Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

NCT00095082 | Completed Phase 3

• 2 other identifiers: NN304-14302004-000086-35
• Study Type: interventional
• Target: 447
• Locations: 7 countries
• Sites: 81

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type I

Outcome Measures

Primary Outcomes (1)

• HbA1c

  after 1 year trial period

Secondary Outcomes (5)

• Adverse events

• Body weight

• Hypoglycemia

• Blood glucose

• Insulin Treatment Satisfaction

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 1 diabetes for at least 12 months
• Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
• HbA1c less than or equal to 11.0%

You may not qualify if:

• Proliferative retinopathy or maculopathy
• Recurrent major hypoglycaemia
• Impaired hepatic or renal function
• Cardiac problems or uncontrolled hypertension

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (81)

Novo Nordisk Investigational Site

Anaheim, California, 92801, United States

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Novo Nordisk Investigational Site

Huntington Beach, California, 92646, United States

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Inglewood, California, 90301, United States

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Irvine, California, 92618, United States

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La Jolla, California, 92037, United States

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Hollywood, Florida, 33021, 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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Melbourne, Florida, 32901, United States

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Tampa, Florida, 33613, United States

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Vero Beach, Florida, 32960, United States

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Atlanta, Georgia, 30318, 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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Topeka, Kansas, 66606, United States

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Hyattsville, Maryland, 20782, United States

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Detroit, Michigan, 48235, United States

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St Louis, Missouri, 63110, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 89119-6100, United States

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Berlin, New Jersey, 08009, United States

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Sea Girt, New Jersey, 08750, United States

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Asheville, North Carolina, 28803, United States

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Philadelphia, Pennsylvania, 19107, United States

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Dallas, Texas, 75235, 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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San Antonio, Texas, 78229, United States

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Helsinki, 00250, Finland

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Kuopio, 70210, Finland

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Oulu, 90029, Finland

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Pori, 28500, Finland

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Vantaa, 01400, Finland

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Angers, 49033, France

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Antibes, 06600, France

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Brest, 29609, France

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Grenoble, 38043, France

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La Rochelle, 17019, France

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Mougins, 06250, France

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Toulouse, 31054, France

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Alsdorf, 52477, Germany

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Bad Kreuznach, 55545, Germany

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Dormagen, 41539, Germany

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Dresden, 01307, Germany

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Flensburg, 24939, Germany

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Friedrichsthal, 66299, Germany

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Genthin, 39307, Germany

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Hamburg, 20251, Germany

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Hamburg, 21073, Germany

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Hamburg, 22607, Germany

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Herrenberg, 71083, Germany

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Kippenheim, 77971, Germany

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Rehlingen-Siersburg, 66780, Germany

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Saint Ingbert, 66386, Germany

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Speyer, 67346, Germany

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Völklingen, 66333, Germany

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Würzburg, 97072, Germany

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Almere Stad, 1315 RA, Netherlands

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Apeldoorn, 7334 DZ, Netherlands

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Capelle aan den IJssel, 2906 ZC, Netherlands

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Dordrecht, 3318 AT, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Zoetermeer, 2725 NA, Netherlands

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Norrköping, 601 82, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 112 81, Sweden

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Stockholm, 182 88, Sweden

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Umeå, 901 85, Sweden

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Vaxjo, 351 85, Sweden

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Abergavenny, NP7 7EG, United Kingdom

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Ayr, KA6 6DX, United Kingdom

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Brighton, BN2 5BE, United Kingdom

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Bristol, BS10 5NB, United Kingdom

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Cosham, PO6 3LY, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Glasgow, G4 0SF, United Kingdom

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Livingstone, EH54 6PP, United Kingdom

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Plymouth, PL8 8DQ, United Kingdom

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Sheffield, S5 7AU, United Kingdom

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Watford, WD18 0HB, United Kingdom

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Novo Nordisk Investigational Site

Wirral, Merseyside, CH63 4JY, United Kingdom

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Related Publications (1)

• Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther. 2009 Oct;31(10):2086-97. doi: 10.1016/j.clinthera.2009.10.006.

  PMID: 19922879 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Detemir; Insulin Glargine; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune 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: October 29, 2004
• First Posted: November 1, 2004
• Study Start: September 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

NL (6); DE (17); FI (5); GB (12); FR (7); US (28); SE (6)