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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral
Pharmaceutical form: 100 mg tablets Route of administration: oral
Sanofi-Aventis Administrative Office
Guatemala City, Guatemala
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
HbA1c
Time frame: at baseline, week 12 and week 24
Fasting and postprandial glucose
Time frame: at baseline, week 2, 4, 12 and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.