Gan & Lee Insulin Glargine Target Type (2) Evaluating Research
Public ClinicalTrials.gov record NCT03371108. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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®
Study identification
- NCT ID
- NCT03371108
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 567 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2017 (Actual)
- Primary completion
- Apr 17, 2019 (Actual)
- Completion
- Apr 17, 2019 (Actual)
- Last update posted
- Apr 1, 2022
2017 – 2019
United States locations
- U.S. sites
- 57
- U.S. states
- 22
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Simon Williamson Clinic | Birmingham | Alabama | 35211 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3407 | — |
| Terence T. Hart, MD | Tuscumbia | Alabama | 35674 | — |
| Family Practice Specialists | Phoenix | Arizona | 85018 | — |
| Valley Research | Fresno | California | 93720 | — |
| The Rose Salter Medical Research Foundation | Newport Coast | California | 92657 | — |
| California Medical Research Association | Northridge | California | 91324 | — |
| Northern California Research Corp. | Sacramento | California | 95821 | — |
| CMR of Greater New Haven, LLC | Hamden | Connecticut | 06517 | — |
| Chase Medical Research, LLC | Waterbury | Connecticut | 06708 | — |
| Meridien Research | Bradenton | Florida | 34201 | — |
| The Center for Diabetes and Endocrine Care | Fort Lauderdale | Florida | 33312 | — |
| Homestead Associates in Research | Homestead | Florida | 33032 | — |
| Biotech Pharmaceutical Group, LLC | Miami | Florida | 33155 | — |
| Genoma Research Group | Miami | Florida | 33165 | — |
| New Horizon Research Center | Miami | Florida | 33175 | — |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | — |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | — |
| Peninsula Research | Ormond Beach | Florida | 32174 | — |
| Oviedo Medical Research | Oviedo | Florida | 32765 | — |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | — |
| River Birch Research Alliance, LLC | Blue Ridge | Georgia | 30513 | — |
| iResearch Atlanta | Decatur | Georgia | 30030 | — |
| Sestron Clinical Research | Marietta | Georgia | 30060 | — |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | — |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | — |
| John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | — |
| Midwest CRC | Crystal Lake | Illinois | 60012 | — |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | — |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503-1473 | — |
| L-MARC Research Center | Louisville | Kentucky | 40213 | — |
| ActivMed Practices and Research - Methuen | Methuen | Massachusetts | 01844 | — |
| Palm Research Center, Inc. | Las Vegas | Nevada | 89128 | — |
| Physicians East, PA | Greenville | North Carolina | 27834 | — |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | — |
| Endocrinology Associates, Inc. | Columbus | Ohio | 43201 | — |
| Aventiv Research, Inc. | Columbus | Ohio | 43213-6523 | — |
| PriMed Clinical Research | Dayton | Ohio | 45419 | — |
| Mountain View Clinical Research | Greer | South Carolina | 29651 | — |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| ClinSearch - Clinical Research Specialists | Chattanooga | Tennessee | 37421 | — |
| New Phase Research & Development | Knoxville | Tennessee | 37909 | — |
| Austin Regional Clinic | Austin | Texas | 78726 | — |
| Texas Diabetes & Endocrinology - Central Austin | Austin | Texas | 78731-4309 | — |
| Texas Diabetes & Endocrinology - South Austin | Austin | Texas | 78749 | — |
| Sante Clinical Research | Kerrville | Texas | 78028 | — |
| Texas Diabetes & Endocrinology - Round Rock | Round Rock | Texas | 78681 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| Northeast Clinical Research of San Antonio | Schertz | Texas | 78154 | — |
| Radiant Research | Murray | Utah | 84123 | — |
| Wasatch Clinical Research, LLC | Salt Lake City | Utah | 84107 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| Burke Internal Medicine & Research | Burke | Virginia | 22105 | — |
| Stonesifer Clinical Research | Federal Way | Washington | 98003 | — |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | — |
| Clinical Investigations Specialists-Wisconsin | Kenosha | Wisconsin | 53144 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03371108, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 1, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03371108 live on ClinicalTrials.gov.