Lantus in the Treatment of Type 1 Diabetes Children
Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Lantus and short acting analogs Vs NPH and short acting analogs (Drug)
Phase: Phase 4
Sponsored by: Baylor College of Medicine
Official(s) and/or principal investigator(s):
Rubina Heptulla, MD, Principal Investigator, Affiliation: Baylor College of Medicine
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 separately) or on intensive insulin management (IIM-several shots of short
acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the
short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be
used to monitor blood glucose control over a 6 month period. Twice during the course of the
study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records
blood sugar readings every 5 minutes) will be used to record all the changes in the blood
glucose levels occurring over a 72-hour period.
Official title: Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: HbA1C
Secondary outcome: Glucose excursions
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
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.
Minimum age: 6 Years.
Maximum age: 25 Years.
- 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.
- 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.
Locations and Contacts
Texas Children's Hospital, Houston, Texas 77030, United States
Starting date: November 2004
Ending date: October 2006
Last updated: December 4, 2007