Phase 3 · Dulaglutide

NCT01468181 trial results

A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (percentage of participants), Baseline through 52 Weeks. LY2189265 + SU: 85.5; LY2189265 + BG: 83.6; LY2189265 + a-GI: 70.8; LY2189265 + TZD: 80.3; LY2189265 + Glinides: 73.2.

Participants: 394
Status: completed
Completed: 2013-12
Sponsor: Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01468181), updated at source Jan 29, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01468181 measured first

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)percentage of participants · Baseline through 52 Weeks · number

LY2189265 + SUn=131	LY2189265 + BGn=61	LY2189265 + a-GIn=65	LY2189265 + TZDn=66	LY2189265 + Glinidesn=71
85.5	83.6	70.8	80.3	73.2

Percentage of Participants With Hypoglycemic Episodespercentage of participants · Baseline through 52 Weeks · number

LY2189265 + SUn=131	LY2189265 + BGn=61	LY2189265 + a-GIn=65	LY2189265 + TZDn=66	LY2189265 + Glinidesn=71
33.6	3.3	6.2	6.1	9.9

Side effects by arm

Side effects in NCT01468181

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

Event	LY2189265 + SU	LY2189265 + BG	LY2189265 + a-GI	LY2189265 + TZD	LY2189265 + Glinides
Any serious event	6.9%	4.9%	6.2%	1.5%	4.2%
Nasopharyngitis	23.7%	26.2%	16.9%	24.2%	22.5%
Constipation	15.3%	4.9%	12.3%	4.5%	7%
Diarrhoea	9.9%	14.8%	4.6%	7.6%	9.9%
Nausea	13%	3.3%	6.2%	7.6%	4.2%
Influenza	4.6%	11.5%	0%	0%	4.2%
Lipase increased	8.4%	9.8%	9.2%	4.5%	2.8%
Pharyngitis	5.3%	3.3%	4.6%	9.1%	0%
Back pain	6.1%	3.3%	3.1%	9.1%	1.4%
Bronchitis	7.6%	1.6%	0%	3%	2.8%
Decreased appetite	7.6%	4.9%	4.6%	1.5%	2.8%
Dyspepsia	4.6%	3.3%	1.5%	0%	7%
Contusion	1.5%	6.6%	1.5%	3%	2.8%
Hypertension	3.8%	4.9%	6.2%	3%	4.2%
Vomiting	6.1%	1.6%	4.6%	4.5%	1.4%
Weight increased	0%	0%	0%	6.1%	1.4%
Gastritis	3.1%	4.9%	3.1%	4.5%	2.8%
Gastroenteritis	3.1%	4.9%	0%	0%	0%
Pancreatic enzymes increased	1.5%	4.9%	1.5%	0%	1.4%
Amenorrhoea	0%	4.8%	0%	0%	0%
Gastrooesophageal reflux disease	2.3%	1.6%	4.6%	1.5%	2.8%
Diabetic retinopathy	3.1%	0%	0%	4.5%	0%
Injection site pruritus	1.5%	0%	3.1%	4.5%	4.2%
Hepatic steatosis	1.5%	1.6%	1.5%	4.5%	0%
Dental caries	1.5%	1.6%	0%	1.5%	4.2%
Arthralgia	3.1%	0%	1.5%	1.5%	4.2%

Secondary outcomes

What else it measured

Change From Baseline in Glycosylated Hemoglobin (HbA1c)percentage of HbA1c · Baseline, up to 26 Weeks and up to 52 Weeks · mean

Measure	LY2189265 + SUn=131	LY2189265 + BGn=61	LY2189265 + a-GIn=65	LY2189265 + TZDn=66	LY2189265 + Glinidesn=71
26 Weeks	-1.93(0.09)	-1.58(0.11)	-1.67(0.10)	-1.71(0.13)	-1.80(0.12)
52 Weeks	-1.67(0.09)	-1.57(0.11)	-1.65(0.11)	-1.69(0.13)	-1.65(0.13)

Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%percentage of participants · 26 weeks and 52 weeks · number

Measure	LY2189265 + SUn=131	LY2189265 + BGn=61	LY2189265 + a-GIn=65	LY2189265 + TZDn=66	LY2189265 + Glinidesn=71
HbA1c ≤6.5% at Week 26	35.1	54.1	72.3	60.6	53.5
HbA1c ≤6.5% at Week 52	31.3	57.4	70.8	57.6	47.9
HbA1c <7.0% at Week 26	61.8	73.8	81.5	72.7	69.0
HbA1c <7.0% at Week 52	48.9	73.8	83.1	77.3	62.0

Change From Baseline in Fasting Blood Glucose (FBG)milligrams/deciliters (mg/dL) · Baseline, up to 26 weeks and up to 52 weeks · mean

Measure	LY2189265 + SUn=131	LY2189265 + BGn=61	LY2189265 + a-GIn=65	LY2189265 + TZDn=66	LY2189265 + Glinidesn=71
26 Weeks	-46.8(4.2)	-37.9(4.0)	-46.8(4.7)	-42.1(4.5)	-42.7(3.9)
52 Weeks	-43.2(3.8)	-36.0(4.2)	-47.0(4.7)	-39.6(5.0)	-45.8(4.0)

Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)mg/dL · Baseline, up to 26 weeks and up to 52 weeks · mean

Measure	LY2189265 + SUn=131	LY2189265 + BGn=61	LY2189265 + a-GIn=65	LY2189265 + TZDn=66	LY2189265 + Glinidesn=71
Pre-morning mean at 26 Weeks (n=131,61,64,66,71)	-44.70(4.57)	-34.60(3.88)	-45.97(4.99)	-35.40(3.85)	-48.26(4.33)
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)	-42.93(3.89)	-37.19(3.83)	-45.69(5.05)	-39.83(4.24)	-46.45(4.30)
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)	-69.66(5.69)	-64.23(6.35)	-73.43(6.70)	-65.73(5.94)	-67.99(7.24)
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)	-58.50(5.63)	-63.81(7.22)	-73.62(7.27)	-67.51(6.49)	-73.78(7.95)
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)	-49.95(4.85)	-26.26(4.93)	-54.75(6.24)	-51.80(6.68)	-54.51(5.79)
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)	-43.90(5.15)	-33.34(5.12)	-55.96(6.42)	-50.21(7.04)	-56.07(5.60)
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)	-67.24(5.24)	-50.03(5.70)	-67.70(7.37)	-80.02(7.93)	-68.49(7.84)
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)	-57.27(5.44)	-52.70(5.26)	-63.47(7.12)	-81.64(8.68)	-65.46(7.23)
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)	-44.57(5.63)	-25.66(5.28)	-57.82(6.83)	-43.22(7.53)	-46.85(5.88)
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)	-43.90(5.39)	-25.34(5.55)	-54.66(7.35)	-42.15(7.44)	-51.64(6.10)
2hr postevening meal at 26Weeks(n=128,61,65,66,69)	-62.24(6.05)	-45.41(6.71)	-71.15(7.57)	-66.14(8.22)	-68.75(7.88)
2hr postevening meal at 52Weeks(n=128,61,65,66,69)	-58.98(5.71)	-48.61(6.45)	-63.82(7.00)	-69.30(8.60)	-64.22(7.07)

Change From Baseline in Body Weightkilograms (kg) · Baseline, up to 26 weeks and up to 52 weeks · mean

Measure	LY2189265 + SUn=131	LY2189265 + BGn=61	LY2189265 + a-GIn=65	LY2189265 + TZDn=66	LY2189265 + Glinidesn=71
26 Weeks	0.02(0.22)	-0.74(0.39)	-1.22(0.33)	0.78(0.30)	0.19(0.25)
52 Weeks	0.10(0.24)	-0.87(0.40)	-1.24(0.42)	1.02(0.35)	0.04(0.26)

Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)percentage of HOMA2 · Baseline, up to 26 weeks and up to 52 weeks · mean

Measure	LY2189265 + SUn=127	LY2189265 + BGn=59	LY2189265 + a-GIn=62	LY2189265 + TZDn=59	LY2189265 + Glinidesn=64
HOMA2-%B, 26 Weeks	29.10(2.75)	28.15(2.79)	30.88(3.25)	27.34(2.60)	26.93(2.59)
HOMA2-%B, 52 Weeks	26.06(2.77)	26.05(2.97)	28.06(3.61)	25.38(2.53)	33.51(3.81)
HOMA2-%S, 26 Weeks	-4.80(3.40)	-3.48(4.39)	7.57(5.60)	-5.50(5.21)	-4.41(4.05)
HOMA2-%S, 52 Weeks	-3.99(3.18)	-3.83(4.89)	6.86(5.24)	0.47(5.87)	-5.51(4.71)

The trial

How NCT01468181 was run

This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).

LY2189265 + Sulfonylureas (SU): LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
LY2189265 + Biguanides (BG): LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
LY2189265 + alpha-glucosidase inhibitor (a-GI): LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
LY2189265 + Thiazolidinedione (TZD): LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
LY2189265 + Glinides: LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.

Who could join the trial

Inclusion Criteria: * Participants who have had a diagnosis of type 2 diabetes mellitus before screening * Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening * Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening * Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (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 within the 3 months before screening * Participants who are currently taking insulin or have had previous insulin treatment within the 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)

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

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.