SUMERGlimepiride vs Sitagliptin for HbA1c Reduction in Type 2 Diabetes
This study aims to compare the effectiveness of Glimepiride and Sitagliptin in reducing HbA1c levels in individuals with Type 2 Diabetes, focusing on both fasting and postprandial glucose levels.
GLIMEPIRIDE (HOE490)
+ SITAGLIPTIN
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: July 1, 2009
Actual date on which the first participant was enrolled.Primary Objective: To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after 6 months of treatment in patients with monotherapy until the end of the trial. Secondary Objective: To evaluate the effect of glimepiride compared to sitagliptin in: Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c < 7% and < 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of patients with rescue therapy; Safety (adverse events and serious adverse events, hypoglycemia, vital signs and laboratory results).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.400 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion criteria: * Subject naïve to treatment * HbA1c \> 8.5 up to 11 % * Lipid lowering therapy, antihypertensive, hormonal substitutes, thyroid hormone substitutes, and contraceptives are allowed as long as they are kept at a stable dosing Exclusion criteria: * Treatment with any oral antidiabetics or insulin * Known type 1 Diabetes Mellitus * Pregnant or breast feeding women * Ketoacidosis history * History of sensitivity to any of the active substances * Renal dysfunction : serum creatinine \> or = 1.5 mg/dL in male subjects \> or = 1.4 mg/dL in female subjects * Liver impairment (ALT, AST \> 3-fold the upper limit of normal range) * Systemic corticosteroid treatment 3 months prior to study or during the study * Drug or alcohol abuse history * Patients with history of acute coronary syndrome, cerebrovascular events/transient ischaemic attack in the last three months * Presence of any condition (medical, psychological, social or geographic) current or previously seen that according to Investigators judgment jeopardizes the safety or restricts the participation of the patient during the study * Neoplasias The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Sanofi-Aventis Administrative Office
Guatemala City, GuatemalaOpen Sanofi-Aventis Administrative Office in Google MapsSanofi-Aventis Administrative Office
Col. Coyoacan, Mexico