Detemir: Role in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00564395
First received: November 27, 2007
Last updated: September 10, 2015
Last verified: September 2015
  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 mixed with RAI injection
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:


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 ]

Enrollment: 13
Study Start Date: August 2007
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir mixed with RAI injection
One Insulin detemir mixed with RAI injection given twice daily
Drug: Insulin detemir mixed with RAI injection
Insulin detemir injection and RAI injection
Active Comparator: Insulin detemir injection and RAI injection
insulin detemir and RAI as separate injections twice daily
Drug: Insulin detemir mixed with RAI injection
Insulin detemir injection and RAI injection

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
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
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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

Responsible Party: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00564395     History of Changes
Other Study ID Numbers: H-16541 
Study First Received: November 27, 2007
Last Updated: September 10, 2015
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
Insulin, Globin Zinc
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016