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Glulisine + Lantus in Type I Patients

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 3

Locations

Ukraine

Study Type

Interventional

Intervention

Insuline glulisine

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 transplants,
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.

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

Change of HbA1c

Secondary Outcome Measures

Change of HbA1c

Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins

Full Information

NCT ID

NCT00545337

First Posted

October 15, 2007

Last Updated

October 15, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00545337

Brief Title

Glulisine + Lantus in Type I Patients

Official Title

26-week, International Multicenter, Open, Non-randomized Phase III Clinical Trial for Evaluation of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Subjects With Type 1 Diabetes Mellitus Also Using Insulin Glargine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Insuline glulisine

Primary Outcome Measure Information:

Title

Change of HbA1c

Time Frame

from baseline to endpoint

Secondary Outcome Measure Information:

Title

Change of HbA1c

Time Frame

from baseline to week 26

Title

Blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and basal insulins

Time Frame

from baseline to endpoint

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 transplants, 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Volodymyr Moshchych

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Kiev

Country

Ukraine

12. IPD Sharing Statement

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Glulisine + Lantus in Type I Patients

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