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OpenTrials
Completed

NCT Number: NCT00312104

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Graz, Austria

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 at least 12 months
  • Current daily insulin dose of more than 1.4 IU/kg
  • BMI lesser than or equal to 35 kg/m2
  • HbA1c greater than 7.5% and less than or equal to 12.0%
  • In Austria, age more than 19 years

Exclusion criteria

  • Proliferate retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator

Treatment and study plan

insulin detemir

Drug

insulin glargine

Drug

insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 26 weeks of treatment

Secondary outcomes

  1. Adverse events

  2. Body weight

  3. Blood glucose

  4. Hypoglycaemia

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Apr 7, 2006
Registry last updated
Jan 27, 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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