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

Type 2 Diabetes Mellitus Clinical Trial

— AWARD-CHN3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591626
• Other study ID #: 17731
• Secondary ID: H9X-MC-GBGO
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2020
• Est. completion date: April 28, 2022

Study information

• Verified date: April 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dulaglutide
Administered SC
• Placebo
Administered SC
• Insulin Glargine
Administered SC

Locations

Country	Name	City	State
China	Beijing Pinggu District Hospital	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Chongqing General Hospital	Chongqing	Yuzhong District
China	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	First Affiliated Hospital of the Harbin Medical University	Harbin	Heilongjiang
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second People's Hospital of Hefei	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Nanjing Medical University - Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	The First Hospital of Nanjing	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shanghai Putuo District Center Hospital	Shanghai	Shanghai
China	No. 2 Affiliated Hospital of Suzhou University	Suzhou Shi	Jiangsu
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The Affiliated Jiangyin Hospital of Southeast University Medical College	Wuxi Shi	Wuxi Shi
China	The First Affiliated Hospital of Xi'an Medical University	XI 'an	Shanxi
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou Shi	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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