Glulisine + Lantus in Type I Patients

NCT ID: NCT00546702

Last Updated: 2009-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2005-02-28

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insuline Glulisine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Olga Efremenkova

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-aventis

Moscow, , Russia

Countries

Russia

Other Identifiers

HMR1964A_3505

Identifier Type: -

Identifier Source: org_study_id