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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184639
First received: September 13, 2005
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin detemir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Fasting plasma glucose [ Time Frame: after 16 and 32 weeks, respectively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]
  • HbA1c results at the end of each treatment period [ Designated as safety issue: No ]
  • Blood glucose [ Designated as safety issue: No ]
  • Standard Laboratory Safety Parameters [ Designated as safety issue: No ]
  • Hypoglycaemia [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: August 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184639

Locations
Germany
Hannover, Germany
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Martin Grundner, MD Novo Nordisk Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184639     History of Changes
Other Study ID Numbers: NN304-1630
Study First Received: September 13, 2005
Last Updated: July 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014