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Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00312104
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin glargine Drug: insulin aspart Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.
Study Start Date : April 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 26 weeks of treatment ]

Secondary Outcome Measures :
  1. Adverse events
  2. Body weight
  3. Blood glucose
  4. Hypoglycaemia


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months
  • Current daily insulin dose of more than 1.4 IU/kg
  • BMI lesser than or equal to 35 kg/m2
  • HbA1c greater than 7.5% and less than or equal to 12.0%
  • In Austria, age more than 19 years

Exclusion Criteria:

  • Proliferate retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312104


Locations
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Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Wien, Austria, 1030
Novo Nordisk Investigational Site
Wien, Austria, 1090
Novo Nordisk Investigational Site
Wien, Austria, A 1160
Novo Nordisk Investigational Site
Wien, Austria, A-1130
Germany
Novo Nordisk Investigational Site
Bad Kreuznach, Germany, 55545
Novo Nordisk Investigational Site
Bad Mergentheim, Germany, 97980
Novo Nordisk Investigational Site
Bad Neuenahr-Ahrweiler, Germany, 53474
Novo Nordisk Investigational Site
Berlin, Germany, 10789
Novo Nordisk Investigational Site
Diez, Germany, 65582
Novo Nordisk Investigational Site
Erlangen, Germany, 91052
Novo Nordisk Investigational Site
Essen, Germany, 45138
Novo Nordisk Investigational Site
Flensburg, Germany, 24939
Novo Nordisk Investigational Site
Frankfurt, Germany, 60590
Novo Nordisk Investigational Site
Friedrichsthal, Germany, 66299
Novo Nordisk Investigational Site
Genthin, Germany, 39307
Novo Nordisk Investigational Site
Halle, Germany, 06120
Novo Nordisk Investigational Site
Hamburg, Germany, 20251
Novo Nordisk Investigational Site
Hannover, Germany, 30171
Novo Nordisk Investigational Site
Heidelberg, Germany, 69115
Novo Nordisk Investigational Site
Hennigsdorf, Germany, 16761
Novo Nordisk Investigational Site
Hünxe, Germany, 46569
Novo Nordisk Investigational Site
Jena, Germany, 07743
Novo Nordisk Investigational Site
Kiel, Germany, 24105
Novo Nordisk Investigational Site
Landau, Germany, 76829
Novo Nordisk Investigational Site
Ludwigshafen, Germany, 67059
Novo Nordisk Investigational Site
Marl, Germany, 45770
Novo Nordisk Investigational Site
Mönchengladbach, Germany, 41061
Novo Nordisk Investigational Site
Neunkirchen, Germany, 66538
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Novo Nordisk Investigational Site
Northeim, Germany, 37154
Novo Nordisk Investigational Site
Nürnberg, Germany, 90402
Novo Nordisk Investigational Site
Rehlingen-Siersburg, Germany, 66780
Novo Nordisk Investigational Site
Rheda-Wiedenbrück, Germany, 33378
Novo Nordisk Investigational Site
Saarbrücken, Germany, 66121
Novo Nordisk Investigational Site
Saarlouis, Germany, 66740
Novo Nordisk Investigational Site
Schwabenheim, Germany, 55270
Novo Nordisk Investigational Site
Schwerin, Germany, 19049
Novo Nordisk Investigational Site
Schönebeck, Germany, 39218
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Novo Nordisk Investigational Site
Wiesbaden, Germany, 65183
Novo Nordisk Investigational Site
Würzburg, Germany, 97072
South Africa
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4091
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7130
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00312104    
Other Study ID Numbers: NN304-1372
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Aspart
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs