Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

NCT00957060 | Completed Phase 4

• 1 other identifier: GLIME_L_04140
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• HbA1c

  at baseline, week 12 and week 24

• Fasting and postprandial glucose

  at baseline, week 2, 4, 12 and 24

Study Arms (2)

glimepiride

EXPERIMENTAL

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)

sitagliptin

ACTIVE COMPARATOR

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

Drug: SITAGLIPTIN

Interventions

GLIMEPIRIDE (HOE490) DRUG

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

glimepiride

SITAGLIPTIN DRUG

Pharmaceutical form: 100 mg tablets Route of administration: oral

sitagliptin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Sanofi-Aventis Administrative Office

Guatemala City, Guatemala

Location

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepiride; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Judith Diaz

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: July 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 30, 2010

Record last verified: 2010-11

Locations

GU (1); ME (1)