Detemir: Role in Type 1 Diabetes

This study is currently recruiting participants.

Verified by Baylor College of Medicine, November 2007

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00564395

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 IV

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Blood sugars patterns [ Time Frame: during the study ]

Estimated Enrollment:	20
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2007

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

Contacts

Contact: Thanh M Nguyen, MD, PhD	832 822 3790	thanhn@bcm.tmc.edu
Contact: Kimbery J Mason, RN, CDE	832 822 1010	kjmason@bcm.tmc.edu

Locations

United States, Texas
Texas Children's Hospital Endocrine and Diabetes Clinic	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Rubina A Heptulla, MD

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Rubina A Heptulla, MD

Baylor College of Medicine

More Information

Study ID Numbers:	H-16541
Study First Received:	November 27, 2007
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00564395
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009