Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes

NCT00104182 | Completed Phase 3

• 2 other identifiers: NN304-16322004-001461-18
• Study Type: interventional
• Target: 503
• Locations: 7 countries
• Sites: 96

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1C

  after 20 weeks

Secondary Outcomes (4)

• Adverse events

• body weight

• Hypoglycemia

• Blood glucose

Interventions

insulin detemir DRUG

insulin NPH 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
• Currently treated with Oral Antidiabetic Drugs
• BMI lesser than or equal to 40 kg/m2
• HbA1c greater than or equal 7.5 and lesser than or equal to 11%

You may not qualify if:

• Proliferative retinopathy or maculopathy
• Recurrent major hypoglycaemia
• uncontrolled hypertension or any disease or condition (such as renal, hepatic or cardiac) that according to the judgement of the Investigator makes the subject unsuitable for participation in the trial

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (96)

Novo Nordisk Investigational Site

Birmingham, Alabama, 35235, United States

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Mesa, Arizona, 85205, United States

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Phoenix, Arizona, 85029, United States

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Anaheim, California, 92801, United States

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Concord, California, 94520, United States

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Fullerton, California, 92835, United States

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La Jolla, California, 92037, 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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Poway, California, 92064, United States

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Denver, Colorado, 80220, United States

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Lake Mary, Florida, 32746, United States

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Springfield, Illinois, 62711, United States

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Fall River, Massachusetts, 02721, United States

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Waltham, Massachusetts, 02453, United States

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Jefferson City, Missouri, 65109, United States

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Las Vegas, Nevada, 89030, United States

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Lewiston, New York, 14092, United States

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Williamsville, New York, 14221, United States

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Grand Forks, North Dakota, 58201, United States

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Cincinnati, Ohio, 45291, United States

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Dayton, Ohio, 45406, United States

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Connellsville, Pennsylvania, 15425, United States

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Lancaster, Pennsylvania, 17601, United States

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Norristown, Pennsylvania, 19401, United States

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Greer, South Carolina, 29651, United States

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Conroe, Texas, 77384, United States

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Killeen, Texas, 76543, United States

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Seattle, Washington, 98105, United States

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Aalborg, 9000, Denmark

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Copenhagen, 2400, Denmark

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Esbjerg, 6700, Denmark

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Glostrup Municipality, 2600, Denmark

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Herlev, 2730, Denmark

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Hillerød, 3400, Denmark

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Hjørring, 9800, Denmark

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Horsens, 8700, Denmark

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Hvidovre, 2650, Denmark

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København S, 2300, Denmark

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Næstved, 4700, Denmark

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Roskilde, 4000, Denmark

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Bagnols-sur-Cèze, 30200, France

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Besançon, 25030, France

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Carcassonne, 11000, France

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Corbeil-Essonnes, 91106, France

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Dax, 40107, France

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Montpellier, 34295, France

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Quimper, 29107, France

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Rueil-Malmaison, 92501, France

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Tours, 37044, France

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Vénissieux, 69200, France

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Cagliari, 09134, Italy

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Catania, 95126, Italy

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Genova, 16132, Italy

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Messina, 98123, Italy

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Monza, 20052, Italy

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Napoli, 80131, Italy

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Parma, 43100, Italy

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Pescara, 65124, Italy

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Prato, 59100, Italy

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Roma, 00161, Italy

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Torino, 10126, Italy

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Treviso, 31100, Italy

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's-Hertogenbosch, 5216 GC, Netherlands

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Almelo, 7609 PP, Netherlands

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Etten-Leur, 4872 LP, Netherlands

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Roelofarendsveen, 2371 RB, Netherlands

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Rotterdam, 3082 DC, Netherlands

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The Hague, 2584 HV, Netherlands

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Vlodrop, 6063 DA, Netherlands

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Bergen, 5021, Norway

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Bergen, NO-5012, Norway

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Elverum, 2408, Norway

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Gjøvik, NO-2819, Norway

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Kongsvinger, 2212, Norway

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Oslo, 0370, Norway

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Oslo, 0586, Norway

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Stavanger, 4011, Norway

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Trondheim, NO-7030, Norway

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Alcorcón, 28922, Spain

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Almería, 04009, Spain

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Barcelona, 08017, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Bilbao, 48013, Spain

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Cadiz, 11009, Spain

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Getafe, 28905, Spain

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Gijón, 33206, Spain

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Granada, 18012, Spain

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Palma de Mallorca, 07198, Spain

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Pamplona, 31008, Spain

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Santa Cruz de Tenerife, 38010, Spain

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Santiago de Compostela, 15706, Spain

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Valencia, 46026, Spain

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Valladolid, 47010, Spain

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Valladolid, 47011, Spain

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Related Publications (1)

• Philis-Tsimikas A, Charpentier G, Clauson P, Ravn GM, Roberts VL, Thorsteinsson B. Comparison of once-daily insulin detemir with NPH insulin added to a regimen of oral antidiabetic drugs in poorly controlled type 2 diabetes. Clin Ther. 2006 Oct;28(10):1569-81. doi: 10.1016/j.clinthera.2006.10.020.

  PMID: 17157113 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir; Insulin, Isophane

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

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: February 23, 2005
• First Posted: February 24, 2005
• Study Start: February 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: January 30, 2017

Record last verified: 2017-01

Locations

IT (12); DK (12); NO (9); ES (17); FR (10); NL (7); US (29)