Phase 3 · Dulaglutide

AWARD-CHN1 trial results

The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Monotherapy Compared to Glimepiride in Patients With Type 2 Diabetes Mellitus

Change From Baseline in HbA1c at 26 Weeks (percentage of HbA1c), Baseline, 26 Weeks. 1.5 mg Dulaglutide: -1.48; 0.75 mg Dulaglutide: -1.22; Glimepiride: -0.92.

Participants: 737
Status: completed
Completed: 2014-08
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01644500), updated at source Sep 18, 2019. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What AWARD-CHN1 measured first

Change From Baseline in HbA1c at 26 Weekspercentage of HbA1c · Baseline, 26 Weeks · least squares mean

1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
-1.48(0.069)	-1.22(0.069)	-0.92(0.069)

Side effects by arm

Side effects in AWARD-CHN1

Percent of participants affected. The most common events the registry lists.

Event	1.5 mg Dulaglutide	0.75 mg Dulaglutide	Glimepiride
Any serious event	2.5%	1.6%	1.2%
Diarrhoea	17.2%	7.3%	2.9%
Hyperlipidaemia	11.1%	12.1%	16.9%
Nausea	10.2%	5.2%	0.4%
Vomiting	7.8%	1.6%	0.4%
Abdominal distension	6.6%	2.4%	2.1%
Nasopharyngitis	6.6%	5.2%	5.3%
Lipase increased	6.1%	5.6%	2.5%
Decreased appetite	6.1%	5.2%	0.4%
Upper respiratory tract infection	4.1%	3.2%	4.5%
Dyslipidaemia	3.7%	3.6%	4.1%
Amylase increased	3.7%	2.4%	0.4%
Constipation	3.3%	2.8%	0%
Hypertension	3.3%	1.6%	2.5%
Abdominal pain upper	2.5%	2.4%	0.4%
Urinary tract infection	2%	0%	2.5%
Abdominal discomfort	2%	0.8%	2.1%
Asthenia	0.4%	1.2%	2.1%
Dyspepsia	2%	0.8%	0.4%
Weight decreased	2%	0.8%	0.4%
Headache	2%	1.6%	0.8%
Dysmenorrhoea	0%	1.8%	0%
Chest discomfort	1.6%	0.8%	0.8%
Gastroenteritis	1.6%	0%	0.4%
Lipids increased	0.8%	1.6%	0.8%
Arthralgia	1.2%	0.4%	1.6%

Secondary outcomes

What else it measured

Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weekspercentage of participants · 26 Weeks · number

Measure	1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
HbA1c ≤6.5%	59.4	47.7	41.3
HbA1c <7.0%	74.1	63.6	57.4

Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeksmillimoles per liter (mmol/L) · Baseline, 26 Weeks · least squares mean

1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
-2.71(0.135)	-2.26(0.137)	-1.89(0.136)

Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeksmmol/L · Baseline, 26 Weeks · least squares mean

Measure	1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
Morning (fasting)	-2.47(0.092)	-1.91(0.092)	-1.80(0.091)
Morning (2 hours post-prandial) meal	-4.56(0.180)	-3.75(0.181)	-3.20(0.179)
Midday (pre-prandial) meal	-3.09(0.151)	-2.43(0.151)	-2.37(0.150)
Midday (2 hours post-prandial) meal	-4.15(0.174)	-3.40(0.174)	-2.58(0.173)
Evening (pre-prandial) meal	-2.36(0.135)	-1.77(0.136)	-1.69(0.134)
Evening (2 hours post-prandial) meal	-3.63(0.164)	-2.80(0.165)	-2.35(0.164)
Bedtime	-3.22(0.152)	-2.69(0.152)	-2.03(0.150)

Rate of Hypoglycemic Episodesepisodes/participant/30 days · Baseline through 26 Weeks · mean

Measure	1.5 mg Dulaglutiden=244	0.75 mg Dulaglutiden=247	Glimepiriden=243
All Hypoglycemic Episodes	0.01(0.053)	0.01(0.041)	0.09(0.581)
Severe Hypoglycemic Episodes	NA(NA)	NA(NA)	NA(NA)
Nocturnal Hypoglycemic Episodes	0.00(0.011)	0.00(0.010)	0.01(0.057)

Number of Participants With Self-Reported Hypoglycemic Episodesparticipants · Baseline through 26 Weeks · number

1.5 mg Dulaglutiden=244	0.75 mg Dulaglutiden=248	Glimepiriden=243
14	9	38

Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weekspercentage of HOMA2-%B · Baseline, up to 26 Weeks · least squares mean

Measure	1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
Insulin-based HOMA-2%B	47.40(2.624)	37.92(2.664)	30.00(2.591)
C-peptide HOMA-2%B	41.02(1.945)	34.57(1.974)	24.58(1.964)

Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weekspercentage of HOMA2-%S · Baseline, up to 26 Weeks · least squares mean

Measure	1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
Insulin-Based HOMA2-%S	-6.85(2.636)	-10.33(2.662)	-7.19(2.602)
C-Peptide-Based HOMA2-%S	-6.44(2.056)	-11.84(2.082)	-5.05(2.074)

Change From Baseline in Pancreatic Enzymes at 26 Weeksunits per liter (u/L) · Baseline, 26 Weeks · mean

Measure	1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
Total amylase	9.29(16.237)	7.04(13.128)	3.79(12.538)
Pancreas-derived amylase	6.19(12.824)	4.92(8.123)	2.64(8.218)
Lipase	10.62(30.086)	9.28(22.651)	2.38(22.717)

Change From Baseline in Serum Calcitonin at 26 Weekspicomoles per liter (pmol/L) · Baseline, 26 Weeks · mean

1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
-0.01(0.318)	-0.02(0.298)	0.02(1.193)

Change From Baseline in Sitting Blood Pressure at 26 Weeksmillimeters of mercury (mmHg) · Baseline, 26 Weeks · least squares mean

Measure	1.5 mg Dulaglutiden=222	0.75 mg Dulaglutiden=224	Glimepiriden=231
SBP	-2.07(0.815)	-1.88(0.813)	-0.66(0.804)
DBP	-0.10(0.535)	-0.11(0.534)	0.15(0.526)

Change From Baseline in Sitting Pulse Rate at 26 Weeksbeats per minute (bpm) · Baseline, 26 Weeks · least squares mean

1.5 mg Dulaglutiden=222	0.75 mg Dulaglutiden=224	Glimepiriden=231
3.07(0.581)	1.24(0.581)	-0.34(0.572)

Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeksmilliseconds (msec) · Baseline, 26 Weeks · mean

Measure	1.5 mg Dulaglutiden=239	0.75 mg Dulaglutiden=239	Glimepiriden=242
QT interval	-6.18(21.469)	-2.06(19.549)	1.21(23.021)
PR interval	3.73(13.411)	3.29(11.236)	-0.23(10.184)

The trial

How AWARD-CHN1 was run

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.

1.5 mg Dulaglutide: 1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
0.75 mg Dulaglutide: 0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
Glimepiride: 1 to 3 mg per day (mg/day) glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.

Who could join the trial

Inclusion Criteria: * Type 2 diabetes mellitus * OAM-naïve or have been taking OAM monotherapy for at least 3 months * Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or ≥6.5% to ≤10.0% for participants taking OAM monotherapy * Adult men or adult non-pregnant, non-breastfeeding women * Stable weight (±5%) ≥3 months prior to screening * Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m\^2) Exclusion Criteria: * Have type 1 diabetes mellitus * Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening * Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening * Have gastric emptying abnormality * Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke * Have poorly controlled hypertension (systolic blood pressure above 160 millimeters of mercury \[mmHg\] or diastolic blood pressure above 95 mmHg) * Have impaired liver function * Have impaired kidney function * Have history of chronic pancreatitis or acute pancreatitis * Have a serum calcitonin ≥20 picogram/milliliter (pg/mL) * Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma or multiple endocrine neoplasia type 2 (MEN 2)

Published papers

Papers from AWARD-CHN1

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

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