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| ID | Type | Description | Link |
|---|---|---|---|
| H9X-EW-GBDL | Other Identifier | Eli Lilly and Company |
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This is a study of dulaglutide in Chinese participants. The purpose of the study is to determine how the body processes dulaglutide and how dulaglutide affects the body. This study has 2 parts: Part A - single dose of dulaglutide administered to healthy participants in 2 of 3 study periods. There is a minimum 28-day washout between periods. Part A will last approximately 16 weeks. Part B - multiple doses of dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM). Part B will last approximately 15 weeks.
Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg Dulaglutide (Part A-Healthy) | Experimental | 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods |
|
| 0.75 mg Dulaglutide (Part A-Healthy) | Experimental | 0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods |
|
| 1.5 mg Dulaglutide (Part A-Healthy) | Experimental | 1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods |
|
| Placebo (Part A-Healthy) | Placebo Comparator | Placebo administered once SQ to healthy participants in 1 of 3 treatment periods |
|
| 0.5 mg Dulaglutide (Part B-T2DM) | Experimental | 0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dulaglutide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
| Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
| Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
| Pharmacokinetics: Half-life of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B. | Baseline and Days 3, 24, and 29 |
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Inclusion Criteria:
All Participants:
Participants with T2DM:
Exclusion Criteria:
All Participants:
Participants with T2DM
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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. | Beijing | 100034 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34787823 | Derived | Xu J, Zhang Y, Li Y, Zhao X, Zhou W, Loghin C, Tham LS, Cui X, Cui Y, Wang W. Pharmacokinetics, Pharmacodynamics, and Safety of Dulaglutide After Single or Multiple Doses in Chinese Healthy Subjects and Patients with T2DM: A Randomized, Placebo-Controlled, Phase I Study. Adv Ther. 2022 Jan;39(1):488-503. doi: 10.1007/s12325-021-01921-5. Epub 2021 Nov 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) Period 2: placebo administered once SQ Period 3: 1.5 mg dulaglutide administered once SQ |
| FG001 | First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.75 mg dulaglutide administered once SQ Period 2: 0.5 mg dulaglutide administered once SQ Period 3: placebo administered once SQ |
| FG002 | First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.75 mg dulaglutide administered once SQ Period 2: 1.5 mg dulaglutide administered once SQ Period 3: placebo administered once SQ |
| FG003 | First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.5 mg dulaglutide administered once SQ Period 2: 1.5 mg dulaglutide administered once SQ Period 3: placebo administered once SQ |
| FG004 | First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 1.5 mg dulaglutide administered once SQ Period 2: placebo administered once SQ Period 3: 0.75 mg dulaglutide administered once SQ |
| FG005 | First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: placebo administered once SQ Period 2: 0.5 mg dulaglutide administered once SQ Period 3: 1.5 mg dulaglutide administered once SQ |
| FG006 | First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.75 mg dulaglutide administered once SQ Period 2: placebo administered once SQ Period 3: 1.5 mg dulaglutide administered once SQ |
| FG007 | First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: placebo administered once SQ Period 2: 0.75 mg dulaglutide administered once SQ Period 3: 0.5 mg dulaglutide administered once SQ |
| FG008 | First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: placebo administered once SQ Period 2: 0.75 mg dulaglutide administered once SQ Period 3: 1.5 mg dulaglutide administered once SQ |
| FG009 | First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.5 mg dulaglutide administered once SQ Period 2: 0.75 mg dulaglutide administered once SQ Period 3: placebo administered once SQ |
| FG010 | First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 1.5 mg dulaglutide administered once SQ Period 2: 0.75 mg dulaglutide administered once SQ Period 3: placebo administered once SQ |
| FG011 | First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.5 mg dulaglutide administered once SQ Period 2: placebo administered once SQ Period 3: 0.75 mg dulaglutide administered once SQ |
| FG012 | First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 0.75 mg dulaglutide administered once SQ Period 2: placebo administered once SQ Period 3: 0.5 mg dulaglutide administered once SQ |
| FG013 | First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: placebo administered once SQ Period 2: 1.5 mg dulaglutide administered once SQ Period 3: 0.75 mg dulaglutide administered once SQ |
| FG014 | First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: 1.5 mg dulaglutide administered once SQ Period 2: 0.5 mg dulaglutide administered once SQ Period 3: placebo administered once SQ |
| FG015 | First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy) | Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses. Period 1: placebo administered once SQ Period 2: 1.5 mg dulaglutide administered once SQ Period 3: 0.5 mg dulaglutide administered once SQ |
| FG016 | 0.5 mg Dulaglutide (Part B-T2DM) | 0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B |
| FG017 | 0.75 mg Dulaglutide (Part B-T2DM) | 0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| FG018 | 1.5 mg Dulaglutide (Part B-T2DM) | 1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| FG019 | Placebo (Part B-T2DM) | Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A, Period 1 |
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| Part A, Washout 1 |
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| Part A, Period 2 |
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| Part A, Washout 2 |
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| Part A, Period 3 |
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| Part B |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A-Healthy | Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses. |
| 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 | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
|
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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 (Part A-Healthy) | Placebo administered once SQ to healthy participants in 1 of 3 treatment periods Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system 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 |
|---|---|
| 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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| 0.75 mg Dulaglutide (Part B-T2DM) | Experimental | 0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks |
|
| 1.5 mg Dulaglutide (Part B-T2DM) | Experimental | 1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks |
|
| Placebo (Part B-T2DM) | Placebo Comparator | Placebo administered to participants with T2DM once weekly SQ for 4 weeks |
|
|
| Placebo | Drug | Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. |
|
| China |
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | 0.5 mg Dulaglutide (Part B-T2DM) | 0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| BG002 | 0.75 mg Dulaglutide (Part B-T2DM) | 0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| BG003 | 1.5 mg Dulaglutide (Part B-T2DM) | 1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| BG004 | Placebo (Part B-T2DM) | Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| BG005 | 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 | Number | participants |
|
| OG002 | 1.5 mg Dulaglutide (Part A-Healthy) | 1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A |
| OG003 | 0.5 mg Dulaglutide (Part B-T2DM) | 0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| OG004 | 0.75 mg Dulaglutide (Part B-T2DM) | 0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
| OG005 | 1.5 mg Dulaglutide (Part B-T2DM) | 1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B |
|
|
| Primary | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data. | Posted | Median | Full Range | hours | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours per milliliter (ng*h/mL) | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
|
|
|
| Primary | Pharmacokinetics: Half-life of Dulaglutide | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. | Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data. | Posted | Geometric Mean | Full Range | hours | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose |
|
|
|
| Secondary | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B. | Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data. | Posted | Mean | Standard Deviation | millimoles*hours per liter (mmol*h/L) | Baseline and Days 3, 24, and 29 |
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | 0.5 mg Dulaglutide (Part A-Healthy) | 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods Dulaglutide Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. | 0 | 10 | 0 | 10 |
| EG002 | 0.75 mg Dulaglutide (Part A-Healthy) | 0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods Dulaglutide Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. | 0 | 11 | 2 | 11 |
| EG003 | 1.5 mg Dulaglutide (Part A-Healthy) | 1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods Dulaglutide Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. | 0 | 11 | 4 | 11 |
| EG004 | Placebo (Part B-T2DM) | Placebo administered to participants with T2DM once weekly SQ for 4 weeks Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. | 0 | 10 | 1 | 10 |
| EG005 | 0.5 mg Dulaglutide (Part B-T2DM) | 0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks Dulaglutide Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. | 1 | 11 | 5 | 11 |
| EG006 | 0.75 mg Dulaglutide (Part B-T2DM) | 0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks Dulaglutide Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. | 0 | 11 | 5 | 11 |
| EG007 | 1.5 mg Dulaglutide (Part B-T2DM) | 1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks Dulaglutide Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms. | 0 | 10 | 2 | 10 |
| Atrial tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Heart rate abnormal | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| Day 22 (Part B only) |
|
| Day 22 (Part B only; n = 6, 10, 10 |
|
| Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9) |
|
| Day 3 |
|
| Day 24 |
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| Day 29 |
|