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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00117780
First received: June 30, 2005
Last updated: June 1, 2017
Last verified: May 2017
  Purpose
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 Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin aspart Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • HbA1c
  • Adverse events
  • Insulin dose requirements during initial 4 months of treatment and during 3 months extension
  • Weight
  • Blood glucose
  • Hypoglycaemia

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)
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117780

Locations
Belgium
Novo Nordisk Investigational Site
Aalst, Belgium, 9300
France
Novo Nordisk Investigational Site
Lille, France, 59037
Luxembourg
Novo Nordisk Investigational Site
Luxembourg, Luxembourg, 2763
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00117780     History of Changes
Other Study ID Numbers: NN304-1708
2005-001522-88 ( EudraCT Number )
Study First Received: June 30, 2005
Last Updated: June 1, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017