Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

NCT00097084 | Completed Phase 3

• 2 other identifiers: NN304-14312004-000087-27
• Study Type: interventional
• Target: 324
• Locations: 5 countries
• Sites: 60

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 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

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 2 diabetes for at least 12 months
• Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
• BMI of maximum 40 kg/m2
• HbA1c greater than or equal to 7.0% and 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 (60)

Novo Nordisk Investigational Site

Little Rock, Arkansas, 72204, United States

Location

Novo Nordisk Investigational Site

Inglewood, California, 90301, United States

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Novo Nordisk Investigational Site

San Francisco, California, 94143-0780, United States

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Novo Nordisk Investigational Site

Santa Ana, California, 92705, United States

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Novo Nordisk Investigational Site

Spring Valley, California, 91978, United States

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Novo Nordisk Investigational Site

Boca Raton, Florida, 33433, United States

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Novo Nordisk Investigational Site

Jacksonville, Florida, 32216, United States

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Novo Nordisk Investigational Site

Lake Mary, Florida, 32746, United States

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Novo Nordisk Investigational Site

Melbourne, Florida, 32901, United States

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Novo Nordisk Investigational Site

Orlando, Florida, 32804, United States

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Novo Nordisk Investigational Site

Palm Harbor, Florida, 34684, United States

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Novo Nordisk Investigational Site

Vero Beach, Florida, 32960, United States

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Novo Nordisk Investigational Site

Athens, Georgia, 30606, United States

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Novo Nordisk Investigational Site

Idaho Falls, Idaho, 83404-7596, United States

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Novo Nordisk Investigational Site

Topeka, Kansas, 66606, United States

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Novo Nordisk Investigational Site

Omaha, Nebraska, 68114, United States

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Novo Nordisk Investigational Site

Las Vegas, Nevada, 89119-6100, United States

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Novo Nordisk Investigational Site

Berlin, New Jersey, 08009, United States

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Novo Nordisk Investigational Site

Asheville, North Carolina, 28803, United States

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Novo Nordisk Investigational Site

Hermitage, Pennsylvania, 16148, United States

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Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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Novo Nordisk Investigational Site

Dallas, Texas, 75235, United States

Location

Novo Nordisk Investigational Site

Dallas, Texas, 75246, United States

Location

Novo Nordisk Investigational Site

Dallas, Texas, 75390-8858, United States

Location

Novo Nordisk Investigational Site

San Antonio, Texas, 78229, United States

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Novo Nordisk Investigational Site

Newport News, Virginia, 23606, United States

Location

Novo Nordisk Investigational Site

Richmond, Virginia, 23249, United States

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Novo Nordisk Investigational Site

Tacoma, Washington, 98405, United States

Location

Novo Nordisk Investigational Site

Espoo, 02740, Finland

Location

Novo Nordisk Investigational Site

Helsinki, 00260, Finland

Location

Novo Nordisk Investigational Site

Kurikka, FI-61300, Finland

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Novo Nordisk Investigational Site

Lahti, FI-15110, Finland

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Novo Nordisk Investigational Site

Lapua, FI-62100, Finland

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Novo Nordisk Investigational Site

Oulu, FI-90220, Finland

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Novo Nordisk Investigational Site

Turku, 20700, Finland

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Novo Nordisk Investigational Site

Brest, 29200, France

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Novo Nordisk Investigational Site

Le Mans, France

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Novo Nordisk Investigational Site

Montpellier, 34295, France

Location

Novo Nordisk Investigational Site

Nanterre, 92014, France

Location

Novo Nordisk Investigational Site

Narbonne, 11108, France

Location

Novo Nordisk Investigational Site

Nevers, 58033, France

Location

Novo Nordisk Investigational Site

Orléans, France

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Novo Nordisk Investigational Site

Paris, 75181, France

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Novo Nordisk Investigational Site

Vénissieux, 69200, France

Location

Novo Nordisk Investigational Site

Bergen, NO-5009, Norway

Location

Novo Nordisk Investigational Site

Notodden, NO-3675, Norway

Location

Novo Nordisk Investigational Site

Sarpsborg, 1723, Norway

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Novo Nordisk Investigational Site

Ski, NO-1400, Norway

Location

Novo Nordisk Investigational Site

Stavanger, 4011, Norway

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Novo Nordisk Investigational Site

Trondheim, NO-7030, Norway

Location

Novo Nordisk Investigational Site

Ängelholm, 262 91, Sweden

Location

Novo Nordisk Investigational Site

Falun, 791 82, Sweden

Location

Novo Nordisk Investigational Site

Gothenburg, 417 17, Sweden

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Novo Nordisk Investigational Site

Kalmar, 391 85, Sweden

Location

Novo Nordisk Investigational Site

Lund, 221 85, Sweden

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Novo Nordisk Investigational Site

Lund, 223 70, Sweden

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Novo Nordisk Investigational Site

Malmo, 214 26, Sweden

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Novo Nordisk Investigational Site

Motala, 591 85, Sweden

Location

Novo Nordisk Investigational Site

Oskarshamn, 572 28, Sweden

Location

Novo Nordisk Investigational Site

Uddevalla, 451 50, Sweden

Location

Related Publications (1)

• Hollander P, Cooper J, Bregnhoj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.

  PMID: 19108786 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: November 17, 2004
• First Posted: November 18, 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

NO (6); SE (10); US (28); FR (9); FI (7)