We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detemir: Role in Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564395
First Posted: November 28, 2007
Last Update Posted: September 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Baylor College of Medicine
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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): 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
First Submitted: November 27, 2007
First Posted: November 28, 2007
Last Update Posted: September 14, 2015
Last Verified: September 2015

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