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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT04591626

Collaborator

(none)

291

Enrollment

Locations

Arms

16.7

Actual Duration (Months)

10.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Dulaglutide Drug: Placebo Drug: Insulin Glargine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

291 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 7, 2020

Actual Primary Completion Date :

Apr 28, 2022

Actual Study Completion Date :

Apr 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dulaglutide Dulaglutide administered subcutaneously (SC) in combination with insulin glargine given SC.	Drug: Dulaglutide Administered SC Other Names: LY2189265 Drug: Insulin Glargine Administered SC
Placebo Comparator: Placebo Placebo administered SC in combination with insulin glargine given SC.	Drug: Placebo Administered SC Drug: Insulin Glargine Administered SC

Arm

Intervention/Treatment

Experimental: Dulaglutide

Dulaglutide administered subcutaneously (SC) in combination with insulin glargine given SC.

Drug: Dulaglutide

Administered SC

Other Names:

LY2189265

Drug: Insulin Glargine

Administered SC

Placebo Comparator: Placebo

Placebo administered SC in combination with insulin glargine given SC.

Drug: Placebo

Administered SC

Drug: Insulin Glargine

Administered SC

Outcome Measures

Primary Outcome Measures

Change from Baseline in Hemoglobin A1c (HbA1c) [Baseline, Week 28]
Change from Baseline in HbA1c

Secondary Outcome Measures

Percentage of Participants achieving HbA1c <7.0% [Week 28]
Percentage of Participants achieving HbA1c <7.0%
Change from Baseline in Body Weight [Baseline, Week 28]
Change from Baseline in Body Weight
Change from Baseline in Fasting Serum Glucose (FSG) [Baseline, Week 28]
Change from Baseline in FSG
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)
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)
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)
Change From Baseline in Blood Glucose From Daily Self-Monitored Plasma Glucose (SMPG) Profile [Baseline, Week 28]
Change From Baseline in Blood Glucose From Daily SMPG Profile
Change From Baseline in Daily Mean Insulin Glargine Doses [Baseline, Week 28]
Change From Baseline in Daily Mean Insulin Glargine Doses

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second People's Hospital of Hefei	Hefei	Anhui	China	230011
2	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510120
3	First Affiliated Hospital of the Harbin Medical University	Harbin	Heilongjiang	China	150001
4	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
5	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan	China	471003
6	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou Shi	Henan	China	450014
7	Changzhou No.2 People's Hospital	Changzhou	Jiangsu	China	213003
8	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210000
9	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210011
10	The First Hospital of Nanjing	Nanjing	Jiangsu	China	210012
11	Nanjing Medical University - Nanjing Jiangning Hospital	Nanjing	Jiangsu	China	211100
12	No. 2 Affiliated Hospital of Suzhou University	Suzhou Shi	Jiangsu	China	215004
13	Wuxi People's Hospital	Wuxi	Jiangsu	China	214023
14	The Third Hospital of Nanchang	Nanchang	Jiangxi	China	330009
15	Pingxiang People's Hospital	Pingxiang	Jiangxi	China	337000
16	The First Hospital of Jilin University	Changchun	Jilin	China	130021
17	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning	China	116033
18	Jinan Central Hospital	Jinan	Shandong	China	250013
19	Shanghai Putuo District Center Hospital	Shanghai	Shanghai	China	200062
20	The First Affiliated Hospital of Xi'an Medical University	XI 'an	Shanxi	China	710077
21	West China Hospital Sichuan University	Chengdu	Sichuan	China	610041
22	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300052
23	The Affiliated Jiangyin Hospital of Southeast University Medical College	Wuxi Shi	Wuxi Shi	China	214400
24	The First People's Hospital of Yunnan Province	Kunming	Yunnan	China	650034
25	Chongqing General Hospital	Chongqing	Yuzhong District	China	400014
26	Zhejiang Hospital	Hangzhou	Zhejiang	China	310013
27	Beijing Pinggu District Hospital	Beijing		China	101200

Sponsors and Collaborators

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