, Ohio, 45429, United States

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Mentor, Ohio, 44060, United States

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Clinton, Oklahoma, 73601, United States

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Tulsa, Oklahoma, 74104, United States

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Medford, Oregon, 97504, United States

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Duncan, South Carolina, 29334, United States

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Chattanooga, Tennessee, 37404, United States

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Arlington, Texas, 76014, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75246, United States

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Dallas, Texas, 75390-8858, United States

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Houston, Texas, 77030, United States

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Midland, Texas, 79707, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78229, United States

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Newport News, Virginia, 23606, United States

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Richmond, Virginia, 23249, United States

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Richmond, Virginia, 23294, United States

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Olympia, Washington, 98502, United States

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Renton, Washington, 98057, United States

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Tacoma, Washington, 98405, United States

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Calgary, Alberta, T2H 2G4, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Toronto, Ontario, M5C 2T2, Canada

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Laval, Quebec, H7T 2P5, Canada

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London, N6A 5A5, Canada

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Mississauga, L5M 2V8, Canada

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Montreal, H3A 1A1, Canada

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Ste-Foy, G1V 4G5, Canada

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Thornhill, L4J 8L7, Canada

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Rio Piedras, 00921, Puerto Rico

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Related Publications (1)

• Raskin P, Gylvin T, Weng W, Chaykin L. Comparison of insulin detemir and insulin glargine using a basal-bolus regimen in a randomized, controlled clinical study in patients with type 2 diabetes. Diabetes Metab Res Rev. 2009 Sep;25(6):542-8. doi: 10.1002/dmrr.989.

  PMID: 19565569 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir; Insulin Glargine; Insulin Aspart

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; Insulin, Short-Acting

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2005
• First Posted: March 23, 2005
• Study Start: March 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

CA (9); PR (1); US (68)