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OpenTrials
Completed

NCT Number: NCT00095082

Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I 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, Helsinki, Finland

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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 treatment with basal-bolus insulin regimen for more than or equal to 3 months
  • HbA1c less than or equal to 11.0%

Exclusion criteria

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Impaired hepatic or renal function
  • Cardiac problems or uncontrolled hypertension

Treatment and study plan

insulin detemir

Drug

insulin glargine

Drug

insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 1 year trial period

Secondary outcomes

  1. Adverse events

  2. Body weight

  3. Hypoglycemia

  4. Blood glucose

  5. Insulin Treatment Satisfaction

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Nov 1, 2004
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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