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Lantus in the Treatment of Type 1 Diabetes Children

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00206401
First received: September 13, 2005
Last updated: December 4, 2007
Last verified: December 2007
History of Changes
  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 Intervention Phase
Type 1 Diabetes
 Drug: Lantus and short acting analogs Vs NPH and short acting analogs
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • HbA1C

Secondary Outcome Measures:
  • Glucose excursions

Estimated Enrollment: 60
Study Start Date: November 2004
Estimated Study Completion Date: October 2006
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

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206401

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

Publications:

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

ClinicalTrials.gov Identifier: NCT00206401     History of Changes
Other Study ID Numbers: 16559
Study First Received: September 13, 2005
Last Updated: December 4, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013