Insulin Glulisine, Diabetes Mellitus Type 1

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00397553

HMR1964A_3517

Details and patient eligibility

About

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes mellitus, Type 1
• HbA1c 6.5-11.0%
• BMI <35 kg/m²

Exclusion criteria

• Diabetes mellitus, Type 2

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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Insulin Glulisine

Experimental group

Treatment:

Drug: Insulin glulisine