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

Not Applicable

• Conditions: -E119 Non-insulin-dependent diabetes mellitus, without complications; Non-insulin-dependent diabetes mellitus, without complications; E119

• Registration Number: PER-030-03
• Lead Sponsor: ADVENTRIX PHARMACEUTICALS U.S.A,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-04-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Plasma levels of RNA of VHI-1 <400 copies / mL.<br>Measure:Proportion of subjects with plasma levels of HIV-1 RNA <400 copies / mL at the end of treatment.<br>Timepoints:48 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Adverse events<br><br>Measure:Frequency of adverse events during the treatment phase and in the follow-up.<br>Timepoints:48 weeks<br>;<br>Outcome name:Plasma levels of HIV-1 RNA<br>Measure:Proportion of subjects with plasma levels of HIV-1 RNA <400 copies / mL and <50 copies / mL in Weeks 24 and 48.<br>Timepoints:week 24 and 48<br>