GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1Results posted

A Study of Dulaglutide in Chinese Participants

Pharmacokinetics of a Single Dulaglutide Dose in Healthy Chinese Subjects and of Multiple Dulaglutide Doses in Chinese Patients With T2DM

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-10.5%

Primary endpoints

•Cmax of Dulaglutide•Time of Cmax (Tmax) of Dulaglutide•AUC From Time Zero

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01667900

Org study ID12925

Secondary IDH9X-EW-GBDLEli Lilly and Company

Timeline

Milestones

Study first posted2012-08-17estimated

Last update posted2016-03-07estimated

Results first posted2016-03-07estimated

Study start2012-08 (month precision)

Primary completion2014-06actual (month precision)

Study completion2014-06actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Healthy volunteersType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Secondary/registry result

Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])

Time frame:Baseline and Days 3, 24, and 29

Postprandial glucose

descriptive

Posted result

Group	Value (mean), millimoleshours per liter (mmolh/L)	95% CI
0.5 mg Dulaglutide (Part B-T2DM)Baseline	44.3	—
Day 3	34.2	—
Day 24	34.7	—
Day 29	37.6	—
0.75 mg Dulaglutide (Part B-T2DM)Baseline	58.1	—
Day 3	41.2	—
Day 24	36.8	—
Day 29	38.1	—
1.5 mg Dulaglutide (Part B-T2DM)Baseline	53.4	—
Day 3	32.2	—
Day 24	30.5	—
Day 29	31.8	—
Placebo (Part B-T2DMBaseline	48.2	—
Day 3	46.1	—
Day 24	48.6	—
Day 29	46.9	—

Secondary/protocol endpoint

Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])

Time frame:Baseline and Days 3, 24, and 29

Postprandial glucose

change from baseline, improvement

Safety / tolerability / PK

8 endpoints

Primary/registry result

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanograms per milliliter (ng/mL)	95% CI
0.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B)	29.4	—
Day 22 (Part B only)	NA	—
0.75 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B)	44.2	—
Day 22 (Part B only)	NA	—
1.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B)	81.5	—
Day 22 (Part B only)	NA	—
0.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B)	20.7	—
Day 22 (Part B only)	26.3	—
0.75 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B)	31.3	—
Day 22 (Part B only)	41.4	—
1.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B)	52.6	—
Day 22 (Part B only)	70.2	—

Primary/registry result

Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Tmax

concentration, descriptive

Posted result

Group	Value (median), hours	95% CI
0.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B)	48.02	12.02 – 48.02
Day 22 (Part B only)	NA	NA – NA
0.75 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B)	48.00	24.00 – 48.00
Day 22 (Part B only)	NA	NA – NA
1.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B)	48.00	24.00 – 48.00
Day 22 (Part B only)	NA	NA – NA
0.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B)	48.00	47.92 – 72.00
Day 22 (Part B only)	48.00	12.00 – 48.02
0.75 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B)	48.00	24.00 – 72.00
Day 22 (Part B only)	47.98	24.00 – 48.00
1.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B)	71.98	24.00 – 96.00
Day 22 (Part B only)	48.00	23.97 – 96.00

Primary/registry result

Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanogramshours per milliliter (ngh/mL)	95% CI
0.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)	4500	—
Day 22 (Part B only; n = 6, 10, 10	NA	—
0.75 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)	6410	—
Day 22 (Part B only; n = 6, 10, 10	NA	—
1.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)	11700	—
Day 22 (Part B only; n = 6, 10, 10	NA	—
0.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)	3900	—
Day 22 (Part B only; n = 6, 10, 10	4720	—
0.75 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)	5490	—
Day 22 (Part B only; n = 6, 10, 10	7030	—
1.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)	10300	—
Day 22 (Part B only; n = 6, 10, 10	12500	—

Primary/registry result

Pharmacokinetics: Half-life of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Half-life

descriptive

Posted result

Group	Value (geometric_mean), hours	95% CI
0.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)	85.1	50.8 – 244
Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)	NA	NA – NA
0.75 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)	84.5	60.2 – 228
Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)	NA	NA – NA
1.5 mg Dulaglutide (Part A-Healthy)Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)	82.9	63.8 – 104
Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)	NA	NA – NA
0.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)	122	106 – 133
Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)	97.6	71.9 – 122
0.75 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)	113	63.9 – 222
Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)	106	70.4 – 139
1.5 mg Dulaglutide (Part B-T2DM)Day 1 (Parts A and B; n=6, 10, 11, 3, 8, 4)	88.5	69.6 – 111
Day 22 (Part B only; n=NA, NA, NA, 6, 10, 9)	105	80.0 – 134

Primary/protocol endpoint

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Cmax

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Tmax

descriptive

Primary/protocol endpoint

Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics: Half-life of Dulaglutide

Time frame:Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Half-life

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
Advances in therapy2022 Jan (month)PMID34787823doi:10.1007/s12325-021-01921-5via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.