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Completed

NCT Number: NCT00184639

Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

This trial is conducted in Europe.

A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years 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

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Berlin, Germany

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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
  • Current intensified insulin treatment
  • Injection of insulin Semilente®MC at bedtime for at least 6 weeks
  • BMI maximum 32 kg/m^2
  • HbA1c > 5.5 % and < 12.0 %

Exclusion criteria

  • Current treatment with premixed insulin(s)
  • Impaired hepatic or renal function
  • Recurrent major hypoglycaemia

Treatment and study plan

insulin detemir

Drug

Primary outcomes

  1. Fasting plasma glucose

    Time frame: after 16 and 32 weeks, respectively

Secondary outcomes

  1. Adverse events

  2. HbA1c results at the end of each treatment period

  3. Blood glucose

  4. Standard Laboratory Safety Parameters

  5. 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 Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Feb 24, 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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