Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

NCT ID: NCT00957060

Last Updated: 2010-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-10-31

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).

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

glimepiride

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.

Group Type: EXPERIMENTAL

GLIMEPIRIDE (HOE490)

Intervention Type: DRUG

Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral

sitagliptin

100 mg once a day. The dose will not be titrated.

Group Type: ACTIVE_COMPARATOR

SITAGLIPTIN

Intervention Type: DRUG

Pharmaceutical form: 100 mg tablets Route of administration: oral

Interventions

GLIMEPIRIDE (HOE490)

Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral

Intervention Type: DRUG

SITAGLIPTIN

Pharmaceutical form: 100 mg tablets Route of administration: oral

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Judith Diaz

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Guatemala City, , Guatemala

Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Countries

Guatemala; Mexico

Other Identifiers

GLIME_L_04140

Identifier Type: -

Identifier Source: org_study_id