Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus (PORTAL 1)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE (HMR1964)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964574

APIDR_L_02483

Details and patient eligibility

About

Primary Objective:

To evaluate the efficacy and the safety of insulin glulisine in type I Diabetes Melittus (DM) patients

Secondary Objective:

To evaluate the insulin glulisine doses To assess the patient satisfaction

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen
• 6.5 <=HbA1c <= 11% at visit 1
• BMI <35 kg/m²
• Provision of signed and dated informed consent prior to any study procedures
• Ability and willingness to complete study diaries and questionnaires
• Demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin
• A negative pregnancy test for all females of childbearing potential.

Exclusion criteria

• Hypersensitivity to insulin Glulisine, insulin Glargine or one of their excipients
• Pregnant women
• Active proliferative diabetic retinopathy
• Impaired hepatic or renal function

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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68 participants in 1 patient group

APIDRA + LANTUS basal

Experimental group

Description:

The 2 first weeks, patients will receive subcutaneous injection of Insulin Glulisine and Insulin Glargine once daily in hospital. The rest of the treatement is to be take at home until week 12

Treatment:

Drug: INSULIN GLULISINE (HMR1964)

Drug: INSULIN GLARGINE