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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04591626
Recruitment Status : Completed
First Posted : October 19, 2020
Results First Posted : May 24, 2023
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : December 7, 2020
Actual Primary Completion Date : April 28, 2022
Actual Study Completion Date : April 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1.5 Milligrams (mg) Dulaglutide
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
Administered SC
Other Name: LY2189265

Drug: Insulin Glargine
Administered SC
Placebo Comparator: Placebo
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
Administered SC

Drug: Insulin Glargine
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  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) [ 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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 Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591626


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] July 30, 2020
Statistical Analysis Plan  [PDF] June 29, 2022

More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04591626    
Other Study ID Numbers: 17731
H9X-MC-GBGO ( Other Identifier: Eli Lilly and Company )
First Posted: October 19, 2020    Key Record Dates
Results First Posted: May 24, 2023
Last Update Posted: May 24, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eli Lilly and Company:
T2DM
LY2189265
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin Glargine
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs