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| ID | Type | Description | Link |
|---|---|---|---|
| I3P-FW-GKBE | Other Identifier | Eli Lilly and Company |
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Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes. Study subjects will receive once daily doses of LY2608204 for a total treatment duration of up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until reaching the highest dose that they can tolerate.
Continuous glucose monitoring devices will be employed for each patient to monitor for hypoglycemia during study treatment. Dose titration and dose reduction is determined for each individual patient based on their safety and glycemic data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2608204 | Experimental | Oral capsules of LY2608204 given once daily at a starting dose of 160 milligram (mg), which may be titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2608204 | Drug | Administered orally. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Adverse Effects | Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product. | Day 1 through Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Time Curve (AUC) | AUC for Day 1 is AUC from 0 to 24 hours. AUC for all other days is AUC at a dosing interval. | Predose, 1, 2, 4, 6, 7, 10, 12 and 24 hours Postdose |
| Maximum Drug Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for EU/UK/US Site(s) only --
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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. | Miramar | Florida | 33025 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2608204 | Oral capsules of LY2608204 given once daily at a starting dose of 160 mg, which was titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2608204 | Oral capsules of LY2608204 given once daily at a starting dose of 160 mg, which was titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment. |
| 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 Clinically Significant Adverse Effects | Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product. | Participants who were administered study drug. | Posted | Count of Participants | Participants | No | Day 1 through Day 49 |
|
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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 | 160 mg LY2608204 | Oral capsules of LY2608204 given once daily at dose of 160 milligram (mg) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 13.1 | 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 |
|---|---|
| C000712893 | globalagliatin |
| C520311 | glucokinase activator compound 50 |
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| Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose |
| Time to Maximum Drug Concentration (Tmax) | Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose |
| Number of Hypoglycemic Events | Number of hypoglycemia events with blood glucose concentration <70 milligram/deciliter (mg/dL). | Day 1 through Day 29 |
| 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. | Singapore | 117597 | Singapore |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Fasting Blood Glucose (FBG) | Mean | Standard Deviation | milligram/deciliter (mg/dL) |
|
| Glycated Hemoglobin (HbA1c) | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| OG002 | 320 mg LY2608204 | Oral capsules of LY2608204 given once daily at dose of 320 mg |
| OG003 | 400 mg LY2608204 | Oral capsules of LY2608204 given once daily at dose of 400 mg |
|
|
| Secondary | Area Under the Concentration Time Curve (AUC) | AUC for Day 1 is AUC from 0 to 24 hours. AUC for all other days is AUC at a dosing interval. | Participants who were administered study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram.hour/milliliter (ng.hr/mL) | Predose, 1, 2, 4, 6, 7, 10, 12 and 24 hours Postdose |
|
|
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| Secondary | Maximum Drug Concentration (Cmax) | Participants who were administered study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/mL) | Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose |
|
|
|
| Secondary | Time to Maximum Drug Concentration (Tmax) | Participants who were administered study drug. | Posted | Median | Full Range | hour | Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose |
|
|
|
| Secondary | Number of Hypoglycemic Events | Number of hypoglycemia events with blood glucose concentration <70 milligram/deciliter (mg/dL). | Participants who were administered study drug. | Posted | Number | events | Day 1 through Day 29 |
|
|
|
| 0 |
| 20 |
| 9 |
| 20 |
| EG001 | 240 mg LY2608204 | Oral capsules of LY2608204 given once daily at dose of 240 mg | 0 | 20 | 8 | 20 |
| EG002 | 320 mg LY2608204 | Oral capsules of LY2608204 given once daily at dose of 320 mg | 0 | 19 | 9 | 19 |
| EG003 | 400 mg LY2608204 | Oral capsules of LY2608204 given once daily at dose of 400 mg | 0 | 17 | 8 | 17 |
| Conjunctival haemorrhage | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |