Phase 3 · Dulaglutide

AWARD-CHN3 trial results

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

Change From Baseline in Hemoglobin A1c (HbA1c) (Percentage of HbA1c), Baseline, Week 28. 1.5 mg Dulaglutide: -2.03; Placebo: -1.08.

Participants
291
Status
completed
Completed
2022-04-28
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT04591626), updated at source May 24, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What AWARD-CHN3 measured first

Change From Baseline in Hemoglobin A1c (HbA1c)Percentage of HbA1c · Baseline, Week 28 · least squares mean
1.5 mg Dulaglutiden=133Placebon=142
-2.03(0.076)-1.08(0.073)
Side effects by arm

Side effects in AWARD-CHN3

Percent of participants affected, Baseline Through End of Safety Follow-Up (Up To 32 Weeks). The most common events the registry lists.

Event1.5 mg DulaglutidePlacebo
Any serious event5.6%8.2%
Decreased appetite22.2%4.1%
Diabetic nephropathy13.9%15%
Diarrhoea13.2%8.2%
Nausea10.4%5.4%
Vomiting9%1.4%
Abdominal distension7.6%1.4%
Upper respiratory tract infection7.6%6.8%
Hyperglycaemia2.8%7.5%
Hyperlipidaemia6.3%4.8%
Dyspepsia5.6%0.7%
Toothache3.5%5.4%
Cervical cyst0%5.3%
Constipation4.9%2.7%
Asthenia4.9%0.7%
Hypertension3.5%4.8%
Weight decreased4.2%1.4%
Dizziness3.5%4.1%
Abdominal discomfort3.5%0.7%
Gastric dilatation3.5%0%
Vaginal infection0%3.5%
Albumin urine present2.8%1.4%
Headache2.8%1.4%
Cough2.8%2%
Hiccups2.8%0.7%
Pulmonary mass2.8%2.7%
Secondary outcomes

What else it measured

Percentage of Participants Achieving HbA1c <7.0%Percentage of participants · Week 28 · number
1.5 mg Dulaglutiden=133Placebon=142
75.933.8
Change From Baseline in Body Weightkilogram (kg) · Baseline, Week 28 · least squares mean
1.5 mg Dulaglutiden=133Placebon=142
-0.76(0.224)0.42(0.217)
Change From Baseline in Fasting Serum Glucose (FSG)milligrams per deciliter (mg/dL) · Baseline, Week 28 · least squares mean
1.5 mg Dulaglutiden=133Placebon=142
-58.47(2.339)-43.64(2.269)
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 · Week 28 · number
1.5 mg Dulaglutiden=139Placebon=147
51.821.1
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)Percentage of participants · Week 28 · number
1.5 mg Dulaglutiden=139Placebon=147
74.833.3
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)Percentage of participants · Week 28 · number
1.5 mg Dulaglutiden=139Placebon=147
51.821.1
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profilemilligrams per deciliter (mg/dL) · Baseline, Week 28 · least squares mean
1.5 mg Dulaglutiden=125Placebon=132
-64.0(2.42)-37.7(2.36)
Change From Baseline in Daily Mean Insulin Glargine DosesInternational Units per day(IU/day) · Baseline, Week 28 · least squares mean
1.5 mg Dulaglutiden=133Placebon=143
10.0(1.045)14.0(1.015)
The trial

How AWARD-CHN3 was run

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.

  • 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: Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Who could join the trial

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) *...

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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