Diabetes Mellitus, Type 2
Conditions
Brief summary
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).
Interventions
Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral
DRUGSITAGLIPTIN
Pharmaceutical form: 100 mg tablets Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c | at baseline, week 12 and week 24 |
| Fasting and postprandial glucose | at baseline, week 2, 4, 12 and 24 |
Countries
Guatemala, Mexico
Outcome results
None listed