Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Glimepiride; Sitagliptin Phosphate

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.