- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02750410
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
September 16, 2019 updated by: Eli Lilly and Company
A Phase 4 Study of Efficacy and Safety of Dulaglutide When Added to Insulin Treatment With or Without Oral Antidiabetic Medication in Patients With Type 2 Diabetes
The main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in Japanese participants with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
159
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Adachi-ku, Japan, 123-0845
- 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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Chiba, Japan, 2610004
- 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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Chiyoda, Japan, 102-0082
- 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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Chuo-ku, Japan, 103-0027
- 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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Chuo-ku, Japan, 103-0028
- 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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Chuou-ku, Japan, 1030002
- 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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Fuchu, Japan, 183-8524
- 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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Ichikawa, Japan, 272-8516
- 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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Isahaya, Japan, 8548501
- 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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Kamakura, Japan, 247-0056
- 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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Kashihara, Japan, 634-8522
- 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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Kumamoto, Japan, 862-0965
- 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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Kumamoto, Japan, 862-0976
- 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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Maebashi-City, Japan, 3710821
- 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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Mito, Japan, 310-0845
- 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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Naka, Japan, 311-0113
- 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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Nishinomiya, Japan, 662-0971
- 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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Ooita, Japan, 870-0039
- 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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Osaka, Japan, 530-0001
- 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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Sasebo, Japan, 857-1195
- 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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Shimotsuke, Japan, 329-0433
- 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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Shizuoka, Japan, 424-0855
- 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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Tama, Japan, 206-0633
- 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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Toda, Japan, 335-0023
- 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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Yokohama, Japan, 241-0821
- 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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants who have had a diagnosis of type 2 diabetes mellitus
- Participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (OADs) at stable dose for at least 3 months before screening
- Participants who have an HbA1c value ≥7.0% and ≤10.5% at screening if the participant is washing out OADs (dipeptidyl peptidase-4 [DPP-4] inhibitors, sulfonylurea [SU], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out OADs
- Participants who have stable weight (±5%) ≥3 months prior to screening
- Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m^2)
Exclusion Criteria:
- Participants who have a diagnosis of type 1 diabetes
- Participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening
- Participants who have been previously treated with dulaglutide prior to screening
- Participants who have been treated with 2 of the following at screening: DPP-4 inhibitor, SU, and glinide (ie, DPP-4 inhibitor and SU, or DPP-4 inhibitor and glinide)
- Participants who have been treated with continuous subcutaneous insulin infusion (CSII) at screening
- Participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities
- Participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Dulaglutide
Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks.
After 16-weeks, dulaglutide administered once weekly for 36 weeks.
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Administered subcutaneously (SC)
Other Names:
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Placebo Comparator: Placebo
Placebo administered once weekly for 16 weeks.
After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks.
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Administered SC
Administered subcutaneously (SC)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 16
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HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
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Baseline, Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With HbA1c <7.0% or ≤6.5%
Time Frame: Week 16
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Percentage of participants whose HbA1c was <7.0% or ≤6.5%.
HbA1c <7.0% is presented.
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Week 16
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Change From Baseline in Fasting Serum Glucose (FSG)
Time Frame: Baseline, Week 16
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The LS mean change from baseline in FSG was calculated using a REML based MMRM and adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c Group (<8.5%, >=8.5%) + insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
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Baseline, Week 16
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Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)
Time Frame: Baseline, Week 16
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The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: prebreakfast blood glucose (BG), breakfast 2-hour postprandial blood glucose (PPBG), prelunch BG, lunch 2-hour PPBG, predinner BG, dinner 2-hour PPBG, and bedtime BG.
LS mean was calculated with fixed effect test of analysis of covariance (ANCOVA) model and adjusted by, baseline value, treatment, baseline HbA1c Group (<8.5%, ≥8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin).
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Baseline, Week 16
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Change From Baseline in Body Weight
Time Frame: Baseline, Week 16
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LS mean change from baseline in body weight was calculated using a REML based MMRM and was adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c group (<8.5%, >=8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.
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Baseline, Week 16
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Change From Baseline in Daily Total Insulin Dose
Time Frame: Baseline, Week 16
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Mean change from baseline in total insulin dose was measured in each treatment groups.
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Baseline, Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Onishi Y, Ishii H, Oura T, Takeuchi M. Efficacy and Safety of Once-Weekly Dulaglutide in Type 2 Diabetes Patients Using Insulin: Exploratory Subgroup Analysis by Insulin Regimen. Diabetes Ther. 2020 Mar;11(3):735-745. doi: 10.1007/s13300-020-00765-6. Epub 2020 Jan 29.
- Ishii H, Onishi Y, Oura T, Takeuchi M. Once-Weekly Dulaglutide with Insulin Therapy for Type 2 Diabetes: Efficacy and Safety Results from a Phase 4, Randomized, Placebo-Controlled Study. Diabetes Ther. 2020 Jan;11(1):133-145. doi: 10.1007/s13300-019-00726-8. Epub 2019 Nov 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Actual)
June 18, 2018
Study Completion (Actual)
June 18, 2018
Study Registration Dates
First Submitted
April 21, 2016
First Submitted That Met QC Criteria
April 21, 2016
First Posted (Estimate)
April 25, 2016
Study Record Updates
Last Update Posted (Actual)
September 24, 2019
Last Update Submitted That Met QC Criteria
September 16, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15803
- H9X-JE-GBGF (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
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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