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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Dulaglutide in Chinese Participants

NCTNCT01667900 (opens ClinicalTrials.gov in a new tab)Other id12925Other idH9X-EW-GBDL

Overview

Status
Completed
Phase
Phase 1
Enrollment
58 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
Aug 2012
Primary completion
Jun 2014
Completion
Jun 2014
First posted
17 Aug 2012 (estimated)
Last update posted
7 Mar 2016 (estimated)
Conditions
Diabetes Mellitus, Type 2 · Healthy Volunteers

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 1

    A Study of Dulaglutide in Chinese Participants

    NCT01667900

    Aug 2012 to Jun 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • DulaglutideDrug
  • PlaceboDrug

Arms8

  • Experimental

    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

  • Experimental

    0.75 mg Dulaglutide (Part A-Healthy)

    0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods

  • Experimental

    1.5 mg Dulaglutide (Part A-Healthy)

    1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods

  • Placebo comparator

    Placebo (Part A-Healthy)

    Placebo administered once SQ to healthy participants in 1 of 3 treatment periods

  • Experimental

    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

  • Experimental

    0.75 mg Dulaglutide (Part B-T2DM)

    0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks

  • Experimental

    1.5 mg Dulaglutide (Part B-T2DM)

    1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks

  • Placebo comparator

    Placebo (Part B-T2DM)

    Placebo administered to participants with T2DM once weekly SQ for 4 weeks

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide

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

    Registry description

    Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.

  2. 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

    Registry description

    Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.

  3. 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

    Registry description

    Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.

  4. Pharmacokinetics: Half-life of Dulaglutide

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

    Registry description

    Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.

Secondary outcomes(1)
  1. 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

    Registry description

    Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide

GroupValue (nanograms per milliliter (ng/mL))Spread
0.5 mg Dulaglutide (Part A-Healthy)29.439
0.75 mg Dulaglutide (Part A-Healthy)44.214
1.5 mg Dulaglutide (Part A-Healthy)81.521
0.5 mg Dulaglutide (Part B-T2DM)20.718
0.75 mg Dulaglutide (Part B-T2DM)31.323
1.5 mg Dulaglutide (Part B-T2DM)52.628
Primary outcomeMedian· Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

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

GroupValue (hours)
0.5 mg Dulaglutide (Part A-Healthy)48.02
0.75 mg Dulaglutide (Part A-Healthy)48.00
1.5 mg Dulaglutide (Part A-Healthy)48.00
0.5 mg Dulaglutide (Part B-T2DM)48.00
0.75 mg Dulaglutide (Part B-T2DM)48.00
1.5 mg Dulaglutide (Part B-T2DM)71.98
Primary outcomeGeometric mean· 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

GroupValue (nanograms*hours per milliliter (ng*h/mL))Spread
0.5 mg Dulaglutide (Part A-Healthy)450042
0.75 mg Dulaglutide (Part A-Healthy)641014
1.5 mg Dulaglutide (Part A-Healthy)1170012
0.5 mg Dulaglutide (Part B-T2DM)39007
0.75 mg Dulaglutide (Part B-T2DM)549019
1.5 mg Dulaglutide (Part B-T2DM)1030016
Primary outcomeGeometric mean· Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose

Pharmacokinetics: Half-life of Dulaglutide

GroupValue (hours)
0.5 mg Dulaglutide (Part A-Healthy)85.1
0.75 mg Dulaglutide (Part A-Healthy)84.5
1.5 mg Dulaglutide (Part A-Healthy)82.9
0.5 mg Dulaglutide (Part B-T2DM)122
0.75 mg Dulaglutide (Part B-T2DM)113
1.5 mg Dulaglutide (Part B-T2DM)88.5
Secondary and other outcome results(1)
Secondary outcomeMean· Baseline and Days 3, 24, and 29

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

GroupValue (millimoles*hours per liter (mmol*h/L))Spread
0.5 mg Dulaglutide (Part B-T2DM)44.310.6
0.75 mg Dulaglutide (Part B-T2DM)58.111.7
1.5 mg Dulaglutide (Part B-T2DM)53.48.12
Placebo (Part B-T2DM48.27.00

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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.–0 / 161 / 16
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 / 100 / 10
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 / 112 / 11
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 / 114 / 11
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 / 101 / 10
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 / 115 / 11
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 / 115 / 11
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 / 102 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

19 results

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.

Xu et al. 2022Advances in therapycited by 10

PMID 34787823DOI 10.1007/s12325-021-01921-5PUB-34787823

Full text at the publisher19 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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