Clinical trial NCT00206401: Lantus in the Treatment of Type 1 Diabetes Children
Official title: Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: Adolescents
Lantus
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility 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.

Primary outcomes:
measure: HbA1C
Secondary outcomes:
measure: Glucose excursions
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Rubina Heptulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.