DRUG
Dulaglutide
Administered SC
Status
Completed
Phase
Phase 3
Enrollment
291
Locations
27
Results
Posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Oct 19, 2020
Study start
Dec 7, 2020
Primary completion
Apr 28, 2022
Study completion
Apr 28, 2022
Results posted
May 24, 2023
Registry updated
May 24, 2023
Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c)
Time frame · 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.
Percentage of Participants Achieving HbA1c <7.0%
Time frame · 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
Time frame · 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.
Change From Baseline in Fasting Serum Glucose (FSG)
Time frame · 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)
Time frame · 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)
Time frame · 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)
Time frame · 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
Time frame · 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
Time frame · 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.
Eligibility
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
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
No PMID-linked publications were present in this registry snapshot.
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