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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: June 30, 2005
Last updated: June 26, 2012
Last verified: June 2012
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 Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin detemir
Drug: insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean HbA1c [ Time Frame: after 4 months of insulin detemir treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Insulin dose requirements during initial 4 months of treatment and during 3 months extension [ Designated as safety issue: No ]
  • Weight [ Designated as safety issue: No ]
  • Blood glucose [ Designated as safety issue: No ]
  • Hypoglycaemia [ Designated as safety issue: Yes ]

Enrollment: 520
Study Start Date: June 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00117780

Aalst, Belgium
Lille, France
Luxembourg, Luxembourg
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Agnes Champigneulle, MD, PhD Novo Nordisk Pharmaceutique SAS
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00117780     History of Changes
Other Study ID Numbers: NN304-1708, 2005-001522-88
Study First Received: June 30, 2005
Last Updated: June 26, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Luxembourg: Direction de la Santé: Division de la Pharmacie et des Médicaments

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin Aspart
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on December 01, 2015