Status:
COMPLETED
Lantus in the Treatment of Type 1 Diabetes Children
Lead Sponsor:
Baylor College of Medicine
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-25 years
Phase:
PHASE4
Brief Summary
In this study, we plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected sep...
Detailed Description
The landmark report of the diabetes control and complications trial (DCCT) trial has shown that intensive management delays and/or prevents complications in small vessels associated with Type 1 diabet...
Eligibility Criteria
Inclusion
- Age greater than 6 years of age but less than 25 years of age (Insulin glargine has been approved for use in children 6 years and older).
- Patients newly diagnosed with T1DM within the past 3 months.
- Have an HgbA1c of less than 9.0%, after the initial run-in period of 3 months.
- Have a BMI of less than the 90th percentile for age.
- Randomization of subjects willing to participate in the study.
Exclusion
- Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc) that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis.
- Lack of supportive family.
- Evidence or history of chemical abuse.
- Age less than 6 years or greater than 25 years.
- HbA1c level of greater than 9.0%, after the initial run-in period of 3 months.
- Have a BMI greater than the 90th percentile for age.
- Patients who are not newly diagnosed with T1DM.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00206401
Start Date
November 1 2004
End Date
October 1 2006
Last Update
July 14 2016
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030