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

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 8, 2005
Last Update Posted Date June 2, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2007)
Mean HbA1c [ Time Frame: after 4 months of insulin detemir treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
Mean HbA1c after 4 months of insulin detemir treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2007)
  • HbA1c
  • Adverse events
  • Insulin dose requirements during initial 4 months of treatment and during 3 months extension
  • Weight
  • Blood glucose
  • Hypoglycaemia
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
  • Blood glucose
  • HbA1c
  • Hypoglycaemia
  • Weight
  • Adverse events
  • Insulin dose requirements during initial 4 months of treatment and during 3 months extension
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: insulin detemir
  • Drug: insulin aspart
Study Arms  ICMJE Not Provided
Publications * Le Floch JP, Lévy M, Mosnier-Pudar H, Nobels F, Laroche S, Gonbert S, Eschwege E, Fontaine P; Assessment of Detemir Administration in Progressive Treat-to-Target Trial (ADAPT) Study Group. Comparison of once- versus twice-daily administration of insulin detemir, used with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes: assessment of detemir administration in a progressive treat-to-target trial (ADAPT). Diabetes Care. 2009 Jan;32(1):32-7. doi: 10.2337/dc08-0332. Epub 2008 Oct 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2009)
520
Original Enrollment  ICMJE
 (submitted: June 30, 2005)
750
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Luxembourg
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00117780
Other Study ID Numbers  ICMJE NN304-1708
2005-001522-88 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP