Gan & Lee Insulin Glargine Target Type (2) Evaluating Research
Status: | Recruiting |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 5/20/2018 |
Start Date: | October 20, 2017 |
End Date: | January 31, 2020 |
Contact: | Gan & Lee Pharmaceuticals, USA |
Email: | ClinicalTrials@GanLee.US |
Phone: | 8442185504 |
AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE III STUDY TO COMPARE THE IMMUNOGENICITY, EFFICACY, AND SAFETY OF GAN & LEE PHARMACEUTICALS INSULIN GLARGINE INJECTION TO LANTUS® IN ADULT SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Primary Objective:
• To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of
immunogenicity
Secondary Objective:
• Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin
antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26
• To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of
immunogenicity
Secondary Objective:
• Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin
antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26
Inclusion Criteria:
- Type 2 Diabetes
We found this trial at
57
sites
1031 Office Park Road
West Des Moines, Iowa 50265
West Des Moines, Iowa 50265
Phone: 515-329-6800
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1720 2nd Ave S
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 934-4011
Phone: 205-934-4112
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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500 Chase Parkway
Waterbury, Connecticut 06708
Waterbury, Connecticut 06708
203-419-4420
Phone: 203-419-4404
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1969 W Ogden Ave
Chicago, Illinois 60612
Chicago, Illinois 60612
(312) 864-6000
Phone: 312-864-0537
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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34509 9th Avenue South
Federal Way, Washington 98003
Federal Way, Washington 98003
Phone: 253.927.7256
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5017 Green Bay Road
Kenosha, Wisconsin 53144
Kenosha, Wisconsin 53144
Phone: 262-925-1282
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18531 Roscoe Boulevard
Northridge, California 91324
Northridge, California 91324
Phone: 818-349-1979
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