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| ID | Type | Description | Link |
|---|---|---|---|
| J4P-MC-IYAC | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 diabetes. Participation in the study will last about 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3938577 | Experimental | Participants will receive LY3938577 subcutaneously (SC) |
|
| Degludec | Active Comparator | Participants will receive degludec SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3938577 | Drug | Administered SC |
| |
| Degludec |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis) | Baseline through Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Superiority Analysis) | Baseline through Week 20 | |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Clinical Research Institute | Active, not recruiting | Tucson | Arizona | 85712 | United States | |
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| Label | URL |
|---|---|
| A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Drug |
Administered SC |
|
| Pharmacokinetics (PK): Average Concentration of LY3938577 | Baseline through Week 20 |
| Encompass Clinical Research |
| Active, not recruiting |
| Spring Valley |
| California |
| 91978 |
| United States |
| University Clinical Investigators, Inc. | Completed | Tustin | California | 92780 | United States |
| Tampa Bay Medical Research | Active, not recruiting | Clearwater | Florida | 33761 | United States |
| Encore Medical Research | Active, not recruiting | Hollywood | Florida | 33024 | United States |
| Clinical Research of Central Florida | Completed | Lakeland | Florida | 33805 | United States |
| Encore Medical Research - Weston | Active, not recruiting | Weston | Florida | 33331 | United States |
| Iowa Diabetes and Endocrinology Research Center | Active, not recruiting | West Des Moines | Iowa | 50266 | United States |
| Washington University School of Medicine | Completed | St Louis | Missouri | 63110 | United States |
| Accellacare - Wilmington | Recruiting | Wilmington | North Carolina | 28401 | United States |
|
| AMR Clinical | Completed | Norman | Oklahoma | 73069 | United States |
| Tribe Clinical Research, LLC | Completed | Greenville | South Carolina | 29607 | United States |
| Holston Medical Group | Recruiting | Bristol | Tennessee | 37620 | United States |
|
| Texas Diabetes & Endocrinology, P.A. | Active, not recruiting | Austin | Texas | 78749 | United States |
| Velocity Clinical Research, Dallas | Active, not recruiting | Dallas | Texas | 75230 | United States |
| Juno Research | Active, not recruiting | Houston | Texas | 77040 | United States |
| Southern Endocrinology Associates | Completed | Mesquite | Texas | 75149 | United States |
| Consano Clinical Research, LLC | Completed | Shavano Park | Texas | 78231 | United States |
| Texas Valley Clinical Research | Active, not recruiting | Weslaco | Texas | 78596 | United States |
| Chrysalis Clinical Research | Recruiting | St. George | Utah | 84790 | United States |
|
| Cicemo Srl | Recruiting | Buenos Aires | 1424 | Argentina |
|
| CIPREC | Recruiting | Buenos Aires | C1119ACN | Argentina |
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| Mautalen Salud e Investigación | Recruiting | Buenos Aires | C1128AAF | Argentina |
|
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Recruiting | Buenos Aires | C1425AGC | Argentina |
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| Instituto Centenario | Recruiting | CABA | 1204 | Argentina |
|
| Instituto Médico Catamarca IMEC | Recruiting | Rosario | 2000 | Argentina |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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