Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

Diabetes Mellitus, Type 2 Clinical Trial

— SUMER  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957060
• Other study ID #: GLIME_L_04140
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2009
• Last updated: November 26, 2010
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• GLIMEPIRIDE (HOE490)
Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral
• SITAGLIPTIN
Pharmaceutical form: 100 mg tablets Route of administration: oral

Locations

Country	Name	City	State
Guatemala	Sanofi-Aventis Administrative Office	Guatemala City
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Guatemala,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		at baseline, week 12 and week 24	No
Primary	Fasting and postprandial glucose		at baseline, week 2, 4, 12 and 24	No