Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes

NCT00283751 | Completed Phase 3

• 1 other identifier: NN304-1373
• Study Type: interventional
• Target: 583
• Locations: 7 countries
• Sites: 96

Brief Summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to test if Insulin Detemir as add-on to current Oral Antidiabetic Drug treatment is at least as effective as Insulin Glargine as add-on to current Oral Antidiabetic Drug treatment in reducing HbA1c in patients with Type 2 Diabetes.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  after 52 weeks

Secondary Outcomes (4)

• Insulin antibodies

• Incident of hypoglycaemic episodes and adverse events

• Plasma glucose profiles

• Change in body weight

Interventions

insulin detemir DRUG

insulin glargine 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, and no previous insulin treatment
• Oral Antidiabetic Drug treatment for at least 4 months
• Body Mass Index (BMI) less than 40 kg/m2
• HbA1c 7.5-10.0%

You may not qualify if:

• Current or previous treatment with thiazolidinediones within the last 6 months
• Oral Antidiabetic Drug treatment with combination of three or more Oral Antidiabetic Drugs within the last 6 months
• Proliferative retinopathy or maculopathy
• Known hypoglycaemia unawareness

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (96)

Novo Nordisk Investigational Site

Greenbrae, California, 94904, United States

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La Mesa, California, 91942, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30318, United States

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Chicago, Illinois, 60607, United States

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Springfield, Illinois, 62711, United States

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Topeka, Kansas, 66606, United States

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Chesterfield, Missouri, 63017, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 68521, United States

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Pleasantville, New Jersey, 08232, United States

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Cleveland, Ohio, 44195, United States

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Kettering, Ohio, 45429, United States

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Philadelphia, Pennsylvania, 19140, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Dallas, Texas, 75230, 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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San Antonio, Texas, 78229, United States

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Warrenton, Virginia, 20186, United States

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Seattle, Washington, 98105, United States

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Ebreichsdorf, 2483, Austria

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Gratwein, 8112, Austria

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Graz, 8036, Austria

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Neunkirchen, 2620, Austria

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Vienna, 1030, Austria

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Vienna, A 1160, Austria

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Wolfsberg, 9400, Austria

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Bonheiden, 2820, Belgium

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Brussels, 1090, Belgium

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Edegem, 2650, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Besançon, 25030, France

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Bondy, 93143, France

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Grenoble, 38043, France

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La Rochelle, 17019, France

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Lyon, 69437, France

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Nantes, 44093, France

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Narbonne, 11108, France

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Nîmes, 30006, France

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Paris, 75475, France

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Paris, 75877, France

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Poitiers, 86000, France

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Strasbourg, 67091, France

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Toulouse, 31054, France

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Bad Kreuznach, 55545, Germany

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Bad Mergentheim, 97980, Germany

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Bad Neuenahr-Ahrweiler, 53474, Germany

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Berlin, 13355, Germany

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Dresden, 01307, Germany

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Flensburg, 24939, Germany

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Frankfurt, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Friedrichsthal, 66299, Germany

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Fürth, 93437, Germany

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Genthin, 39307, Germany

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Giessen, 35390, 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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Heidelberg, 69115, Germany

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Krefeld, 47798, Germany

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Ludwigshafen, 67059, Germany

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Marl, 45770, Germany

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München, 81925, Germany

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Neumünster, 24534, Germany

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Neuss, 41460, Germany

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Nuremberg, 90402, Germany

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Rehlingen-Siersburg, 66780, Germany

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Saarbrücken, 66121, Germany

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Saint Ingbert, 66386, Germany

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Schaafheim, 64850, Germany

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Schwabenheim, 55270, Germany

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Schwedt, 16303, Germany

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Völklingen, 66333, Germany

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Würzburg, 97072, Germany

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Dublin, DUBLIN 8, Ireland

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Dublin, Ireland

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Ayr, KA6 6DX, United Kingdom

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Barnsley, S75 2EP, United Kingdom

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Bolton, BL1 4QS, United Kingdom

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Bradford, BD9 6RJ, United Kingdom

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Church Village, CF38 1AB, 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, G42 9TY, United Kingdom

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Harrow, HA1 3UJ, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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Leicester, LE5 4PW, United Kingdom

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Livingstone, EH54 6PP, United Kingdom

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London, SE5 9RS, United Kingdom

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Newcastle, NE7 7DN, United Kingdom

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Poole, BH15 2JB, United Kingdom

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Salford, M6 8HD, United Kingdom

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Swansea, SA6 6NL, United Kingdom

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Related Publications (1)

• Rosenstock J, Davies M, Home PD, Larsen J, Koenen C, Schernthaner G. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as add-on to glucose-lowering drugs in insulin-naive people with type 2 diabetes. Diabetologia. 2008 Mar;51(3):408-16. doi: 10.1007/s00125-007-0911-x. Epub 2008 Jan 16.

  PMID: 18204830 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin Detemir; Insulin Glargine

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: January 27, 2006
• First Posted: January 30, 2006
• Study Start: March 1, 2003
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

GB (17); BE (5); AU (7); US (21); IE (2); DE (31); FR (13)