Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride

Sanofi43 enrolled

Overview

Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

GLIMEPIRIDEDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women aged 35 to 70 years * Having given their consent * Type 2 diabetics (HBA1c greater than 6.5% * Fasting glycaemia greater than 1.40 g/l) not controlled by Metformin for at least 6 weeks.

Locations (1)

Sanofi-Aventis

Paris, France

Outcomes

Primary Outcomes

Change in interstitial glucose levels between the observation and maintenance phases.

Time frame: The mean of 24 variations in average hourly glucose readings recorded by CGMS.

Secondary Outcomes

HbA1c and fasting blood glucose levels.

Time frame: Measured in the observation and maintenance phases, and change between the two phases.

Data from ClinicalTrials.gov

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