Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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).

Official Title
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A Multicenter, Open, Randomized, 24 Weeks Study to Evaluate the Superiority of Glimepiride Over Sitagliptin for the Treatment of naïve Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GLIMEPIRIDE (HOE490)
* Drug: SITAGLIPTIN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glimepiride<br>The initial dose is 2 mg once a day. At week 2, the dose can be increased to 4 mg once a day according to the titration. At week 4 and 12, the dose can be increased from 2 mg to 4 mg or from 4 mg to 6 mg according to the titration. | Drug: GLIMEPIRIDE (HOE490)<br>* Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral<br>|
| Active Comparator: sitagliptin<br>100 mg once a day. The dose will not be titrated. | Drug: SITAGLIPTIN<br>* Pharmaceutical form: 100 mg tablets Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | at baseline, week 12 and week 24 | 
| Fasting and postprandial glucose |  | at baseline, week 2, 4, 12 and 24 |