Back to resultsInsulin Glulisine, Diabetes Mellitus Type 1
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Insulin glulisine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
Eligibility Criteria
Inclusion Criteria:
- Diabetes mellitus, Type 1
- HbA1c 6.5-11.0%
- BMI <35 kg/m²
Exclusion Criteria:
- Diabetes mellitus, Type 2
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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Insulin Glulisine
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
Secondary Outcome Measures
HbA1c
Fasting Blood Glucose
Fasting Blood Glucose
Post-prandial glycemia (2 hour after breakfast)
Post-prandial glycemia (2 hour after breakfast)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00397553
Brief Title
Insulin Glulisine, Diabetes Mellitus Type 1
Official Title
Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy
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
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin Glulisine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Insulin glulisine
Primary Outcome Measure Information:
Title
HbA1c
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
26 weeks
Title
Fasting Blood Glucose
Time Frame
26 weeks
Title
Fasting Blood Glucose
Time Frame
52 weeks
Title
Post-prandial glycemia (2 hour after breakfast)
Time Frame
26 weeks
Title
Post-prandial glycemia (2 hour after breakfast)
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetes mellitus, Type 1
HbA1c 6.5-11.0%
BMI <35 kg/m²
Exclusion Criteria:
Diabetes mellitus, Type 2
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
Marina Atarshchikova, MD
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
Insulin Glulisine, Diabetes Mellitus Type 1
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