Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus

Sanofi485 enrolled

Overview

Primary: * To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus. * To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro. Secondary: * To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

485

Conditions

Diabetes Mellitus

Interventions

Insulin GlulisineDRUG

3 times a day before each meal

LisproDRUG

3 times a day before each meal

Insulin GlargineDRUG

once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetic patients * Measure HbA1c 6.5% to 11.0% at visit 1 * More than 3 months of continuous insulin treatment immediately prior to study entry Exclusion Criteria: * Pregnant women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (1)

Sanofi-Aventis

Beijing, China

Outcomes

Primary Outcomes

Hypoglycemic episodes

Time frame: From the beginning to end of the study

Change in HbA1c

Time frame: From baseline to endpoint

Adverse events

Time frame: From the beginning to the end of study

Secondary Outcomes

Change in HbA1c

Time frame: From baseline to weeks 12

blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.

Time frame: from baseline to week 12

Data from ClinicalTrials.gov

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