Glulisine + Lantus in Type I Patients

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insuline Glulisine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546702

HMR1964A_3505

Details and patient eligibility

About

To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus To evaluate the change in HbA1c at week 26, blood/glucose parameters, hypoglycemia, insulin dose in subjects with type I diabetes mellitus receiving HMR 1964 and insulin glargine.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men and women (>18 years) with type I diabetes mellitus (onset of diabetes under the age of 40)
• An HbA1c range of >6.5 - <11%
• And on multiple injection regimen (more than 1 year of continuous insulin treatment)
• Body mass index <35.

Exclusion criteria

• Active proliferative diabetic retinopathy
• Diabetes other than type I diabetes mellitus
• Pancreatectomised subjects
• Subjects who have undergone pancreas and or islet cell transplantats, requiring treatment with not permited drugs during the study, previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine
• Hypersensitivity to insulin
• Major systemic diseases
• 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)