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| ID | Type | Description | Link |
|---|---|---|---|
| I1R-MC-GLBR | Other Identifier | Eli Lilly and Company | |
| 2011-006178-19 | EudraCT Number |
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This study involves taking a single dose of 100 milligrams (mg) or 300 mg LY2409021 or placebo (an inactive medicine) taken as up to 3 capsules by mouth. The study will evaluate if this drug will reduce the amount of insulin a type 1 diabetic needs over 24 hours. This study includes a 7-day hospitalization period at the clinical research unit (CRU) and will involve screening within 30 days of the start of the study as well as telephone consultations within 5 days after discharge from the CRU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg LY2409021 | Experimental | LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
|
| 300 mg LY2409021 | Experimental | LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
|
| Placebo | Placebo Comparator | Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2409021 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose | The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported. | Baseline (Day 1), Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin | The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported. | Baseline (Day 1), Day 2 |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 |
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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. | Neuss | 41460 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg LY2409021 | LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| FG001 | 300 mg LY2409021 | LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| FG002 | Placebo | Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg LY2409021 | LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| BG001 | 300 mg LY2409021 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose | The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported. | All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data. | Posted | Mean | Standard Deviation | insulin units | Baseline (Day 1), Day 2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 100 mg LY2409021 | LY2409021: 100 milligrams (mg), 1 capsule, administered as a single oral dose on Day 2. Placebo: 2 capsules, administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| 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 |
| D005934 | Glucagon |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo |
| Drug |
Administered orally |
|
| Glucagon | Drug | Administered via intramuscular injection |
|
| Predose (Day 2) through 120 hours postdose (Day 7) |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 | Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported. | Predose (Day 2) through 120 hours postdose (Day 7) |
| Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period | Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis. | Baseline (Day 1), Day 3 up to Day 6 |
| Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia | Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis. | Baseline (Day 1), Day 3 up to Day 6 |
| Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3 | The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported. | Day 3 |
| Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3 | Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported. | Day 3 |
| Germany |
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. |
| BG002 | Placebo | Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2.
Glucagon: 1 mg administered via intramuscular injection on Day 3.
| OG002 | Placebo | Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. |
|
|
|
| Secondary | Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin | The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported. | All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data. | Posted | Mean | Standard Deviation | percentage of insulin units | Baseline (Day 1), Day 2 |
|
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021 | All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter | Predose (Day 2) through 120 hours postdose (Day 7) |
|
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021 | Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported. | All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms * hours per milliliter | Predose (Day 2) through 120 hours postdose (Day 7) |
|
|
|
| Secondary | Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period | Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis. | This outcome measure was not analyzed. | Posted | Baseline (Day 1), Day 3 up to Day 6 |
|
|
| Secondary | Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia | Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis. | This outcome measure was not analyzed. | Posted | Baseline (Day 1), Day 3 up to Day 6 |
|
|
| Secondary | Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3 | The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported. | All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams per deciliter | Day 3 |
|
|
|
|
| Secondary | Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3 | Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported. | All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data. | Posted | Geometric Mean | Geometric Coefficient of Variation | milligrams * minutes per deciliter | Day 3 |
|
|
|
|
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | 300 mg LY2409021 | LY2409021: 300 milligrams (mg), 3 capsules (3 X 100-mg capsules), administered as a single oral dose on Day 2. Glucagon: 1 mg administered via intramuscular injection on Day 3. | 0 | 8 | 6 | 8 |
| EG002 | Placebo | Placebo: 3 capsules administered as a single oral dose on Day 2. Glucagon: 1 milligram (mg) administered via intramuscular injection on Day 3. | 0 | 4 | 4 | 4 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Analysis was performed using the percent change in insulin dose, which takes into account absolute differences in individual insulin doses. The mean percent change on Day 2 from Day 1 in the 24-hour insulin dose for the placebo group was subtracted from each participant's percent change on Day 2 from Day 1 in the 24-hour insulin dose. This placebo adjusted 24-hour insulin dose was compared within the 300-mg LY2409021 dose group using a 1 sample t-test. | t-test, 1 sided | 0.0192 | Mean Difference (Net) | -19.6 | 2-Sided | 95 | -35.0 | -4.3 | Superiority or Other |
| t-test, 2 sided |
| 0.0048 |
| Mean Difference (Net) |
| -59 |
| 2-Sided |
| 95 |
| -96 |
| -23 |
| Superiority or Other |
Statistical analysis of the effect of LY2409021 treatment on area under the glucose concentration curve from time 0 to 2 hours postdose following an intramuscular injection of glucagon (1 milligram).
| t-test, 2 sided |
| 0.0046 |
| Mean Difference (Net) |
| -5187 |
| 2-Sided |
| 95 |
| -8371 |
| -2004 |
| Superiority or Other |