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NCT03371108 · ClinicalTrials.gov registry record · Phase 3
Gan & Lee Insulin Glargine Target Type (2) Evaluating Research
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Gan and Lee Pharmaceuticals, U.
- Completed
- Registry status
- Phase 3
- Development phase
- 567
- Enrollment target
- 20
- Study locations
NCT03371108: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Gan and Lee Pharmaceuticals, U.
NCT03371108 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Gan and Lee Pharmaceuticals, U. The registered enrollment target is 567 participants, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03371108, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Gan and Lee Pharmaceuticals, U.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 567 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: • To evaluate 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, the percentage of subjects with at least a 4-fold increase in titers compared to baseline value, mean change from baseline in AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA who develop any anti-insulin neutralizing antibodies up to visit Week 26, and the percentage of subjects in each treatment group with confirmed positive AIA up to visit Week 26 Safety: • To evaluate the safety of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus® Efficacy: • To evaluate the efficacy of Gan \& Lee Insulin Glargine Injection in comparison with that of Lantus®
Primary Outcome
Subjects were classified as experiencing a TI-AIA or not. A TI-AIA is defined as a subject experiencing a newly confirmed positive AIA status, if they were negative at baseline or a 4-fold increase in their titer values if they were positive. The primary outcome measure is summarized as the percent of subjects experiencing a TI-AIA in the group.
Conditions Studied
Interventions
- BIOLOGICAL Gan & Lee Insulin Glargine Injection
- BIOLOGICAL Lantus®
Study Locations (20)
Florida
- Meridien Research - Bradenton
- The Center for Diabetes and Endocrine Care - Fort Lauderdale
- Homestead Associates in Research - Homestead
- Biotech Pharmaceutical Group, LLC - Miami
- Genoma Research Group - Miami
- New Horizon Research Center - Miami
- Miami Dade Medical Research Institute, LLC - Miami
- Suncoast Clinical Research, Inc. - New Port Richey
- Peninsula Research - Ormond Beach
- Oviedo Medical Research - Oviedo
California
- Valley Research - Fresno
- The Rose Salter Medical Research Foundation - Newport Coast
- California Medical Research Association - Northridge
- Northern California Research Corp. - Sacramento
Alabama
- Simon Williamson Clinic - Birmingham
- University of Alabama at Birmingham - Birmingham
- Terence T. Hart, MD - Tuscumbia
Connecticut
- CMR of Greater New Haven, LLC - Hamden
- Chase Medical Research, LLC - Waterbury
Arizona
- Family Practice Specialists - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 567 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2019-04-17 |
| Phase | Phase 3 |
What the finished NCT03371108 record still lists
NCT03371108 is an interventional study that assigns participants to a tested intervention. The registered 567 participants enrollment target is mid-sized for trials with a published cap, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Gan & Lee Insulin Glargine Injection is the first listed.
NCT03371108 names 20 study sites across 5 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03371108 about?
NCT03371108 is a clinical study titled "Gan & Lee Insulin Glargine Target Type (2) Evaluating Research". Primary Objective: • To evaluate 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...
What is the current status of trial NCT03371108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 567 participants. The study started on 2017-10-31. Estimated completion is 2019-04-17.
What conditions does trial NCT03371108 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT03371108?
The interventions under investigation include: Gan & Lee Insulin Glargine Injection (BIOLOGICAL), Lantus® (BIOLOGICAL).
Who is sponsoring clinical trial NCT03371108?
This trial is sponsored by Gan and Lee Pharmaceuticals, U, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03371108 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03371108's enrollment target sits among peer trials
567 68th of 348 higher than 281 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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