Diabetes Mellitus, Type 2Phase 1NCT01667900

A Study of Dulaglutide in Chinese Participants

A Phase 1 study testing Dulaglutide in people with Diabetes Mellitus, Type 2 and Healthy Volunteers, run by Eli Lilly and Company at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2, Healthy Volunteers
What is being tested?: Dulaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteChina
Study dates: Aug 2012to Jun 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

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.

Conditions: Diabetes Mellitus, Type 2, Healthy Volunteers
Being tested: Dulaglutide, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DulaglutideDrug
Also called LY2189265
PlaceboDrug
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.

Study groups in NCT01667900
Study group	Role	What they receive
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 Receives: Drug: Dulaglutide; Drug: Placebo
0.75 mg Dulaglutide (Part A-Healthy)	Experimental	0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods Receives: Drug: Dulaglutide; Drug: Placebo
1.5 mg Dulaglutide (Part A-Healthy)	Experimental	1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods Receives: Drug: Dulaglutide; Drug: Placebo
Placebo (Part A-Healthy)	Placebo comparator	Placebo administered once SQ to healthy participants in 1 of 3 treatment periods Receives: Drug: Placebo
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 Receives: Drug: Dulaglutide; Drug: Placebo
0.75 mg Dulaglutide (Part B-T2DM)	Experimental	0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks Receives: Drug: Dulaglutide; Drug: Placebo
1.5 mg Dulaglutide (Part B-T2DM)	Experimental	1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks Receives: Drug: Dulaglutide; Drug: Placebo
Placebo (Part B-T2DM)	Placebo comparator	Placebo administered to participants with T2DM once weekly SQ for 4 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide
Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Secondary outcomes (1)

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.
Measured: Baseline and Days 3, 24, and 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jun 2014

First posted17 Aug 2012 (estimated)
Study startAug 2012
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01667900
Sponsor's protocol ID: 12925
Other IDs: H9X-EW-GBDL
Status last verified: Feb 2016
First submitted: 15 Aug 2012
Last updated: 7 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 34787823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of a Single Dulaglutide Dose in Healthy Chinese Subjects and of Multiple Dulaglutide Doses in Chinese Patients With T2DM
ClinicalTrials.gov ID: NCT01667900
Acronym / sponsor ID: 12925
Conditions: Diabetes Mellitus, Type 2, Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 17 Aug 2012 (estimated)
Results: Posted 7 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Doses of 0.5 milligrams (mg), 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
0.5 mg Dulaglutide (Part A-Healthy)	Experimental	Drug: Dulaglutide, Drug: Placebo0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods
0.75 mg Dulaglutide (Part A-Healthy)	Experimental	Drug: Dulaglutide, Drug: Placebo0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
1.5 mg Dulaglutide (Part A-Healthy)	Experimental	Drug: Dulaglutide, Drug: Placebo1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Placebo (Part A-Healthy)	Placebo comparator	Drug: PlaceboPlacebo administered once SQ to healthy participants in 1 of 3 treatment periods
0.5 mg Dulaglutide (Part B-T2DM)	Experimental	Drug: Dulaglutide, Drug: Placebo0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks
0.75 mg Dulaglutide (Part B-T2DM)	Experimental	Drug: Dulaglutide, Drug: Placebo0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
1.5 mg Dulaglutide (Part B-T2DM)	Experimental	Drug: Dulaglutide, Drug: Placebo1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Placebo (Part B-T2DM)	Placebo comparator	Drug: PlaceboPlacebo administered to participants with T2DM once weekly SQ for 4 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DulaglutideAlso: LY2189265	Drug	0.5 mg Dulaglutide (Part A-Healthy), 0.5 mg Dulaglutide (Part B-T2DM), 0.75 mg Dulaglutide (Part A-Healthy), 0.75 mg Dulaglutide (Part B-T2DM), 1.5 mg Dulaglutide (Part A-Healthy), 1.5 mg Dulaglutide (Part B-T2DM)
PlaceboAdministered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.	Drug	0.5 mg Dulaglutide (Part A-Healthy), 0.5 mg Dulaglutide (Part B-T2DM), 0.75 mg Dulaglutide (Part A-Healthy), 0.75 mg Dulaglutide (Part B-T2DM), 1.5 mg Dulaglutide (Part A-Healthy), 1.5 mg Dulaglutide (Part B-T2DM), Placebo (Part A-Healthy), Placebo (Part B-T2DM)

Primary outcome

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 7 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)	1	1
First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)	1	1
First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)	1	1
First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)	1	1
First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)	1	1
First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)	1	1
First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)	1	1
First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)	1	1
First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)	1	1
First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)	1	1
First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)	1	1
First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)	1	1
First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)	1	1
First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)	1	1
First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)	1	1
First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)	1	1
0.5 mg Dulaglutide (Part B-T2DM)	0	0
0.75 mg Dulaglutide (Part B-T2DM)	0	0
1.5 mg Dulaglutide (Part B-T2DM)	0	0
Placebo (Part B-T2DM)	0	0

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide

Time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	0.5 mg Dulaglutide (Part A-Healthy) n = 10	0.75 mg Dulaglutide (Part A-Healthy) n = 11	1.5 mg Dulaglutide (Part A-Healthy) n = 11	0.5 mg Dulaglutide (Part B-T2DM) n = 11	0.75 mg Dulaglutide (Part B-T2DM) n = 11	1.5 mg Dulaglutide (Part B-T2DM) n = 10
Day 1 (Parts A and B)	29.4 (39)	44.2 (14)	81.5 (21)	20.7 (18)	31.3 (23)	52.6 (28)
Day 22 (Part B only)	NA (NA)	NA (NA)	NA (NA)	26.3 (27)	41.4 (18)	70.2 (19)

Population analysed: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.

Primary outcome: 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. Median (Full Range). Unit: hours

Measure	0.5 mg Dulaglutide (Part A-Healthy) n = 10	0.75 mg Dulaglutide (Part A-Healthy) n = 11	1.5 mg Dulaglutide (Part A-Healthy) n = 11	0.5 mg Dulaglutide (Part B-T2DM) n = 11	0.75 mg Dulaglutide (Part B-T2DM) n = 11	1.5 mg Dulaglutide (Part B-T2DM) n = 10
Day 1 (Parts A and B)	48.02 (12.02 to 48.02)	48.00 (24.00 to 48.00)	48.00 (24.00 to 48.00)	48.00 (47.92 to 72.00)	48.00 (24.00 to 72.00)	71.98 (24.00 to 96.00)
Day 22 (Part B only)	NA (NA to NA)	NA (NA to NA)	NA (NA to NA)	48.00 (12.00 to 48.02)	47.98 (24.00 to 48.00)	48.00 (23.97 to 96.00)

Population analysed: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms*hours per milliliter (ng*h/mL)

Measure	0.5 mg Dulaglutide (Part A-Healthy) n = 10	0.75 mg Dulaglutide (Part A-Healthy) n = 11	1.5 mg Dulaglutide (Part A-Healthy) n = 11	0.5 mg Dulaglutide (Part B-T2DM) n = 11	0.75 mg Dulaglutide (Part B-T2DM) n = 11	1.5 mg Dulaglutide (Part B-T2DM) n = 10
Day 1 (Parts A and B; n = 6, 10, 11, 3, 8, 4)	4500 (42)	6410 (14)	11700 (12)	3900 (7)	5490 (19)	10300 (16)
Day 22 (Part B only; n = 6, 10, 10	NA (NA)	NA (NA)	NA (NA)	4720 (7)	7030 (17)	12500 (15)

Population analysed: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.

Primary outcome: Pharmacokinetics: Half-life of Dulaglutide

Time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose. Geometric mean (Full Range). Unit: hours

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

Population analysed: Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part A-Healthy)	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
0.5 mg Dulaglutide (Part A-Healthy)	0 of 10 (0%)	0 of 10 (0%)	Not reported
0.75 mg Dulaglutide (Part A-Healthy)	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
1.5 mg Dulaglutide (Part A-Healthy)	0 of 11 (0%)	4 of 11 (36.4%)	Not reported
Placebo (Part B-T2DM)	0 of 10 (0%)	1 of 10 (10%)	Not reported
0.5 mg Dulaglutide (Part B-T2DM)	1 of 11 (9.1%)	5 of 11 (45.5%)	Not reported
0.75 mg Dulaglutide (Part B-T2DM)	0 of 11 (0%)	5 of 11 (45.5%)	Not reported
1.5 mg Dulaglutide (Part B-T2DM)	0 of 10 (0%)	2 of 10 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34787823Xu 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dulaglutide in people with Diabetes Mellitus, Type 2 and Healthy Volunteers, run by Eli Lilly and Company at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide (time frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01667900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.