- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667900
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Beijing, China, 100034
- 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.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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
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Other Names:
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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Experimental: 0.75 mg Dulaglutide (Part A-Healthy)
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
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Other Names:
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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Experimental: 1.5 mg Dulaglutide (Part A-Healthy)
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
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Other Names:
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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Placebo Comparator: Placebo (Part A-Healthy)
Placebo administered once SQ to healthy participants in 1 of 3 treatment periods
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Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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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
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Other Names:
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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Experimental: 0.75 mg Dulaglutide (Part B-T2DM)
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
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Other Names:
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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Experimental: 1.5 mg Dulaglutide (Part B-T2DM)
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
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Other Names:
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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Placebo Comparator: Placebo (Part B-T2DM)
Placebo administered to participants with T2DM once weekly SQ for 4 weeks
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Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide
Time Frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
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Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
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Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
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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
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Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
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Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
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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
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Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
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Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
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Pharmacokinetics: Half-life of Dulaglutide
Time Frame: Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
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Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.
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Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.
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Baseline and Days 3, 24, and 29
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12925
- H9X-EW-GBDL (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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