Current partner codePEPTIDESDE
NCT04591626·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

291

Locations

27

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Dulaglutide

Administered SC

DRUG

Placebo

Administered SC

DRUG

Insulin Glargine

Administered SC

Timeline

From registration to results.

  1. First posted

    Oct 19, 2020

  2. Study start

    Dec 7, 2020

  3. Primary completion

    Apr 28, 2022

  4. Study completion

    Apr 28, 2022

  5. Results posted

    May 24, 2023

  6. Registry updated

    May 24, 2023

Outcomes

What the study measures.

Primary 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.

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

27 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.