Status:
COMPLETED
Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
8-17 years
Phase:
PHASE3
Brief Summary
To compare the change in glycemic control from baseline to endpoint (last available posttreatment assessment) as measured by HbA1c in pediatric subjects with type 2 diabetes receiving either glimepiri...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects who had type 2 diabetes treated with diet and exercise only for at least 2 weeks prior to randomization, or who were previously or currently treated with an oral agent and had not responded to diet, exercise, and oral therapy for at least 3 months (documented by an HbA1c \>7.5%).
- Subjects who completed glimepiride pharmacokinetic Study HOE 490/4045 at preselected sites within 3 weeks prior to the screening period were also permitted to enroll.
- Subjects were required to be negative for islet cell antigen (ICA) and glutamic acid decarboxylase (GAD) autoantibodies and to have a C-peptide level at 90 minutes of ≥ 1.5 ng/mL. The HbA1c was required to be \>7.1% at screening and \<12.0% on the day of randomization.
- EXCLUSION CRITERIA:
- Subjects meeting any of the following criteria were not to be included in the study:
- A history of an acute metabolic complication such as diabetic ketoacidosis within 3 months before screening
- On insulin therapy, or had received insulin for \>6 weeks, 3 months prior to randomization
- On weight-reduction medication
- Known hypersensitivity to biguanides, sulfonamides, or insulin
- Pregnant or lactating females
- Clinically significant renal (serum creatinine level \>1.0 mg/dL) or hepatic disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>2.5 times the upper limits of normal \[ULN\])
- GI disorders that may interfere with the absorption of the study drugs
- Chronic use of medications known to affect glucose levels such as intermittent use of systemic corticosteroids or large dose of inhaled steroids
- Clinically significant laboratory abnormality on screening laboratory tests or any medical condition that in the opinion of the investigator would affect the outcome of the study
- History of drug or alcohol abuse
- Treatment with any investigational product in the last 3 months before study entry
- History of noncompliance with regard to follow-up medical care
- Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00353691
Start Date
October 1 2002
End Date
November 1 2004
Last Update
January 11 2011
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807