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Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients

NCT00957060 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2010-11-30

No results posted yet for this study

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

Interventions

DRUG

GLIMEPIRIDE (HOE490)

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

DRUG

SITAGLIPTIN

Pharmaceutical form: 100 mg tablets Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Judith Diaz · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • Guatemala
  • Mexico

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00957060 on ClinicalTrials.gov