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View Clinical Trial (Medical Research Study)
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6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes - NCT00993473-08807 (Clinical Trial 368728)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy368728.aspx
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| City: |
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Bridgewater |
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State:
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NJ |
| Zip Code: |
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08807 |
| Conditions: |
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Type 1 Diabetes Mellitus |
| Purpose: |
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The primary study objective is to compare the rate of "all hypoglycemia" between children
treated with insulin glargine and Neutral Protamine Hagedorn (NPH) insulin.
Secondary objectives are to compare insulin glargine and NPH in terms of:
- rates of specific types of hypoglycemia: symptomatic, severe, nocturnal, nocturnal
symptomatic, and severe nocturnal symptomatic hypoglycemia
- HbA1c change from baseline to end-of-treatment, and HbA1c at end-of-treatment
- percentage of patients reaching HbA1 less than 7.5% (target value) at end-of-treatment
- average blood glucose over whole trial and at end of trial, as estimated by continuous
glucose monitoring (CGM)
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| Study summary: |
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Screening phase: 2 to 4 weeks
Treatment phase: 24 weeks
Follow-up phase: 2 weeks
All Phases: 28 to 30 weeks |
| Criteria: |
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Inclusion criteria:
- Pediatric patients with type 1 diabetes mellitus aged at least one year to less than
6 years at screening, for whom signed written informed consent has been obtained from
parent or legal guardian to participate in the study
Exclusion criteria:
- Diagnosis of type 1 diabetes for less than one year
- HbA1c at screening >12% or <6%
- Diabetes other than type 1 diabetes
- Parents and patients not willing to undergo all study assessments and treatments,
including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS)
sensor placement and maintenance both at the site and at home, multiple daily insulin
injections, and visits, as dictated by the protocol (if a telephone is not available
patients may undergo all visits in person)
- Patients and families for whom 6 days in total (not necessarily continuous) of
useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor
replacement at the site at additional screening visits if needed) during the
screening CGMS evaluations between Visit 2 and the randomization visit
- Patients treated with insulin pump therapy during the two months prior to screening
- History of primary seizure disorder
- History of severe hypoglycemic episode accompanied by seizure and/or coma, or
diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in
the 2 months prior to the screening visit
- Need for chronic treatment with acetaminophen (paracetamol)-containing medications
- Serum creatinine > 2.0mg/dL at screening
- Serum ALT or AST greater than 3x upper limit of normal for the patient's age and
gender, at screening
- Hemoglobin < 10g/dL, or platelet count less than 100,000/cu mm, at screening
- Treatment with any pharmacologic anti-hyperglycemic oral agent for more than 3 months
at any time
- Treatment with any non-insulin antihyperglycemic medication (eg, Symlin®) for the 3
months prior to screening
- Treatment with systemic glucocorticoids within the month prior to screening
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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January 20, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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