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Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes (ADAPT)

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. Identifier: NCT00117780
Recruitment Status : Completed
First Posted : July 8, 2005
Last Update Posted : June 2, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection compared to insulin detemir twice daily injection administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight and side effects).

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin aspart Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Insulin Detemir Once or Twice Daily in a Basal-Bolus Regimen With Insulin Aspart in Patients With Type 1 Diabetes
Study Start Date : June 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. Mean HbA1c [ Time Frame: after 4 months of insulin detemir treatment ]

Secondary Outcome Measures :
  1. HbA1c
  2. Adverse events
  3. Insulin dose requirements during initial 4 months of treatment and during 3 months extension
  4. Weight
  5. Blood glucose
  6. Hypoglycaemia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes for more than 1 year
  • Subject treated by any kind of insulin regimen and whatever the number of injections
  • HbA1c = 7.5% and = 10%

Exclusion Criteria:

  • Type 2 diabetes
  • Treatment by oral anti-diabetic drugs
  • Severe medical conditions

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 identifier (NCT number): NCT00117780

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Novo Nordisk Investigational Site
Aalst, Belgium, 9300
Novo Nordisk Investigational Site
Lille, France, 59037
Novo Nordisk Investigational Site
Luxembourg, Luxembourg, 2763
Sponsors and Collaborators
Novo Nordisk A/S
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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 Identifier: NCT00117780    
Other Study ID Numbers: NN304-1708
2005-001522-88 ( EudraCT Number )
First Posted: July 8, 2005    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 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, Globin Zinc
Insulin Aspart
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs