Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: GLIMEPIRIDE (HOE490) (Drug); SITAGLIPTIN (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Judith Diaz, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com

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: 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

HbA1c

Fasting and postprandial glucose

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com

Sanofi-aventis Administrative Office, Mexico, Mexico; Recruiting

Starting date: July 2009
Ending date: July 2010
Last updated: August 11, 2009