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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014