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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
insulin detemir
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Mean HbA1c

Secondary Outcome Measures

HbA1c
Adverse events
Insulin dose requirements during initial 4 months of treatment and during 3 months extension
Weight
Blood glucose
Hypoglycaemia

Full Information

First Posted
June 30, 2005
Last Updated
June 1, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00117780
Brief Title
Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes
Acronym
ADAPT
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 Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
Mean HbA1c
Time Frame
after 4 months of insulin detemir treatment
Secondary Outcome Measure Information:
Title
HbA1c
Title
Adverse events
Title
Insulin dose requirements during initial 4 months of treatment and during 3 months extension
Title
Weight
Title
Blood glucose
Title
Hypoglycaemia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Luxembourg
ZIP/Postal Code
2763
Country
Luxembourg

12. IPD Sharing Statement

Citations:
PubMed Identifier
18945928
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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