20 Week Bridging Study in Type II DM

Sanofi90 enrolled

Overview

A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and safety of insulin glargine on subjects with Type 2 Diabetes Mellitus

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Type II

Interventions

Insulin GlargineDRUG

Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 Diabetes Mellitus diagnosed at least 3 years ago * Treated concomitantly with insulin once a day and SU over at least 3 months prior to study entry * Treated with OHA monotherapy over at least 1 year * HbA1c greater than or equal to 7.5% and less than or equal to 12.0%, at visit 1 (screening visit) * BMI \< 40 kg/m2 * No history of ketonemia * Women of childbearing potential using the medically approved contraceptive method * Ability and willingness to perform blood glucose monitoring using a blood glucose meter as per the requirement of protocol The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Outcomes

Primary Outcomes

To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.

Secondary Outcomes

To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.

Data from ClinicalTrials.gov

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