An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus
Public ClinicalTrials.gov record NCT02561078. 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
Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.
Study identification
- NCT ID
- NCT02561078
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 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 20, 2015 (Actual)
- Primary completion
- May 9, 2017 (Actual)
- Completion
- May 9, 2017 (Actual)
- Last update posted
- May 20, 2020
2015 – 2017
United States locations
- U.S. sites
- 52
- U.S. states
- 26
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Internal Medicine Center LLC | Mobile | Alabama | 36608 | — |
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | — |
| Valley Endocrine, Fresno | Fresno | California | 93720 | — |
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 | — |
| Diabetes and Endocrine Associates | La Mesa | California | 91942 | — |
| First Valley Medical Group | Lancaster | California | 93534 | — |
| Pacific Research Partners, LLC | Oakland | California | 94607 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| NorCal Endocrinology and Internal Medicine - Roseville | Roseville | California | 95661 | — |
| NorCal Endocrinology and Internal Medicine - Roseville | San Ramon | California | 94583 | — |
| Olive View Medical Center | Sylmar | California | 91342 | — |
| ALL Medical Research, LLC | Cooper City | Florida | 33024 | — |
| East Coast Institute For Research, LLC | Jacksonville | Florida | 32216 | — |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | — |
| Metabolic Research Institute Inc. | West Palm Beach | Florida | 33401 | — |
| East Coast Institute For Research, LLC | Macon | Georgia | 31210 | — |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | — |
| John H. Stroger Hospital of Cook County | Chicago | Illinois | 60612 | — |
| Midwest CRC | Crystal Lake | Illinois | 60012 | — |
| HSHS Medical Group Diabetes Research | Springfield | Illinois | 62711 | — |
| Iderc, P.L.C. | Des Moines | Iowa | 50314 | — |
| Cotton O'Neil Diabetes and Endocrinology Center | Topeka | Kansas | 66606 | — |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503 | — |
| The Arthritis & Diabetes Clinic Inc. | Monroe | Louisiana | 71203 | — |
| Grunberger Diabetes Institute | Bloomfield Hills | Michigan | 48302 | — |
| Adult Endocrinology Consultants, P.C. | Livonia | Michigan | 48154 | — |
| JCMG Clinical Research | Jefferson City | Missouri | 65109 | — |
| Billings Clinic Research Center | Billings | Montana | 59101 | — |
| Diabetes and Endocrinology Associates | Omaha | Nebraska | 68114 | — |
| Palm Research Center | Las Vegas | Nevada | 89128 | — |
| Palm Research Center | Las Vegas | Nevada | 89148 | — |
| Southern New Hampshire Diabetes and Endocrinology | Nashua | New Hampshire | 03063 | — |
| North Shore Diabetes and Endocrine Assoc | New Hyde Park | New York | 11040 | — |
| Mountain Diabetes and Endocrine Center | Asheville | North Carolina | 28803 | — |
| Physicians East | Greenville | North Carolina | 27834 | — |
| PMG Research of Rocky Mount, LLC | Rocky Mount | North Carolina | 27804 | — |
| University of Oklahoma Health Sciences Center-Tulsa | Oklahoma City | Oklahoma | 73104 | — |
| Portland Diabetes & Endocrine Center | Portland | Oregon | 97210 | — |
| Endocrine Metabolic Associates, P.C. | Philadelphia | Pennsylvania | 19114 | — |
| Partners in Nephrology & Endocrinology | Pittsburgh | Pennsylvania | 15224 | — |
| Sudhir Bansal M.D. Inc. | Warwick | Rhode Island | 02886 | — |
| AM Diabetes and Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| University Diabetes and Endocrine Consultants | Chattanooga | Tennessee | 37411 | — |
| Vanderbilt Univeristy School of Medicine | Nashville | Tennessee | 37232 | — |
| Texas Diabetes and Endocrinology-Austin South | Austin | Texas | 78749 | — |
| Dallas Diabetes Endocrine Center | Dallas | Texas | 75230 | — |
| Texas Diabetes and Endocrinology, P.A. | Round Rock | Texas | 78681 | — |
| Advanced Research Institute | South Ogden | Utah | 84405 | — |
| Dr. Larry Stonesifer | Federal Way | Washington | 98003 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
| Northside Internal Medicine | Spokane | Washington | 99208 | — |
| Multicare Health System | Tacoma | Washington | 98405 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02561078, 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 May 20, 2020 · Synced Oct 16, 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 NCT02561078 live on ClinicalTrials.gov.