- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00206401
Lantus in the Treatment of Type 1 Diabetes Children
Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
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 diabetes (T1DM). To achieve the goals of the DCCT, a number of new insulin analogs( man-made insulins ) are now being incorporated into the management of patients with T1DM.
These insulin analogs are gaining importance with their ability to overcome the major obstacle to intensive insulin therapy, namely low blood glucose. In particular, insulin Glargine, considered a basal insulin, is being extensively used for management as an alternative to continuous insulin therapy injected into the tissue just below the skin. The major drawback to using insulin Glargine is that it has to be given as a separate injection and cannot be mixed with other insulins. This results in the undesirable administration of multiple insulin injections to a child with diabetes making the therapeutic plan more complex and adhering to the treatment plan more difficult.
In a previous study, (now accepted for publication in a leading diabetes journal, Diabetes Care), we have demonstrated, using continuous glucose monitoring system, that there is no significant difference in glucose concentrations (ie. high and low blood glucose episodes) when insulin Glargine is administered either mixed with a short-acting insulin analog or when giving it as a separate injection.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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HbA1C
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Secondary Outcome Measures
Outcome Measure |
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Glucose excursions
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kaplan W, Rodriguez LM, Smith OE, Haymond MW, Heptulla RA. Effects of mixing glargine and short-acting insulin analogs on glucose control. Diabetes Care. 2004 Nov;27(11):2739-40. doi: 10.2337/diacare.27.11.2739. No abstract available.
- Hassan K, Rodriguez LM, Johnson SE, Tadlock S, Heptulla RA. A randomized, controlled trial comparing twice-a-day insulin glargine mixed with rapid-acting insulin analogs versus standard neutral protamine Hagedorn (NPH) therapy in newly diagnosed type 1 diabetes. Pediatrics. 2008 Mar;121(3):e466-72. doi: 10.1542/peds.2007-1679. Epub 2008 Feb 25.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16559
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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