Clinical trial NCT04591626: A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes
Official title: A Randomized, Double-Blind Trial Comparing the Effect of the Addition of Dulaglutide 1.5 mg Versus the Addition of Placebo to Titrated Basal Insulin on Glycemic Control in Chinese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: T2DM
LY2189265
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-10-19
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and efficacy of once weekly dulaglutide when added to insulin glargine, with metformin and/or acarbose in Chinese participants with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* have type 2 diabetes
* 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 type 1 diabetes (T1D)
* 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 28
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1c <7.0%
timeFrame: Week 28
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 28
measure: Change From Baseline in Fasting Serum Glucose (FSG)
timeFrame: Baseline, Week 28
measure: Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)
timeFrame: Week 28
measure: Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)
timeFrame: Week 28
measure: Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)
timeFrame: Week 28
measure: Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile
timeFrame: Baseline, Week 28
measure: Change From Baseline in Daily Mean Insulin Glargine Doses
timeFrame: Baseline, Week 28
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Harbin
country: China
facility: First Affiliated Hospital of the Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou Shi
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The First Hospital of Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University - Nanjing Jiangning Hospital
state: Jiangsu
city: Suzhou Shi
country: China
facility: No. 2 Affiliated Hospital of Suzhou University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
state: Jiangxi
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University
state: Liaoning
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Putuo District Center Hospital
state: Shanghai
city: XI 'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Wuxi Shi
country: China
facility: The Affiliated Jiangyin Hospital of Southeast University Medical College
state: Wuxi Shi
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Chongqing
country: China
facility: Chongqing General Hospital
state: Yuzhong District
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: