A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes (AWARD-CHN3)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: Dulaglutide; Drug: Insulin Glargine

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 101200
    • Beijing Pinggu District Hospital
  • Anhui
    • Hefei, Anhui, China, 230011
      • The Second People's Hospital of Hefei
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150001
      • First Affiliated Hospital of the Harbin Medical University
  • Henan
    • Luoyang Shi, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou Shi, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    • Nanjing, Jiangsu, China, 210012
      • The First Hospital of Nanjing
    • Nanjing, Jiangsu, China, 211100
      • Nanjing Medical University - Nanjing Jiangning Hospital
    • Suzhou Shi, Jiangsu, China, 215004
      • No. 2 Affiliated Hospital of Suzhou University
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330009
      • The Third Hospital of Nanchang
    • Pingxiang, Jiangxi, China, 337000
      • Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116033
      • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200062
      • Shanghai Putuo District Center Hospital
  • Shanxi
    • XI 'an, Shanxi, China, 710077
      • The First Affiliated Hospital of Xi'an Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Tianjin Medical University General Hospital
  • Wuxi Shi
    • Wuxi Shi, Wuxi Shi, China, 214400
      • The Affiliated Jiangyin Hospital of Southeast University Medical College
  • Yunnan
    • Kunming, Yunnan, China, 650034
      • The First People's Hospital of Yunnan Province
  • Yuzhong District
    • Chongqing, Yuzhong District, China, 400014
      • Chongqing General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310013
      • Zhejiang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Dulaglutide; Administered SC; Other Names: LY2189265; Drug: Insulin Glargine; Administered SC
Placebo Comparator: 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.	Drug: Placebo; Administered SC; Drug: Insulin Glargine; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)	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.	Baseline, Week 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving HbA1c <7.0%	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.	Week 28
Change From Baseline in Body Weight	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.	Baseline, Week 28
Change From Baseline in Fasting Serum Glucose (FSG)	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.	Baseline, 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)	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.	Week 28
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)	Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L) was reported here.	Week 28
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)	Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg) was reported here.	Week 28
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile	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.	Baseline, Week 28
Change From Baseline in Daily Mean Insulin Glargine Doses	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.	Baseline, Week 28

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: October 16, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: T2DM; LY2189265
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide; Insulin Glargine
• Other Study ID Numbers: 17731; H9X-MC-GBGO (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes