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

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Novo Nordisk

Status and phase

Completed
Phase 4

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Drug: insulin aspart
Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00117780
NN304-1708
2005-001522-88 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

520 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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