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Type 2 Diabetes MellitusPhase 3AWARD-CHN3NCT04591626

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

A Phase 3 study testing Dulaglutide and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 27 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Dulaglutide and Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
291 participants
Where
27 sitesChina
Study dates
7 Dec 2020to 28 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • Beijing Pinggu District Hospital

    Beijing, 101200

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213003

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing General Hospital

    Chongqing, Yuzhong District, 400014

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning, 116033

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

    Guangzhou, Guangdong, 510120

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310013

  • First Affiliated Hospital of the Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Second People's Hospital of Hefei

    Hefei, Anhui, 230011

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650034

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan, 471003

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi, 330009

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

    Nanjing, Jiangsu, 210000

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • The First Hospital of Nanjing

    Nanjing, Jiangsu, 210012

  • Nanjing Medical University - Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 211100

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

  • Shanghai Putuo District Center Hospital

    Shanghai, Shanghai Municipality, 200062

  • No. 2 Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215004

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023

  • The Affiliated Jiangyin Hospital of Southeast University Medical College

    Wuxi, Wuxi Shi, 214400

  • The First Affiliated Hospital of Xi'an Medical University

    Xi’an, Shanxi, 710077

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

Other trials in China

About this study

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

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.

Being tested
Dulaglutide, Placebo, Insulin Glargine
Keywords
T2DM, LY2189265
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DulaglutideDrug

    Also called LY2189265

    Administered SC

  • PlaceboDrug

    Administered SC

  • Insulin GlargineDrug

    Administered SC

Study groups in NCT04591626
Study groupRoleWhat they receive
1.5 Milligrams (mg) DulaglutideExperimentalParticipants 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.
Receives: Drug: Dulaglutide; Drug: Insulin Glargine
PlaceboPlacebo comparatorParticipants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Receives: Drug: Placebo; Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 28

Secondary outcomes (8)

  1. 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.

    Measured: Week 28

  2. 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.

    Measured: Baseline, Week 28

  3. 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.

    Measured: Baseline, Week 28

  4. 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.

    Measured: Week 28

  5. 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.

    Measured: Week 28

  6. 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.

    Measured: Week 28

  7. 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.

    Measured: Baseline, Week 28

  8. 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.

    Measured: Baseline, Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start7 Dec 2020
  3. Primary completion28 Apr 2022
  4. Study completion28 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
291 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04591626
Sponsor's protocol ID
17731
Other IDs
H9X-MC-GBGO
Acronym
AWARD-CHN3
Status last verified
Apr 2023
First submitted
16 Oct 2020
Last updated
24 May 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide and Insulin Glargine in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 27 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04591626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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