Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Dulaglutide in Chinese Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01667900
First received: August 15, 2012
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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 two 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 mg, 0.75 mg, and 1.5 mg of dulaglutide will be evaluated in this study.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Healthy Volunteers
Drug: Dulaglutide
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of a Single Dulaglutide Dose in Healthy Chinese Subjects and of Multiple Dulaglutide Doses in Chinese Patients With T2DM

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Maximum concentration (Cmax) of dulaglutide [ Time Frame: Baseline, 12, 24, 48, 72, 96, 168, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Time of maximum observed concentration (Tmax) of dulaglutide [ Time Frame: Baseline, 12, 24, 48, 72, 96, 168, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) of dulaglutide [ Time Frame: Baseline, 12, 24, 48, 72, 96, 168, and 336 hours post dose ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Half-life of dulaglutide [ Time Frame: Baseline, 12, 24, 48, 72, 96, 168, and 336 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part B - Pharmacodynamics: Area under the plasma glucose time curve (gAUC) [ Time Frame: Baseline and Days 3, 24, and 29 ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 mg Dulaglutide (Part A-Healthy)
0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Drug: Dulaglutide
Administered SQ.
Other Name: LY2189265
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Experimental: 0.75 mg Dulaglutide (Part A-Healthy)
0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Drug: Dulaglutide
Administered SQ.
Other Name: LY2189265
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Experimental: 1.5 mg Dulaglutide (Part A-Healthy)
1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods
Drug: Dulaglutide
Administered SQ.
Other Name: LY2189265
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Placebo Comparator: Placebo (Part A-Healthy)
Placebo administered once SQ to healthy participants in 1 of 3 treatment periods
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Experimental: 0.5 mg Dulaglutide (Part B-T2DM)
0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Drug: Dulaglutide
Administered SQ.
Other Name: LY2189265
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Experimental: 0.75 mg Dulaglutide (Part B-T2DM)
0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Drug: Dulaglutide
Administered SQ.
Other Name: LY2189265
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Experimental: 1.5 mg Dulaglutide (Part B-T2DM)
1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks
Drug: Dulaglutide
Administered SQ.
Other Name: LY2189265
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
Placebo Comparator: Placebo (Part B-T2DM)
Placebo administered to participants with T2DM once weekly SQ for 4 weeks
Drug: Placebo
Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 micromoles 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667900

Locations
China
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, China, 100034
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01667900     History of Changes
Other Study ID Numbers: 12925, H9X-EW-GBDL
Study First Received: August 15, 2012
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014