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

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ClinicalTrials.gov Identifier: NCT00184639
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : August 16, 2004
Primary Completion Date : November 22, 2005
Study Completion Date : November 22, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Primary Outcome Measures :
  1. Fasting plasma glucose [ Time Frame: after 16 and 32 weeks, respectively ]

Secondary Outcome Measures :
  1. Adverse events
  2. HbA1c results at the end of each treatment period
  3. Blood glucose
  4. Standard Laboratory Safety Parameters
  5. Hypoglycaemia

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184639

Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Hannover, Germany, 30173
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184639     History of Changes
Other Study ID Numbers: NN304-1630
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs