A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT04591626
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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. 1.5 Milligrams (mg) Dulaglutide 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. 1.5 Milligrams (mg) Dulaglutide Insulin Glargine 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. Placebo Insulin Glargine Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
- Primary Outcome Measures
Name Time Method Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 28 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Oral Antihyperglycemic Medications (OAM) use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Fasting Serum Glucose (FSG) Baseline, Week 28 Change from baseline in FSG was reported here. LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
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) Week 28 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) was reported here.
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L) Week 28 Percentage of Participants Achieving HbA1c \<7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg) Week 28 Percentage of Participants Achieving HbA1c \<7.0% Without Weight Gain (\<0.1 kg) was reported here.
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile Baseline, Week 28 The SMBG data was collected at the following 7 time points: Pre morning meal BG, 2-hour postprandial measurement for morning meal BG, Pre midday meal BG, 2-hour postprandial measurement for midday meal BG, Pre evening meal BG, 2-hour postprandial measurement for evening meals BG, and Bedtime BG. LS mean was determined using MMRM model with Baseline + OAM (metformin and/or acarbose) usage + HbA1c Group at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Change From Baseline in Daily Mean Insulin Glargine Doses Baseline, Week 28 LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
Percentage of Participants Achieving HbA1c <7.0% Week 28 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Odds Ratio (OR) was determined using longitudinal logistic regression model with Baseline HbA1c value + OAM use + Treatment + Visit + Treatment\*Visit as variables.
Change From Baseline in Body Weight Baseline, Week 28 Change from baseline in body weight was reported here. LS mean was determined by MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.
Trial Locations
- Locations (27)
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou Shi, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Changzhou No.2 People's Hospital
🇨🇳Changzhou, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Shanghai Putuo District Center Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi'an Medical University
🇨🇳XI 'an, Shanxi, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The Affiliated Jiangyin Hospital of Southeast University Medical College
🇨🇳Wuxi Shi, Wuxi Shi, China
The First People's Hospital of Yunnan Province
🇨🇳Kunming, Yunnan, China
Chongqing General Hospital
🇨🇳Chongqing, Yuzhong District, China
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China
First Affiliated Hospital of the Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Nanjing Medical University - Nanjing Jiangning Hospital
🇨🇳Nanjing, Jiangsu, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Beijing Pinggu District Hospital
🇨🇳Beijing, China
No. 2 Affiliated Hospital of Suzhou University
🇨🇳Suzhou Shi, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, 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
Zhejiang Hospital
🇨🇳Hangzhou, Zhejiang, China