Lantus in the Treatment of Type 1 Diabetes Children
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ClinicalTrials.gov Identifier: NCT00206401 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : July 14, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Drug: Lantus and short acting analogs Vs NPH and short acting analogs | Phase 4 |
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 (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 |

- HbA1C
- Glucose excursions

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206401
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Rubina Heptulla, MD | Baylor College of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sponsored Programs, Principal Investigator, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00206401 |
Other Study ID Numbers: |
16559 |
First Posted: | September 21, 2005 Key Record Dates |
Last Update Posted: | July 14, 2016 |
Last Verified: | July 2016 |
Adolescents Lantus |
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 |