Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes
ADAPT
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
2 other identifiers
interventional
520
3 countries
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes
Started Jun 2005
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedJune 2, 2017
May 1, 2017
1.3 years
June 30, 2005
June 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean HbA1c
after 4 months of insulin detemir treatment
Secondary Outcomes (6)
HbA1c
Adverse events
Insulin dose requirements during initial 4 months of treatment and during 3 months extension
Weight
Blood glucose
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- Type 2 diabetes
- Treatment by oral anti-diabetic drugs
- Severe medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (3)
Novo Nordisk Investigational Site
Aalst, 9300, Belgium
Novo Nordisk Investigational Site
Lille, 59037, France
Novo Nordisk Investigational Site
Luxembourg, 2763, Luxembourg
Related Publications (1)
Le Floch JP, Levy 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.
PMID: 18945928RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 8, 2005
Study Start
June 1, 2005
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
June 2, 2017
Record last verified: 2017-05