A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes
NCT ID: NCT02750410
Last Updated: 2019-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
159 participants
INTERVENTIONAL
2016-08-31
2018-06-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dulaglutide
Dulaglutide 0.75 milligram (mg) administered once weekly for 16 weeks. After 16-weeks, dulaglutide administered once weekly for 36 weeks.
Dulaglutide
Administered subcutaneously (SC)
Placebo
Placebo administered once weekly for 16 weeks. After 16-weeks, dulaglutide 0.75 mg administered once weekly for 36 weeks.
Dulaglutide
Administered subcutaneously (SC)
Placebo
Administered SC
Interventions
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Dulaglutide
Administered subcutaneously (SC)
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Adachi-ku, , 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.
Chiba, , 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.
Chiyoda City, , Japan
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Chuou-ku, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Fuchū, , Japan
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Ichikawa, , Japan
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Isahaya, , Japan
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Kamakura, , Japan
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Kashihara, , Japan
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Kumamoto, , Japan
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Kumamoto, , Japan
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Maebashi, , Japan
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Mito, , Japan
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Naka, , Japan
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Nishinomiya, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Sasebo, , Japan
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Shimotsuke, , Japan
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Shizuoka, , Japan
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Tama, , 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.
Toda, , 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.
Yokohama, , Japan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H9X-JE-GBGF
Identifier Type: OTHER
Identifier Source: secondary_id
15803
Identifier Type: -
Identifier Source: org_study_id
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