Glulisine + Lantus in Type I Patients

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00546702
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-12
• Last Update Posted: 2009-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of HbA1c.	from baseline to endpoint.

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c.	from baseline (week 1) to weeks 12 and 26
Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.	from baseline to endpoint.

Trial Locations

Locations (1)

Sanofi-aventis; 🇷🇺 Moscow, Russian Federation