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A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03315780
Recruitment Status : Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the glucodynamic effects of dulaglutide in Japanese participants with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dulaglutide Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 4 Study to Evaluate Glucodynamic Effects of Dulaglutide in Japanese Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : October 28, 2017
Estimated Primary Completion Date : March 19, 2018
Estimated Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dulaglutide, Placebo
Dulaglutide and placebo administered subcutaneously (SQ).
Drug: Dulaglutide
Administered SQ
Other Name: LY2189265
Drug: Placebo
Administered SQ
Experimental: Placebo, Dulaglutide
Placebo and dulaglutide administered SQ.
Drug: Dulaglutide
Administered SQ
Other Name: LY2189265
Drug: Placebo
Administered SQ


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline in Glucose Area Under the Concentration Versus Time Curve from Time Zero to 4 Hours (AUC[0-4h]) [ Time Frame: Baseline, 4 Weeks ]
    Change from baseline in glucose AUC(0-4h)


Secondary Outcome Measures :
  1. Change from Baseline in Fasting Blood Glucose [ Time Frame: Baseline, 4 Weeks ]
    Change from baseline in fasting blood glucose

  2. Change from Baseline in Postprandial Blood Glucose [ Time Frame: Baseline, 4 Weeks ]
    Change from baseline in postprandial blood glucose

  3. Change from Baseline in Insulin [ Time Frame: Baseline, 4 Weeks ]
    Change from baseline in insulin

  4. Change from Baseline in C-Peptide [ Time Frame: Baseline, 4 Weeks ]
    Change from baseline in c-peptide

  5. Change from Baseline in Glucagon [ Time Frame: Baseline, 4 Weeks ]
    Change from baseline in glucagon

  6. Change from Baseline in Triglyceride [ Time Frame: Baseline, 4 Weeks ]
    Change from baseline in triglyceride

  7. Number of Participants who Develop Hypoglycemic Events [ Time Frame: Baseline through 4 weeks ]
    Number of participants who develop hypoglycemic events


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have type 2 diabetes (based on the World Health Organization [WHO] diagnostic criteria) for at least 1 year.
  • Have diet and exercise therapy only (no oral antihyperglycemic medication for at least 3 months prior to screening).
  • Have a fasting blood glucose value of ≥120 and ≤200 milligrams per deciliter (mg/dL) at screening.
  • Have a screening body weight of ≥50 and ≤80 kilograms.

Exclusion Criteria:

  • Have known allergies to dulaglutide, or other glucagon-like peptide-1 (GLP-1) receptor agonists.
  • Have had a clinically significant cardiovascular disease.
  • Have a known clinically significant gastric emptying abnormality or have undergone gastric bypass surgery or restrictive bariatric surgery.
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease.
  • Have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis.
  • Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 meter squared.
  • In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315780


Locations
Japan
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.
Fukuoka, Japan, 812-0025
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03315780     History of Changes
Other Study ID Numbers: 16730
H9X-JE-GBGK ( Other Identifier: Eli Lilly and Company )
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dulaglutide
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors