Phase 3 · Dulaglutide

NCT01558271 trial results

A Phase 3 Study of LY2189265 Monotherapy Compared to Placebo and Liraglutide in Patients With Type 2 Diabetes Mellitus

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks (percentage of HbA1c), Baseline, 26 weeks. LY2189265: -1.43; Placebo: 0.14; Liraglutide: -1.33.

Participants: 492
Status: completed
Completed: 2014-05
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01558271), updated at source May 22, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01558271 measured first

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weekspercentage of HbA1c · Baseline, 26 weeks · least squares mean

LY2189265n=280	Placebon=68	Liraglutiden=136
-1.43(0.05)	0.14(0.10)	-1.33(0.07)

Side effects by arm

Side effects in NCT01558271

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

Event	LY2189265	Placebo/LY2189265	Liraglutide
Any serious event	3.2%	7.1%	5.1%
Nasopharyngitis	18.6%	10%	17.5%
Diarrhoea	7.1%	8.6%	4.4%
Constipation	7.9%	5.7%	8%
Nausea	6.1%	2.9%	8%
Hypoaesthesia	0.7%	7.1%	0.7%
Uterine leiomyoma	1.9%	6.7%	0%
Cystocele	0%	6.7%	0%
Rectocele	0%	6.7%	0%
Decreased appetite	0.7%	2.9%	5.8%
Abdominal distension	4.3%	0%	5.1%
Back pain	2.9%	4.3%	4.4%
Dental caries	1.4%	4.3%	2.9%
Influenza	0.4%	4.3%	1.5%
Pharyngitis	1.1%	4.3%	2.2%
Dizziness	0.4%	4.3%	0.7%
Abdominal discomfort	3.2%	1.4%	3.6%
Injection site pruritus	1.8%	0%	3.6%
Contusion	1.4%	0%	3.6%
Lipase increased	3.6%	2.9%	2.2%
Headache	0.7%	2.9%	3.6%
Abdominal pain	1.1%	2.9%	0.7%
Abdominal pain upper	1.4%	2.9%	2.2%
Gastrooesophageal reflux disease	0.7%	1.4%	2.9%
Large intestine polyp	1.1%	0%	2.9%
Injection site erythema	0.4%	0%	2.9%

Secondary outcomes

What else it measured

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weekspercentage of HbA1c · Baseline, 52 weeks · least squares mean

LY2189265n=280	Placebo/LY2189265n=68	Liraglutiden=136
-1.39(0.06)	-1.55(0.12)	-1.19(0.08)

Percentage of Participants Who Achieved HbA1c <=6.5% or <7%percentage of participants · Up to 26 and 52 weeks · number

Measure	LY2189265n=280	Placebo/LY2189265n=68	Liraglutiden=136
HbA1c <7%, 26 weeks	71.4	5.9	69.1
HbA1c <=6.5%, 26 weeks	50.0	1.5	49.3
HbA1c <7%, 52 weeks	67.9	70.6	60.3
HbA1c <=6.5%, 52 weeks	49.3	52.9	41.2

Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeksmilligrams per deciliter (mg/dL) · Baseline, 26 weeks, 52 weeks · least squares mean

Measure	LY2189265n=276	Placebo/LY2189265n=62	Liraglutiden=134
26 weeks	-39.18(1.60)	1.03(3.30)	-39.75(2.27)
52 weeks	-38.93(1.72)	-40.93(3.62)	-37.15(2.47)

Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeksmilligrams per deciliter (mg/dL) · Baseline, 26 weeks, 52 weeks · least squares mean

Measure	LY2189265n=277	Placebo/LY2189265n=69	Liraglutiden=133
Pre-morning meal, 26 weeks	-39.65(1.55)	-0.15(3.04)	-34.93(2.19)
2 hours post-morning meal, 26 weeks	-69.64(2.80)	-9.29(5.48)	-61.67(3.96)
Pre-midday meal, 26 weeks	-48.47(2.05)	3.91(4.03)	-45.08(2.91)
2 hours post-midday meal, 26 weeks	-67.57(2.94)	-1.50(5.77)	-66.71(4.16)
Pre-evening meal, 26 weeks	-39.64(2.15)	9.25(4.22)	-36.62(3.05)
2 hours post-evening meal	-56.70(2.83)	0.93(5.56)	-53.14(4.01)
Bedtime, 26 weeks	-53.39(2.81)	4.26(5.51)	-51.07(3.94)
Pre-morning meal, 52 weeks	-37.46(1.58)	-30.12(3.10)	-33.41(2.23)
2 hours post-morning meal, 52 weeks	-66.96(2.87)	-65.91(5.62)	-60.69(4.06)
Pre-midday meal, 52 weeks	-47.03(1.86)	-45.15(3.64)	-46.25(2.63)
2 hours post-midday meal, 52 weeks	-68.21(2.74)	-58.52(5.38)	-62.57(3.88)
Pre-evening meal, 52 weeks	-41.04(1.08)	-36.13(3.70)	-32.86(2.67)

Change From Baseline in Body Weight at 26 Weeks and 52 Weekskilograms (kg) · Baseline, 26 weeks, 52 weeks · least squares mean

Measure	LY2189265n=280	Placebo/LY2189265n=70	Liraglutiden=136
26 weeks	-0.02(0.14)	-0.63(0.29)	-0.36(0.20)
52 weeks	-0.17(0.18)	-1.03(0.37)	-0.13(0.26)

Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weekspercentage of HOMA2 · Baseline, 26 weeks, 52 weeks · least squares mean

Measure	LY2189265n=275	Placebo/LY2189265n=62	Liraglutiden=131
HOMA2-%S based on FI, 26 weeks (n=254, 57, 115)	-4.83(2.34)	-2.97(4.83)	-4.82(3.43)
HOMA2-%S based on FCP, 26 weeks (n=275, 62, 131)	-5.48(1.93)	-6.32(3.99)	-2.46(2.75)
HOMA2-%S based on FI, 52 weeks (n=260, 60, 120)	-7.75(2.34)	NA(NA)	-5.26(3.38)
HOMA2-%S based on FCP, 52 weeks (n=275, 62, 131)	-11.72(1.88)	NA(NA)	-10.68(2.68)

Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weekspercentage of HOMA2 · Baseline, 26 weeks, 52 weeks · least squares mean

Measure	LY2189265n=275	Placebo/LY2189265n=62	Liraglutiden=131
HHOMA2-%B based on FI, 26 weeks (n=254, 57, 115)	28.42(1.54)	0.08(3.14)	25.35(2.23)
HOMA2-%B based on FCP, 26 weeks (n=275, 62, 131)	27.77(1.27)	2.94(2.61)	25.86(1.79)
HOMA2-%B based on FI, 52 weeks (n=260, 60, 120)	27.81(1.39)	NA(NA)	25.89(1.99)
HOMA2-%B based on FCP, 52 weeks (n=275, 62, 131)	29.59(1.37)	NA(NA)	28.85(1.93)

Percentage of Participants With Hypoglycemic Episodespercentage of participants · Baseline through 26 weeks and Baseline through 52 weeks · number

Measure	LY2189265n=280	Placebo/LY2189265n=70	Liraglutiden=137
26 weeks	2.1	1.4	1.5
52 weeks	2.9	2.9	2.9

30-Day Rate of Hypoglycemic Episodesevents per participant per 30 days · Baseline through 26 weeks and Baseline through 52 weeks · mean

Measure	LY2189265n=280	Placebo/LY2189265n=70	Liraglutiden=136
26 weeks	0.01(0.04)	0.00(0.02)	0.00(0.02)
52 weeks	0.00(0.02)	0.01(0.09)	0.01(0.04)

Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeksparticipants · Baseline through 26 weeks and Baseline through 52 weeks · number

Measure	LY2189265n=280	Placebo/LY2189265n=70	Liraglutiden=137
26 weeks	0	0	0
52 weeks	0	0	0

Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeksbeats per minute (bpm) · Baseline, 26 weeks, 52 weeks · least squares mean

Measure	LY2189265n=280	Placebo/LY2189265n=70	Liraglutiden=136
26 weeks	3.35(0.45)	1.49(0.90)	4.77(0.64)
52 weeks	3.11(0.42)	4.42(0.86)	5.13(0.60)

Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeksmilliliters of mercury (mmHG) · Baseline, 26 weeks, 52 weeks · least squares mean

Measure	LY2189265n=280	Placebo/LY2189265n=70	Liraglutiden=136
SBP, 26 weeks	0.62(0.62)	0.53(1.25)	-2.10(0.89)
DBP, 26 weeks	1.09(0.39)	0.29(0.78)	0.43(0.56)
SBP, 52 weeks	1.32(0.66)	0.37(1.37)	-1.86(0.95)
DBP, 52 weeks	1.41(0.41)	1.16(0.86)	1.17(0.60)

The trial

How NCT01558271 was run

The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.

LY2189265: Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
Placebo/LY2189265: Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
Liraglutide: Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.

Who could join the trial

Inclusion Criteria: * Participants who have had a diagnosis of type 2 diabetes mellitus before screening. * Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization. * Participants who are OAM naïve with a screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%. * Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared (kg/m\^2) to 35.0 kg/m\^2. Exclusion Criteria: * Participants who have a diagnosis of type 1 diabetes. * Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog. * Participants who have been receiving more than half of the maximum dose of sulfonylureas at screening. * Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD treatment within 3 months before screening. * Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening. * Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC).

Published papers

Papers from NCT01558271

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

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