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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name AWARD-CHN3

NCTNCT04591626 (opens ClinicalTrials.gov in a new tab)Other id17731Other idH9X-MC-GBGO

Overview

Status
Completed
Phase
Phase 3
Enrollment
291 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

China

Start
7 Dec 2020
Primary completion
28 Apr 2022
Completion
28 Apr 2022
First posted
19 Oct 2020
Last update posted
24 May 2023
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 3

    AWARD-CHN3

    NCT04591626

    7 Dec 2020 to 28 Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • DulaglutideDrug
  • PlaceboDrug
  • Insulin GlargineDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame · Baseline, Week 28

    Registry description

    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(8)
  1. Percentage of Participants Achieving HbA1c <7.0%

    Time frame · Week 28

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Hemoglobin A1c (HbA1c)

GroupValue (Percentage of HbA1c)Spread
1.5 mg Dulaglutide-2.030.076
Placebo-1.080.073
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 28

Percentage of Participants Achieving HbA1c <7.0%

GroupValue (Percentage of participants)
1.5 mg Dulaglutide75.9
Placebo33.8
Secondary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Body Weight

GroupValue (kilogram (kg))Spread
1.5 mg Dulaglutide-0.760.224
Placebo0.420.217
Secondary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Fasting Serum Glucose (FSG)

GroupValue (milligrams per deciliter (mg/dL))Spread
1.5 mg Dulaglutide-58.472.339
Placebo-43.642.269
Secondary outcomeNumber· 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)

GroupValue (Percentage of participants)
1.5 mg Dulaglutide51.8
Placebo21.1
Secondary outcomeNumber· Week 28

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

GroupValue (Percentage of participants)
1.5 mg Dulaglutide74.8
Placebo33.3
Secondary outcomeNumber· Week 28

Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)

GroupValue (Percentage of participants)
1.5 mg Dulaglutide51.8
Placebo21.1
Secondary outcomeLeast squares mean· Baseline, Week 28

Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile

GroupValue (milligrams per deciliter (mg/dL))Spread
1.5 mg Dulaglutide-64.02.42
Placebo-37.72.36

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1.5 mg DulaglutideParticipants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.0 / 1448 / 144113 / 144
PlaceboParticipants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.1 / 14712 / 14799 / 147

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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