Lantus in the Treatment of Type 1 Diabetes Children

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Drug: Lantus and short acting analogs Vs NPH and short acting analogs	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
Study Start Date :	November 2004
Study Completion Date :	October 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. HbA1C

Secondary Outcome Measures :

1. Glucose excursions

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 25 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:	Rubina Heptulla, MD	Baylor College of Medicine

More Information

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Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sponsored Programs, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00206401 History of Changes
Other Study ID Numbers:	16559
First Posted:	September 21, 2005
Last Update Posted:	July 14, 2016
Last Verified:	July 2016

Keywords provided by Sponsored Programs, Baylor College of Medicine:

Adolescents; Lantus

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases	Autoimmune Diseases; Immune System Diseases; Insulin Glargine; Hypoglycemic Agents; Physiological Effects of Drugs