Insulin Glargine, INITIATE Metabolic and Economic Outcomes of Lantus

Sanofi124 enrolled

Overview

To introduce initiation of glargine insulin treatment in primary care based on a patient education program. To show and compare feasibility of group education to individual education program.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Diabetes Mellitus

Interventions

Insulin GlargineDRUG

Insulin glargine administered by subcutaneous injection daily at bedtime for 24 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Insulin-naive Type 2 Diabetes Mellitus subjects, aged ≥18 years and on stable oral anti-diabetic treatment for \>6 months requiring basal long-acting insulin (HbA1c \>7.5 % and \<12.0 %). Exclusion Criteria: * The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (4)

Sanofi-Aventis

Helsinki, Finland

Sanofi-Aventis

Amsterdam, Netherlands

Sanofi-Aventis

Stockholm, Sweden

Sanofi-Aventis

Leicester, United Kingdom

Outcomes

Primary Outcomes

Superiority is based on observing clinically significant difference in glycaemic control (> than or = to 0,5 % HbA1c). Programs are defined as equally successful if the HbA1c differs less than 0,5 %.

Time frame: HbA1c values at visits 1, 2, 5 and 10

Data from ClinicalTrials.gov

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