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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Lispro; Drug: Insulin Glulisine; Drug: Insulin Glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00467376

APIDR_L_00348

Details and patient eligibility

About

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

Enrollment: 485 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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485 participants in 2 patient groups

1

Experimental group

Description:

Administration of Insulin Glulisine

Treatment:

Drug: Insulin Glulisine

Drug: Insulin Glargine

2

Active Comparator group

Description:

Administration of Lispro

Treatment:

Drug: Insulin Glargine

Drug: Lispro