Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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 glimepiride or metformin as monotherapy.

Key facts

Study ID: NCT00353691
Run by: Sanofi
People needed: 100
Starts: 2002-10-01
Expected to finish: 2004-11-01
Last updated by the study team: 2011-01-11

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Sanofi-Aventis — Bridgewater, New Jersey, United States

Full record on ClinicalTrials.gov

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