Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective: • To compare the immunogenicity of Gan \& Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM Secondary Objectives: * To evaluate the safety of Gan \& Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM * To evaluate the efficacy of Gan \& Lee Insulin Lispro Injection in comparison with that of EU authorized Humalog following treatment in adult subjects with T1DM
Study identification
- NCT ID
- NCT04254380
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
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
- Dec 4, 2019 (Actual)
- Primary completion
- Jan 27, 2020 (Actual)
- Completion
- Jan 27, 2020 (Actual)
- Last update posted
- Feb 5, 2020
2019 – 2020
United States locations
- U.S. sites
- 58
- U.S. states
- 19
- U.S. cities
- 55
| 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 | — |
| Northeast Clinical Research of San Antonio | Schertz | Texas | 78154 | — |
| Crossroads Clinical Research | Victoria | Texas | 77901 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 49 non-U.S. sites.
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 5, 2020 · Synced Oct 21, 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 public registry record, listed eligibility criteria, and available contact information for NCT04254380 live on ClinicalTrials.gov.