Lantus in the Treatment of Type 1 Diabetes Children | RxWiki

Lantus in the Treatment of Type 1 Diabetes Children

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 1 Diabetes
Intervention	Drug: Lantus and short acting analogs Vs NPH and short acting analogs
Phase	Phase 4
Sponsor	Baylor College of Medicine
Responsible Party	Baylor College of Medicine
ClinicalTrials.gov Identifier	NCT00206401
First Received	September 13, 2005
Last Updated	December 4, 2007
Last verified	December 2007

Tracking Information[ + expand ][ + ]

First Received Date	September 13, 2005
Last Updated Date	December 4, 2007
Start Date	November 2004
Estimated Primary Completion Date	October 2006
Current Primary Outcome Measures	HbA1C
Current Secondary Outcome Measures	Glucose excursions

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 1 Diabetes
Intervention	Drug: Lantus and short acting analogs Vs NPH and short acting analogs
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	60
Estimated Completion Date	October 2006
Estimated Primary Completion Date	Not Provided
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.
Gender	Both
Ages	6 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00206401
Other Study ID Numbers	16559
Has Data Monitoring Committee	Not Provided
Information Provided By	Baylor College of Medicine
Study Sponsor	Baylor College of Medicine
Collaborators	Not Provided
Investigators	Principal Investigator: Rubina Heptulla, MD Baylor College of Medicine
Verification Date	December 2007

Locations[ + expand ][ + ]