Lantus in the Treatment of Type 1 Diabetes Children

Condition(s) targeted: Type 1 Diabetes

Intervention: Lantus and short acting analogs Vs NPH and short acting analogs (Drug)

Phase: Phase 4

Status: Completed

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

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.

Minimum age: 6 Years. Maximum age: 25 Years. Gender(s): Both.

Criteria:

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.

Texas Children's Hospital, Houston, Texas 77030, United States

Starting date: November 2004
Ending date: October 2006
Last updated: December 4, 2007