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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-FW-GLBB | Other Identifier | Eli Lilly and Company |
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The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo administered orally once daily for 4 weeks |
|
| 5 mg LY2409021 | Experimental | 5 mg LY2409021 administered orally once daily for 4 weeks |
|
| 30 mg LY2409021 | Experimental | 30 mg LY2409021 administered orally once daily for 4 weeks |
|
| 60 mg LY2409021 | Experimental | 60 mg LY2409021 administered orally once daily for 4 weeks |
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| 90 mg LY2409021 | Experimental | 90 mg LY2409021 administered orally once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally (capsule) |
| |
| LY2409021 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more drug related adverse events (AEs) or any serious AEs | From first dose of study drug up to discharge (at least 28 days after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021 | From first study drug dose to Day 28 post last dose | |
| Pharmacokinetics: Maximum concentration (Cmax) of LY2409021 | From first study drug dose to Day 28 post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40526184 | Derived | Tan AYF, Schneck K, Garhyan P, Chan ECY, Tham LS. Evaluation of Four Semi-Mechanistic Models for Predicting Glycemic Control With a Glucagon Receptor Antagonist in People With Type 2 Diabetes. CPT Pharmacometrics Syst Pharmacol. 2025 Aug;14(8):1381-1390. doi: 10.1002/psp4.70058. Epub 2025 Jun 17. | |
| 25656305 | Derived |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000601762 | adomeglivant |
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| Drug |
Administered orally (capsule) |
|
| Change in fasting blood glucose level | From Day -1 to Day 28 of dosing |
| Change in incremental area under the curve (AUC) for glucose | From Day -1 to Day 28 of dosing |
| Change in homeostasis model assessment of beta cell function (HOMA-B) | From baseline to Day 28 |
| Change in fasting glucagon level | From Day -1 to Day 28 of dosing |
| Change in fasting insulin level | From Day -1 to Day 28 of dosing |
| Change in fasting C-peptide level | From Day -1 to Day 28 of dosing |
| Change in fasting glucagon-like peptide-1 (GLP-1) level | From Day -1 to Day 28 of dosing |
| Singapore |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Plymouth | United Kingdom |
| Kelly RP, Garhyan P, Raddad E, Fu H, Lim CN, Prince MJ, Pinaire JA, Loh MT, Deeg MA. Short-term administration of the glucagon receptor antagonist LY2409021 lowers blood glucose in healthy people and in those with type 2 diabetes. Diabetes Obes Metab. 2015 Apr;17(4):414-22. doi: 10.1111/dom.12446. Epub 2015 Mar 2. |
| D004700 | Endocrine System Diseases |