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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-FW-GLBA | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the safety of LY2409021 in healthy participants and participants with diabetes. The study drug is given as single oral doses. Each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. Side effects will be documented. This study is approximately 9 weeks long, not including screening. Screening is required within 6 weeks prior to the start of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy-Placebo | Placebo Comparator | Placebo (capsule) administered once, orally |
|
| Healthy-2.5 mg LY2409021 | Experimental | 2.5 mg LY2409021 administered once, orally |
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| Healthy-10 mg LY2409021 | Experimental | 10 mg LY2409021 administered once, orally |
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| Healthy-30 mg LY2409021 | Experimental | 30 mg LY2409021 administered once, orally |
|
| Healthy-100 mg LY2409021 | Experimental | 100 mg LY2409021 administered once, orally |
|
| Healthy-250 mg LY2409021 | Experimental | 250 mg LY2409021 administered once, orally |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally |
| |
| 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 14 days after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021 | From each dose of study drug up to 14 days post dose | |
| Pharmacokinetics: Maximum concentration (Cmax) of LY2409021 | From each dose of study drug up to 14 days post dose |
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Inclusion Criteria:
For all participants:
For healthy participants:
For participants with type 2 diabetes mellitus (T2DM):
Exclusion Criteria:
For all participants:
For participants with T2DM:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 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 |
|---|---|---|---|
| 25656305 | Derived | 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. |
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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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| Healthy-500 mg LY2409021 | Experimental | 500 mg LY2409021 administered once, orally |
|
| Diabetic-Placebo | Placebo Comparator | Placebo (capsule) administered once, orally |
|
| Diabetic-75 mg LY2409021 | Experimental | 75 mg LY2409021 administered once, orally |
|
| Diabetic-200 mg LY2409021 | Experimental | 200 mg LY2409021 administered once, orally |
|
| Diabetic-500 mg LY2409021 | Experimental | 500 mg LY2409021 administered once, orally |
|
| LY2409021 |
| Drug |
Administered orally |
|
| Change in fasting blood glucose level | From each dose of study drug up to 48 hours post dose |
| Change in fasting insulin level | From each dose of study drug up to 48 hours post dose |
| Change in fasting glucagon level | From each dose of study drug up to 48 hours post dose |
| Change in fasting glucagon-like peptide-1 (GLP-1) level | From each dose of study drug up to 24 hours post dose |
| Glucose excursion after meals | 28 hours after each dose |
| Singapore |
| D004700 | Endocrine System Diseases |