Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 7/12/2018 |
| Start Date: | October 20, 2017 |
| End Date: | January 31, 2020 |
| Contact: | Gan & Lee Pharmaceuticals, USA |
| Email: | ClinicalTrials@GanLee.US |
| Phone: | 844.218.5504 |
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 1 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 1 Diabetes
We found this trial at
51
sites
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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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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: 253.815.6880
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18531 Roscoe Boulevard
Northridge, California 91324
Northridge, California 91324
Phone: 818-349-1979
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