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Detemir: Role in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00564395
First received: November 27, 2007
Last updated: August 23, 2010
Last verified: October 2009
History of Changes
  Purpose

We study blood sugars in the children with T1DM, who are given insulin detemir and a rapid acting insulin. We hypothesize that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Drug: insulin detemir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Detemir: Role in Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Blood sugars patterns [ Time Frame: during the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: insulin detemir
    Twice daily Detemir either mixed with Novolog or given separately
  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with antibody positive T1DM
  • On insulin glargine for at least 3 months
  • Age 10-25 years
  • Not on medications that may affect glucose concentrations
  • HbA1C of less than 9 %
  • BMI less than 95th % and more than 10th%
  • Supportive family

Exclusion Criteria:

  • Subjects with undetermined diabetes or T2DM
  • Unable to adhere to insulin regimen
  • Positive urine pregnancy test
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564395

Locations
United States, Texas
Texas Children's Hospital Endocrine and Diabetes Clinic
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Rubina A Heptulla, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Rubina Heptulla, MD, Baylor
ClinicalTrials.gov Identifier: NCT00564395     History of Changes
Other Study ID Numbers: H-16541
Study First Received: November 27, 2007
Last Updated: August 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013