Diabetes Mellitus, Type 2, Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
DRUGDulaglutide
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
All Participants: * Native Chinese (all 4 grandparents of Chinese origin) * Male participants with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. * The method of contraception may be one of the following: condom with spermicidal agent, male participant sterilization, true abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable). * Female participants not of child-bearing potential (i.e. are postmenopausal or permanently sterilized \[e.g. tubal occlusion, hysterectomy, bilateral salpingectomy\]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrollment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or at least 1 year of spontaneous amenorrhea, with follicle stimulating hormone (FSH) ≥40 milli international units per milliliter (mIU/mL). * Female participants who have undergone sterilization by tubal ligation: agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such participants must also test negative for pregnancy at the time of enrollment. Participants with T2DM: * Have T2DM controlled with diet or exercise alone or with a single oral agent antihyperglycemic medication (OAM) (metformin, sulfonylureas, meglitinides, acarbose \[or other disaccharidase inhibitors\] or thiazolidinediones) for at least 3 weeks (3 months for thiazolidinediones) before admission. Note that participants receiving sulfonylureas, meglitinides or acarbose may participate only if this treatment is stopped and metformin substituted. If switched to metformin, participants should be allowed to stabilize on metformin for 3 weeks before receiving study drug. * If T2DM controlled with diet or exercise alone, must have a hemoglobin A1c (HbA1c) value of 6.5% to 10.5% at screening and a fasting blood glucose value of 126 to 250 milligrams per deciliter (mg/dL) (approximately 7.0 to 13.9 millimoles per liter \[mmol/L\]) at screening. * If T2DM controlled with OAM(s), must have an HbA1c value of 9.0% or less at screening and a fasting blood glucose value of 110 to 200 mg/dL (approximately 6.1 to 11.1 mmol/L) at screening. If a participant's T2DM is being controlled with OAM(s) other than metformin, the participant's OAM will be stopped for at least 3 weeks before administration of study drug.
Exclusion criteria
All Participants: * Have a history or presence of cardiovascular (myocardial infarction, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, hematological, neurological autoimmune or endocrine (except T2DM), disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. * Have evidence of significant active neuropsychiatric disease. * Have poorly controlled hypertension (systolic \>160 millimeters of mercury \[mmHg\] and/or diastolic \>100 mmHg) and/or evidence of labile blood pressure including symptomatic postural hypotension. * Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts gastric empty (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase (DPP)-4 inhibitors. Participants with dyslipidemia, and participants who had cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may be included in the study at the discretion of the screening physician. * Have personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC. Participants with T2DM * Have experienced outpatient use of insulin for control of diabetes within the past 6 months. * Have clinically significant peripheral vascular occlusive disease in the opinion of the investigator. * Have known severe exudative diabetic retinopathy in the opinion of the investigator. * Have known significant autonomic neuropathy as evidenced by urinary retention, diabetic diarrhea, or gastroparesis. * Have experienced a ketoacidotic episode (pH less than 7.3) requiring hospitalization in the last 6 months. * Regular use of drugs that affect the glycodynamics and that directly reduce gastrointestinal motility (eg, anticholinergics, antispasmodics, 5HT3 antagonists, dopamine antagonists, and opiates) and of systemic corticosteroids by oral, intravenous, or intramuscular route, or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. |
| Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. |
| Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. |
| Pharmacokinetics: Half-life of Dulaglutide | Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose | Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Baseline and Days 3, 24, and 29 | Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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 | 11 |
| 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 | 11 |
| 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 | 10 |
| Placebo (Part B-T2DM) Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B | 10 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part B | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part A-Healthy | Total | Placebo (Part B-T2DM) | 1.5 mg Dulaglutide (Part B-T2DM) | 0.75 mg Dulaglutide (Part B-T2DM) | 0.5 mg Dulaglutide (Part B-T2DM) |
|---|---|---|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 5.6 | 48.4 years STANDARD_DEVIATION 14.5 | 51.8 years STANDARD_DEVIATION 8.3 | 55.8 years STANDARD_DEVIATION 8.5 | 56.9 years STANDARD_DEVIATION 13.1 | 58.2 years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 58 Participants | 10 Participants | 10 Participants | 11 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 58 Participants | 10 Participants | 10 Participants | 11 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 16 participants | 58 participants | 10 participants | 10 participants | 11 participants | 11 participants |
| Sex: Female, Male Female | 0 Participants | 12 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 16 Participants | 46 Participants | 7 Participants | 7 Participants | 8 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 16 | 0 / 10 | 2 / 11 | 4 / 11 | 1 / 10 | 5 / 11 | 5 / 11 | 2 / 10 |
| serious Total, serious adverse events | 0 / 16 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 10 | 1 / 11 | 0 / 11 | 0 / 10 |
Outcome results
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.
Time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
Population: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4) | 4500 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 42 |
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 22 (Part B only; n = 6, 10, 10 | NA nanograms*hours per milliliter (ng*h/mL) | — |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4) | 6410 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 14 |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 22 (Part B only; n = 6, 10, 10 | NA nanograms*hours per milliliter (ng*h/mL) | — |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4) | 11700 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 12 |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 22 (Part B only; n = 6, 10, 10 | NA nanograms*hours per milliliter (ng*h/mL) | — |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4) | 3900 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 7 |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 22 (Part B only; n = 6, 10, 10 | 4720 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 7 |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4) | 5490 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 19 |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 22 (Part B only; n = 6, 10, 10 | 7030 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 17 |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4) | 10300 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 16 |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide | Day 22 (Part B only; n = 6, 10, 10 | 12500 nanograms*hours per milliliter (ng*h/mL) | Geometric Coefficient of Variation 15 |
Primary
Pharmacokinetics: Half-life of Dulaglutide
Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
Time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
Population: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Half-life of Dulaglutide | Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4) | 85.1 hours |
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Half-life of Dulaglutide | Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9) | NA hours |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Half-life of Dulaglutide | Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4) | 84.5 hours |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Half-life of Dulaglutide | Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9) | NA hours |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Half-life of Dulaglutide | Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4) | 82.9 hours |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Half-life of Dulaglutide | Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9) | NA hours |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Half-life of Dulaglutide | Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4) | 122 hours |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Half-life of Dulaglutide | Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9) | 97.6 hours |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Half-life of Dulaglutide | Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4) | 113 hours |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Half-life of Dulaglutide | Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9) | 106 hours |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Half-life of Dulaglutide | Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4) | 88.5 hours |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Half-life of Dulaglutide | Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9) | 105 hours |
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.
Time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
Population: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 1 (Parts A and B) | 29.4 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 22 (Part B only) | NA nanograms per milliliter (ng/mL) | — |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 1 (Parts A and B) | 44.2 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 14 |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 22 (Part B only) | NA nanograms per milliliter (ng/mL) | — |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 1 (Parts A and B) | 81.5 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 21 |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 22 (Part B only) | NA nanograms per milliliter (ng/mL) | — |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 1 (Parts A and B) | 20.7 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 18 |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 22 (Part B only) | 26.3 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 27 |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 1 (Parts A and B) | 31.3 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 23 |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 22 (Part B only) | 41.4 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 18 |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 1 (Parts A and B) | 52.6 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 28 |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide | Day 22 (Part B only) | 70.2 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 19 |
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.
Time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
Population: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 1 (Parts A and B) | 48.02 hours |
| 0.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 22 (Part B only) | NA hours |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 1 (Parts A and B) | 48.00 hours |
| 0.75 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 22 (Part B only) | NA hours |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 1 (Parts A and B) | 48.00 hours |
| 1.5 mg Dulaglutide (Part A-Healthy) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 22 (Part B only) | NA hours |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 1 (Parts A and B) | 48.00 hours |
| 0.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 22 (Part B only) | 48.00 hours |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 1 (Parts A and B) | 48.00 hours |
| 0.75 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 22 (Part B only) | 47.98 hours |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 1 (Parts A and B) | 71.98 hours |
| 1.5 mg Dulaglutide (Part B-T2DM) | Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide | Day 22 (Part B only) | 48.00 hours |
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.
Time frame: Baseline and Days 3, 24, and 29
Population: Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Baseline | 44.3 millimoles*hours per liter (mmol*h/L) | Standard Deviation 10.6 |
| 0.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 3 | 34.2 millimoles*hours per liter (mmol*h/L) | Standard Deviation 6.19 |
| 0.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 24 | 34.7 millimoles*hours per liter (mmol*h/L) | Standard Deviation 7.11 |
| 0.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 29 | 37.6 millimoles*hours per liter (mmol*h/L) | Standard Deviation 9.11 |
| 0.75 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 29 | 38.1 millimoles*hours per liter (mmol*h/L) | Standard Deviation 7.4 |
| 0.75 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 24 | 36.8 millimoles*hours per liter (mmol*h/L) | Standard Deviation 7.08 |
| 0.75 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 3 | 41.2 millimoles*hours per liter (mmol*h/L) | Standard Deviation 11.9 |
| 0.75 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Baseline | 58.1 millimoles*hours per liter (mmol*h/L) | Standard Deviation 11.7 |
| 1.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 24 | 30.5 millimoles*hours per liter (mmol*h/L) | Standard Deviation 4.55 |
| 1.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 29 | 31.8 millimoles*hours per liter (mmol*h/L) | Standard Deviation 4.57 |
| 1.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 3 | 32.2 millimoles*hours per liter (mmol*h/L) | Standard Deviation 4.87 |
| 1.5 mg Dulaglutide (Part A-Healthy) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Baseline | 53.4 millimoles*hours per liter (mmol*h/L) | Standard Deviation 8.12 |
| 0.5 mg Dulaglutide (Part B-T2DM) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 29 | 46.9 millimoles*hours per liter (mmol*h/L) | Standard Deviation 6.68 |
| 0.5 mg Dulaglutide (Part B-T2DM) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Baseline | 48.2 millimoles*hours per liter (mmol*h/L) | Standard Deviation 7 |
| 0.5 mg Dulaglutide (Part B-T2DM) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 3 | 46.1 millimoles*hours per liter (mmol*h/L) | Standard Deviation 8.94 |
| 0.5 mg Dulaglutide (Part B-T2DM) | Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4]) | Day 24 | 48.6 millimoles*hours per liter (mmol*h/L) | Standard Deviation 9.1 |