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Efficacy and Safety Compariso...

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

Last Updated: 2015-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

538 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-01-31

Brief Summary

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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

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Detailed Description

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The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARM 1: glimepiride alone

24-week treatment period: After randomization, starting dose will be of 2 mg /day or 1 mg/day of glimepiride if Fasting Plasma Glucose (FPG) at baseline \< 180 mg/dL (10 mmol/L) taken once in the morning before breakfast. The treatment's dose will be increased every 2 weeks up to the maximum tolerated dose of 4 mg, and adjusted throughout the 24-week treatment period according to fasting Self Monitored Plasma Glucose (SMPG) values in the objective to obtain fasting SMPG values ≤ 130mg/dL (7.2mmol/L) and \> 70 mg/dL (3.9mmol/L) without symptomatic hypoglycemia.

Group Type EXPERIMENTAL