A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes
NCT ID: NCT04591626
Last Updated: 2023-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
291 participants
INTERVENTIONAL
2020-12-07
2022-04-28
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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1.5 Milligrams (mg) Dulaglutide
Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose.
Dulaglutide
Administered SC
Insulin Glargine
Administered SC
Placebo
Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Placebo
Administered SC
Insulin Glargine
Administered SC
Interventions
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Dulaglutide
Administered SC
Placebo
Administered SC
Insulin Glargine
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* are men or nonpregnant women aged ≥18 years at screening
* have been treated with basal insulin glargine once daily and metformin and/or acarbose for at least 3 months prior to screening
* doses of once daily insulin glargine and OAMs must be stable during the 3-month period prior to screening. Insulin glargine dose is considered stable when all doses during this period are within the range defined by ±20% of the most commonly used insulin glargine dose during this same period. Doses of metformin and/or acarbose are considered stable when doses are unchanged during the same period, and the doses should be in the inclusive range of the half maximum to maximum approved daily dose per the locally-approved label
* have an HbA1c value ≥7.0% and ≤11.0% as assessed by the central laboratory at screening
* require further insulin glargine dose increase at baseline per the TTT algorithm based on the SMBG data (FBG ≥5.6mmol/L) collected during the prior week
* have stable weight (±5%) ≥3 months prior to screening
* have body mass index (BMI) between ≥19.0 and ≤35.0 kg/m2 at screening
Exclusion Criteria
* have a history of ≥1 episode of ketoacidosis or hyperosmolar state/coma
* have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
* have had any of the following CV conditions within the 2 months prior to screening: acute myocardial infarction (MI), New York Heart Association (NYHA) Class III or Class IV heart failure, or cerebrovascular accident (stroke)
* have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone or plan to have a gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility
* have a history of chronic pancreatitis or acute idiopathic pancreatitis, or were diagnosed with any type of acute pancreatitis within the 3 months prior to screening
* for participants on metformin or metformin and acarbose, have renal disease or renal dysfunction (eGFR \[CKD-EPI\] \<45 mL/min/1.73 m2), as determined by the central laboratory; for participants on acarbose, have renal disease or renal dysfunction (eGFR \[CKD-EPI\] \<25 mL/min/1.73 m2), as determined by the central laboratory
* have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) syndrome in the absence of known C-cell hyperplasia (the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B syndrome have a known RET mutation and the potential participant for the study is negative for the RET mutation)
* have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
* have serum calcitonin ≥20 pg/mL at screening, as determined by the central laboratory
* have any hematologic condition that may interfere with HbA1c measurement (eg, hemolytic anemias, sickle-cell disease)
* have been treated with any other antihyperglycemia regimen, other than basal insulin glargine once daily and metformin and/or acarbose, within the 3 months prior to screening or between screening and baseline
18 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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The Second People's Hospital of Hefei
Hefei, Anhui, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
First Affiliated Hospital of the Harbin Medical University
Harbin, Heilongjiang, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Hospital of Nanjing
Nanjing, Jiangsu, China
Nanjing Medical University - Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
No. 2 Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai Putuo District Center Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
Wuxi, Wuxi Shi, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Chongqing General Hospital
Chongqing, Yuzhong District, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Beijing Pinggu District Hospital
Beijing, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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H9X-MC-GBGO
Identifier Type: OTHER
Identifier Source: secondary_id
17731
Identifier Type: -
Identifier Source: org_study_id
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