Back to resultsGlulisine + Lantus in Type I Patients
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Insuline Glulisine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
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.
Sites / Locations
- Sanofi-aventis
Outcomes
Primary Outcome Measures
Change of HbA1c.
Secondary Outcome Measures
Change in HbA1c.
Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546702
Brief Title
Glulisine + Lantus in Type I Patients
Official Title
Multicenter, Open, Non-Randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine (HMR1964) Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine During 26 Weeks of Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
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 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.
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
142 (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 in HbA1c.
Time Frame
from baseline (week 1) to weeks 12 and 26
Title
Blood glucose parameters, hypoglycaemic episodes and dosage of the mealtime and basal insulins.
Time Frame
from baseline to endpoint.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Efremenkova
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-aventis
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Glulisine + Lantus in Type I Patients
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