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Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients

NCT01459809 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2015-01-21

No results posted yet for this study

Summary

Primary Objective:

\- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus.

Secondary Objectives:

\- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on:

* Percentage of patients reaching HbA1c \< 7%
* Percentage of patients reaching HbA1c \< 6.5%
* Fasting Plasma Glucose (FPG)
* Safety and tolerability

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

GLIMEPIRIDE

Pharmaceutical form: oral Route of administration: oral

DRUG

METFORMIN

Pharmaceutical form: oral Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Algeria
  • Colombia
  • Egypt
  • Guatemala
  • India
  • Iran
  • Lebanon
  • Mexico
  • Russia
  • South Africa
  • Tunisia
  • Turkey (Türkiye)
  • Ukraine
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Drugs
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 NCT01459809 on ClinicalTrials.gov