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Completed

NCT Number: NCT00117780

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

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).

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

insulin aspart

Drug

Primary outcomes

  1. Mean HbA1c

    Time frame: after 4 months of insulin detemir treatment

Secondary outcomes

  1. HbA1c

  2. Adverse events

  3. Insulin dose requirements during initial 4 months of treatment and during 3 months extension

  4. Weight

  5. Blood glucose

  6. Hypoglycaemia

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Acronym: ADAPT

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 8, 2005
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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