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

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