Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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®
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03371108
The ClinicalTrials.gov registry entry for NCT03371108 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 567 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,484-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (87% lower). The listed sponsor is Gan and Lee Pharmaceuticals, U, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
-
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
RECRUITING · Phase 3
-
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
ACTIVE NOT RECRUITING · Phase 3
-
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
ACTIVE NOT RECRUITING · Phase 3
-
A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.