- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00467376
Insulin Glulisine, Insulin Lispro and Insulin Glargine in Type 1 or 2 Diabetes Mellitus
September 14, 2009 updated by: Sanofi
12-week, Multicenter, Controlled, Open, 3:1 Randomized, Parallel Clinical Trial Comparing Insulin Glulisine With Regular Human Insulin (Insulin Lispro) Injected Subcutaneously in Subjects With Type 1 or 2 Diabetes Mellitus Also Using Lantus (Insulin Glargine)
Primary:
- To compare the efficacy and safety of Insulin Glulisine to Insulin Lispro in subjects with type 1 or type 2 diabetes mellitus.
- To compare the frequency of hypoglycemia of Insulin Glulisine to Insulin Lispro.
Secondary:
- To compare Insulin Glulisine to Insulin Lispro in terms of the change in HbA1c at weeks 12, blood glucose parameters, insulin doses and treatment satisfaction in subjects with type 1 or type 2 diabetes mellitus
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
485
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Sanofi-Aventis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 1 or type 2 diabetic patients
- Measure HbA1c 6.5% to 11.0% at visit 1
- More than 3 months of continuous insulin treatment immediately prior to study entry
Exclusion Criteria:
- Pregnant women
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Administration of Insulin Glulisine
|
3 times a day before each meal
once daily
|
Active Comparator: 2
Administration of Lispro
|
once daily
3 times a day before each meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hypoglycemic episodes
Time Frame: From the beginning to end of the study
|
From the beginning to end of the study
|
Change in HbA1c
Time Frame: From baseline to endpoint
|
From baseline to endpoint
|
Adverse events
Time Frame: From the beginning to the end of study
|
From the beginning to the end of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c
Time Frame: From baseline to weeks 12
|
From baseline to weeks 12
|
blood glucose parameters, hypoglycemic episodes and dosage of the mealtime and Lantus.
Time Frame: from baseline to week 12
|
from baseline to week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jing Fu, Sanofi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
April 27, 2007
First Submitted That Met QC Criteria
April 27, 2007
First Posted (Estimate)
April 30, 2007
Study Record Updates
Last Update Posted (Estimate)
September 15, 2009
Last Update Submitted That Met QC Criteria
September 14, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APIDR_L_00348
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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