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
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
34509 9th Avenue South
Federal Way, Washington 98003
Federal Way, Washington 98003
Phone: 253.815.6880
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
18531 Roscoe Boulevard
Northridge, California 91324
Northridge, California 91324
Phone: 818-349-1979
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials