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

NCT04591626 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 17731H9X-MC-GBGO
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 27

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

T2DM; LY2189265

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Percentage of Participants Achieving HbA1c <7.0%

  Week 28

• Change From Baseline in Body Weight

  Baseline, Week 28

• Change From Baseline in Fasting Serum Glucose (FSG)

  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)

  Week 28

• Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)

  Week 28

Study Arms (2)

1.5 Milligrams (mg) Dulaglutide

EXPERIMENTAL

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; Drug: Insulin Glargine

Placebo

PLACEBO COMPARATOR

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; Drug: Insulin Glargine

Interventions

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

1.5 Milligrams (mg) Dulaglutide

Placebo DRUG

Administered SC

Placebo

Insulin Glargine DRUG

Administered SC

1.5 Milligrams (mg) Dulaglutide; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (27)

The Second People's Hospital of Hefei

Hefei, Anhui, 230011, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

First Affiliated Hospital of the Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Henan, 471003, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

Location

Changzhou No.2 People's Hospital

Changzhou, Jiangsu, 213003, China

Location

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

The First Hospital of Nanjing

Nanjing, Jiangsu, 210012, China

Location

Nanjing Medical University - Nanjing Jiangning Hospital

Nanjing, Jiangsu, 211100, China

Location

No. 2 Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215004, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

Location

The Third Hospital of Nanchang

Nanchang, Jiangxi, 330009, China

Location

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, 116033, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Shanghai Putuo District Center Hospital

Shanghai, Shanghai Municipality, 200062, China

Location

The First Affiliated Hospital of Xi'an Medical University

Xi’an, Shanxi, 710077, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

The Affiliated Jiangyin Hospital of Southeast University Medical College

Wuxi, Wuxi Shi, 214400, China

Location

The First People's Hospital of Yunnan Province

Kunming, Yunnan, 650034, China

Location

Chongqing General Hospital

Chongqing, Yuzhong District, 400014, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

Location

Beijing Pinggu District Hospital

Beijing, 101200, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 19, 2020
• Study Start: December 7, 2020
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CN (27)