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| ID | Type | Description | Link |
|---|---|---|---|
| I6K-FW-GLEB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the safety of LY2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. It also aims to determine how long the drug stays in the body and how it affects blood sugar levels. A screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Multiple oral dose of placebo administered to participants with diabetes once or twice daily for 28 days |
|
| LY2922470 | Experimental | Multiple ascending dose of LY292470 (starting at 60 mg) administered orally to participants with diabetes once or twice daily for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Administered orally as capsules |
| |
| LY2922470 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module. | Baseline through Study Completion (up to 56 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose | |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 |
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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. | Chula Vista | California | 91911 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo QD or BID | Placebo administered orally once daily (QD) or twice daily (BID) for up to 28 days. |
| FG001 | 60 mg LY2922470 QD | 60 mg LY2922470 administered orally QD for up to 28 days. |
| FG002 | 200 mg LY2922470 QD | 200 mg LY2922470 administered orally QD for up to 28 days. |
| FG003 | 500 mg LY2922470 QD | 500 mg LY2922470 administered orally QD for up to 28 days. |
| FG004 | 1200 mg LY2922470 QD | 1200 mg LY2922470 administered orally QD for up to 28 days. |
| FG005 | 150 mg LY2922470 BID | 150 mg LY2922470 administered orally BID for up to 28 days. |
| FG006 | 400 mg LY2922470 BID | 400 mg LY2922470 administered orally BID for up to 28 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo QD or BID | Placebo administered orally QD or BID for up to 28 days. |
| BG001 | 60 mg LY2922470 QD | 60 mg LY2922470 administered orally QD for up to 28 days. |
| 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 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through Study Completion (up to 56 days) |
|
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All participants who received at least one dose of study drug.
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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 | Placebo QD or BID | Placebo administered orally QD or BID for up to 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenopia | Eye disorders | MedDRA 16.0 | 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 |
|---|---|
| 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 |
|---|---|
| C000620333 | LY2922470 |
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| Drug |
Administered orally as capsules |
|
| Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose |
| Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose |
| Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | Baseline, Day 28 |
| Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose |
| Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose |
| United States |
| 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. | Eatontown | New Jersey | 07724 | United States |
| 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. | New York | New York | 10013 | United States |
| 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. | Dallas | Texas | 75247 | United States |
| Physician Decision |
|
| Unable to Place Catheter for Blood Draws |
|
| BG002 | 200 mg LY2922470 QD | 200 mg LY2922470 administered orally QD for up to 28 days. |
| BG003 | 500 mg LY2922470 QD | 500 mg LY2922470 administered orally QD for up to 28 days. |
| BG004 | 1200 mg LY2922470 QD | 1200 mg LY2922470 administered orally QD for up to 28 days. |
| BG005 | 150 mg LY2922470 BID | 150 mg LY2922470 administered orally BID for up to 28 days. |
| BG006 | 400 mg LY2922470 BID | 400 mg LY2922470 administered orally BID for up to 28 days. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms per square meter (kg/m²) |
|
| Hemoglobin A1c (HbA1c) | HbA1c is a form of hemoglobin that is primarily measured to identify the average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Fasting Blood Glucose | Mean | Standard Deviation | milligrams per deciliter (mg/dL) |
|
| OG002 | 200 mg LY2922470 QD | 200 mg LY2922470 administered orally QD for up to 28 days. |
| OG003 | 500 mg LY2922470 QD | 500 mg LY2922470 administered orally QD for up to 28 days. |
| OG004 | 1200 mg LY2922470 QD | 1200 mg LY2922470 administered orally QD for up to 28 days. |
| OG005 | 150 mg LY2922470 BID | 150 mg LY2922470 administered orally BID for up to 28 days. |
| OG006 | 400 mg LY2922470 BID | 400 mg LY2922470 administered orally BID for up to 28 days. |
|
|
| Secondary | Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470 | All participants who received LY2922470 and had sufficient evaluable AUC(0-24) values. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour/milliliter (ng*h/mL) | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470 | All participants who received LY2922470 and had sufficient evaluable Cmax values. For BID arms, Cmax from time 0-6 hours. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose |
|
|
|
| Secondary | Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470 | All participants who received LY2922470 and had sufficient evaluable Tmax values. For BID arms, Tmax from time 0-6 hours. | Posted | Median | Full Range | hours | Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose |
|
|
|
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28 | All participants who received study drug and had sufficient evaluable HbA1c values. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Baseline, Day 28 |
|
|
|
| Secondary | Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀-₂₄) During Mixed Meal Tolerance Test at Day 28 | All participants who received study drug and had sufficient evaluable blood glucose values. | Posted | Mean | Standard Deviation | mg*h/dL | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose |
|
|
|
| Secondary | Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀-₁₂) During Mixed Meal Tolerance Test at Day 28 | All participants who received study drug and had sufficient evaluable c-peptide values. | Posted | Mean | Standard Deviation | picomoles*h per liter (pmol*h/L) | Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose |
|
|
|
| 0 |
| 14 |
| 5 |
| 14 |
| EG001 | 60 mg LY2922470 QD | 60 mg LY2922470 administered orally QD for up to 28 days. | 0 | 8 | 3 | 8 |
| EG002 | 200 mg LY2922470 QD | 200 mg LY2922470 administered orally QD for up to 28 days. | 0 | 8 | 4 | 8 |
| EG003 | 500 mg LY2922470 QD | 500 mg LY2922470 administered orally QD for up to 28 days. | 0 | 8 | 4 | 8 |
| EG004 | 1200 mg LY2922470 QD | 1200 mg LY2922470 administered orally QD for up to 28 days. | 0 | 9 | 5 | 9 |
| EG005 | 150 mg LY2922470 BID | 150 mg LY2922470 administered orally BID for up to 28 days. | 0 | 8 | 1 | 8 |
| EG006 | 400 mg LY2922470 BID | 400 mg LY2922470 administered orally BID for up to 28 days. | 0 | 9 | 6 | 9 |
| Vitreous floaters | Eye disorders | MedDRA 16.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Faeces pale | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 16.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
|
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
|
| Nipple disorder | Reproductive system and breast disorders | MedDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
|
| Day 28 |
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|
| Day 28 |
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| Day 28 |
|
|