Lantus in the Treatment of Type 1 Diabetes Children

NCT00206401 | Completed Phase 4

• 1 other identifier: 16559
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Adolescents; Lantus

Outcome Measures

Primary Outcomes (1)

• HbA1C

Secondary Outcomes (1)

• Glucose excursions

Interventions

Lantus and short acting analogs Vs NPH and short acting analogs DRUG

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 15505016 RESULT

• 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.

  PMID: 18299307 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Rubina Heptulla, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: November 1, 2004
• Study Completion: October 1, 2006
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

US (1)