None listed
Conditions
Interventions
Glimepiride Type of group
Glimepiride will be administered as monotherapy for 24 weeks. Patients will be stratified by age: they are 12 years old or younger, over 12 years old, and patients who undergo
Tanner classification.
Group name:Metformin Type of group
Metformin will be administered as monotherapy for 24 weeks. Patients will be stratified by age: they are 12 years old or younger, over 12 years old, and patients who undergo
Tanner classification.
Sponsors
ADVENTRIX PHARMACEUTICALS U.S.A,
Eligibility
Inclusion criteria
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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Plasma levels of RNA of VHI-1 <400 copies / mL. Measure:Proportion of subjects with plasma levels of HIV-1 RNA <400 copies / mL at the end of treatment. Timepoints:48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse events Measure:Frequency of adverse events during the treatment phase and in the follow-up. Timepoints:48 weeks ; Outcome name:Plasma levels of HIV-1 RNA Measure:Proportion of subjects with plasma levels of HIV-1 RNA <400 copies / mL and <50 copies / mL in Weeks 24 and 48. Timepoints:week 24 and 48 | — |
Countries
Germany, Mexico
Outcome results
None listed