ClinicalTrials.gov record
Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro
ClinicalTrials.gov ID: NCT04254380
Public ClinicalTrials.gov record NCT04254380. 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.
ClinicalTrials.gov public records Last synced Apr 29, 2026, 9:07 AM EDT
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 Insulin Lispro Injection to Humalog in Adult Subjects With Type 1 Diabetes Mellitus (T1DM)
Study identification
- NCT ID
- NCT04254380
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Gan and Lee Pharmaceuticals, USA
- Industry
- Enrollment
- Not listed
Conditions and interventions
Conditions
Not listed
Interventions
Not listed
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
- Dec 3, 2019
- Primary completion
- Jan 26, 2020
- Completion
- Jan 26, 2020
- Last update posted
- Feb 4, 2020
2019 – 2020
United States locations
- U.S. sites
- 56
- U.S. states
- 19
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Research Center | Anaheim | California | 92805 | — |
| Valley Research | Fresno | California | 93720 | — |
| Angel City Research, Inc. | Los Angeles | California | 90057 | — |
| California Medical Research Association | Northridge | California | 91324 | — |
| Mills-Peninsula Health Services | San Mateo | California | 94401 | — |
| Care Access Research - Santa Clarita | Santa Clarita | California | 91321 | — |
| Metabolic Institute of America | Tarzana | California | 91356 | — |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | — |
| IMMUNOe International Research Centers - Longmont | Longmont | Colorado | 80501 | — |
| Chase Medical Research of Greater New Haven | Hamden | Connecticut | 06517 | — |
| The Center for Diabetes and Endocrine Care | Fort Lauderdale | Florida | 33312 | — |
| M & O Clinical Research | Fort Lauderdale | Florida | 33316 | — |
| Sweet Hope Research Specialty Inc. | Hialeah | Florida | 33016 | — |
| Homestead Associates in Research | Homestead | Florida | 33032 | — |
| Med Research of Florida | Miami | Florida | 33186 | — |
| Suncoast Clinical Research - Pasco County | New Port Richey | Florida | 34652 | — |
| Florida Institute for Clinical Research, LLC | Orlando | Florida | 32825 | — |
| Ormond Beach Clinical Research | Ormond Beach | Florida | 32174 | — |
| Suncoast Clinical Research - Pinellas County | Palm Harbor | Florida | 34684 | — |
| Meridien Research - Spring Hill | Spring Hill | Florida | 34609 | — |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| IACT Health - Columbus Regional Medical Group Endocrine Consultants - Columbus | Columbus | Georgia | 31904 | — |
| IACT Health - Columbus Regional Medical Group Endocrine Consultants | Newnan | Georgia | 30265 | — |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | — |
| Cedar Crosse Research Center | Chicago | Illinois | 60607 | — |
| Midwest CRC | Crystal Lake | Illinois | 60012 | — |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | — |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503 | — |
| Bay West Endocrinology Associates | Baltimore | Maryland | 21204 | — |
| BTC Network - Capital Diabetes and Endocrine Associates - Camp Springs | Camp Springs | Maryland | 20746 | — |
| Endocrine & Metabolic Consultants | Rockville | Maryland | 20852 | — |
| Quality Clinical Research | Omaha | Nebraska | 68134 | — |
| Palm Research Center | Las Vegas | Nevada | 89148 | — |
| BTC Network - Garden State Endocrinology - Brick | Brick | New Jersey | 08723 | — |
| The Endocrine Group, LLP | Albany | New York | 12206 | — |
| North Shore Diabetes and Endocrine Associates | New Hyde Park | New York | 11042 | — |
| University Physicians Group | Staten Island | New York | 10301 | — |
| PharmQuest | Greensboro | North Carolina | 27408 | — |
| Physicians East - Greenville | Greenville | North Carolina | 27834 | — |
| Carteret Medical Group - Morehead City | Morehead City | North Carolina | 28557 | — |
| Endocrinology Research Associates | Columbus | Ohio | 43201 | — |
| Your Diabetes Endocrine Nutrition Group, Inc. | Mentor | Ohio | 44060 | — |
| Intend Research | Norman | Oklahoma | 73069 | — |
| Lynn Institute of Stillwater | Stillwater | Oklahoma | 73111 | — |
| Care Access Research - Warwick | Warwick | Rhode Island | 02886 | — |
| University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| Amarillo Medical Specialists | Amarillo | Texas | 79106 | — |
| Austin Regional Clinic | Austin | Texas | 78704 | — |
| Texas Diabetes & Endocrinology - Central Austin | Austin | Texas | 78731 | — |
| Research Institute of Dallas | Dallas | Texas | 75231 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| El Paso Medical Research Institute | El Paso | Texas | 79935 | — |
| Pioneer Research Solutions | Houston | Texas | 77099 | — |
| Austin Regional Clinic - Kelly Lane | Pflugerville | Texas | 78660 | — |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | — |
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 NCT04254380, 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 Feb 4, 2020 · Synced Apr 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04254380 live on ClinicalTrials.gov.