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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-MC-GBDR | Other Identifier | Eli Lilly and Company |
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LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes mellitus. This study will compare the concentrations of LY2189265 using different methods of administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV - into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The purpose of this study is to look at how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given by the methods above. The study is divided into three parts, Part A, B and C. Volunteers will only be able to participate in one part. All Participants in Part A will receive a single IV dose of up to 0.1 milligram (mg). Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg). Part B of the study will occur after Part A because the dose of IV drug will depend on the results of Part A. Part B of the study may not occur if the volunteers in Part A do not tolerate the drug. Participants in Part C will also be given drug twice by an SC injection and an IM injection, both doses will be 0.75 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY2189265 intravenous | Experimental | Single intravenous (IV) dose, starting at 0.1 milligrams (mg) of LY2189265. Dose may be increased to 0.2 mg or decreased to 0.05 mg for subsequent patients, dependent on safety assessments of the first 3 patients. |
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| Part B: LY2189265 subcutaneous, intravenous | Experimental | Patients are randomized to 2 sequences of 2 treatments. Single 1.5 mg subcutaneous (SC) dose of LY2189265 in Period 1; single intravenous (IV) dose of LY2189265 (determined by Part A IV arm data) in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods. |
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| Part C: LY2189265 subcutaneous, intramuscular | Experimental | Patients are randomized to 2 sequences of 2 treatments. Single 0.75 mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75 mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There is a washout period of at least 4 weeks between dosing periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2189265 | Biological | administered intravenous, subcutaneous or intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV) | AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. | Predose up to 336 hours postdose |
| Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV) | The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. | Predose up to 336 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC) | AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. | Predose up to 336 hours postdose |
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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. | Evansville | Indiana |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: LY2189265 Intravenous | Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265. |
| FG001 | Part B: LY2189265 Subcutaneous, Intravenous | Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods. |
| FG002 | Part C: LY2189265 Subcutaneous, Intramuscular | Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: LY2189265 Intravenous | Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265 |
| BG001 | Part B: LY2189265 Subcutaneous, Intravenous | Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV) | AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. | Participants in Part B who had pharmacokinetic (PK) data. | Geometric Mean | 90% Confidence Interval | nanograms*hour/milliliter/milligram | Predose up to 336 hours postdose |
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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 | Part A: 0.1 mg IV LY2189265 | Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal 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 |
|---|---|
| C555680 | dulaglutide |
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| )Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC) |
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. |
| Predose up to 336 hours postdose |
| United States |
| BG002 | Part C: LY2189265 Subcutaneous, Intramuscular | Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV) | The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. | Participants in Part B who had pharmacokinetic (PK) data. | Geometric Mean | 90% Confidence Interval | nanograms/milliliter (ng/mL) | Predose up to 336 hours postdose |
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| Secondary | Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC) | AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. | Participants in Part C who had pharmacokinetic (PK) data. | Geometric Mean | 90% Confidence Interval | nanograms*hour/milliliter (ng*h/mL) | Predose up to 336 hours postdose |
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| Secondary | )Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC) | The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error. | Participants in Part C who had pharmacokinetic (PK) data. | Geometric Mean | 90% Confidence Interval | nanograms/milliliter (ng/mL) | Predose up to 336 hours postdose |
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| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Part B: 0.1 mg IV LY2189265 | Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2. | 0 | 16 | 7 | 16 |
| EG002 | Part B: 1.5 mg SC LY2189265 | Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2. | 0 | 16 | 9 | 16 |
| EG003 | Part C: 0.75 mg IM LY2189265 | Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2. | 0 | 8 | 3 | 8 |
| EG004 | Part C: 0.75 mg SC LY2189265 | Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2. | 0 | 8 | 2 | 8 |
| 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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| Toothache | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Extravasation | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Vessel puncture site haematoma | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Candidiasis | Infections and infestations | 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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| Decreased appetite | 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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| 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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| Dysaesthesia | 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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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| D004700 | Endocrine System Diseases |