GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

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

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

394

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 18.5-35•HbA1c 7-11%

Primary endpoints

•Treatment-emergent AEs (any)•Documented hypoglycemia

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01468181

Org study ID13991

Secondary IDH9X-JE-GBDQEli Lilly and Company

Timeline

Milestones

Study first posted2011-11-09estimated

Results first posted2014-12-16estimated

Last update posted2015-01-29estimated

Study start2011-11 (month precision)

Primary completion2013-12actual (month precision)

Study completion2013-12actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

SexAll

Healthy volunteersNot accepted

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)

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, up to 26 weeks and up to 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms (kg)	95% CI
LY2189265 + SU26 Weeks	0.02	—
52 Weeks	0.10	—
LY2189265 + BG26 Weeks	-0.74	—
52 Weeks	-0.87	—
LY2189265 + a-GI26 Weeks	-1.22	—
52 Weeks	-1.24	—
LY2189265 + TZD26 Weeks	0.78	—
52 Weeks	1.02	—
LY2189265 + Glinides26 Weeks	0.19	—
52 Weeks	0.04	—

Mean Difference (Final Values)-0.1495% CI-0.40 – 0.12p<0.277t-test, 2 sided

Body weight at 26 Weeks

Mean Difference (Final Values)-0.1395% CI-0.42 – 0.16p0.382t-test, 2 sided

Body weight at 52 Weeks

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, up to 26 weeks and up to 52 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Secondary/registry result

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, up to 26 Weeks and up to 52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of HbA1c	95% CI
LY2189265 + SU26 Weeks	-1.93	—
52 Weeks	-1.67	—
LY2189265 + BG26 Weeks	-1.58	—
52 Weeks	-1.57	—
LY2189265 + a-GI26 Weeks	-1.67	—
52 Weeks	-1.65	—
LY2189265 + TZD26 Weeks	-1.71	—
52 Weeks	-1.69	—
LY2189265 + Glinides26 Weeks	-1.80	—
52 Weeks	-1.65	—

Mean Difference (Final Values)-1.7795% CI-1.87 – -1.67p<0.001t-test, 2 sided

HbA1c at 26 Weeks

Mean Difference (Final Values)-1.6595% CI-1.75 – -1.55p<0.001t-test, 2 sided

HbA1c at 52 Weeks

Secondary/registry result

Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%

Time frame:26 weeks and 52 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
LY2189265 + SUHbA1c ≤6.5% at Week 26	35.1	—
HbA1c ≤6.5% at Week 52	31.3	—
HbA1c <7.0% at Week 26	61.8	—
HbA1c <7.0% at Week 52	48.9	—
LY2189265 + BGHbA1c ≤6.5% at Week 26	54.1	—
HbA1c ≤6.5% at Week 52	57.4	—
HbA1c <7.0% at Week 26	73.8	—
HbA1c <7.0% at Week 52	73.8	—
LY2189265 + a-GIHbA1c ≤6.5% at Week 26	72.3	—
HbA1c ≤6.5% at Week 52	70.8	—
HbA1c <7.0% at Week 26	81.5	—
HbA1c <7.0% at Week 52	83.1	—
LY2189265 + TZDHbA1c ≤6.5% at Week 26	60.6	—
HbA1c ≤6.5% at Week 52	57.6	—
HbA1c <7.0% at Week 26	72.7	—
HbA1c <7.0% at Week 52	77.3	—
LY2189265 + GlinidesHbA1c ≤6.5% at Week 26	53.5	—
HbA1c ≤6.5% at Week 52	47.9	—
HbA1c <7.0% at Week 26	69.0	—
HbA1c <7.0% at Week 52	62.0	—

Secondary/registry result

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, up to 26 weeks and up to 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), milligrams/deciliters (mg/dL)	95% CI
LY2189265 + SU26 Weeks	-46.8	—
52 Weeks	-43.2	—
LY2189265 + BG26 Weeks	-37.9	—
52 Weeks	-36.0	—
LY2189265 + a-GI26 Weeks	-46.8	—
52 Weeks	-47.0	—
LY2189265 + TZD26 Weeks	-42.1	—
52 Weeks	-39.6	—
LY2189265 + Glinides26 Weeks	-42.7	—
52 Weeks	-45.8	—

Median Difference (Final Values)-43.995% CI-47.8 – -40.0p<0.001t-test, 2 sided

FBG at 26 Weeks

Mean Difference (Final Values)-42.695% CI-46.4 – -38.7p<0.001t-test, 2 sided

FBG at 52 Weeks

Secondary/registry result

Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)

Time frame:Baseline, up to 26 weeks and up to 52 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
LY2189265 + SUPre-morning mean at 26 Weeks (n=131,61,64,66,71)	-44.70	—
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)	-42.93	—
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)	-69.66	—
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)	-58.50	—
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)	-49.95	—
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)	-43.90	—
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)	-67.24	—
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)	-57.27	—
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)	-44.57	—
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)	-43.90	—
2hr postevening meal at 26Weeks(n=128,61,65,66,69)	-62.24	—
2hr postevening meal at 52Weeks(n=128,61,65,66,69)	-58.98	—
Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)	-61.07	—
Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)	-54.07	—
LY2189265 + BGPre-morning mean at 26 Weeks (n=131,61,64,66,71)	-34.60	—
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)	-37.19	—
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)	-64.23	—
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)	-63.81	—
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)	-26.26	—
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)	-33.34	—
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)	-50.03	—
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)	-52.70	—
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)	-25.66	—
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)	-25.34	—
2hr postevening meal at 26Weeks(n=128,61,65,66,69)	-45.41	—
2hr postevening meal at 52Weeks(n=128,61,65,66,69)	-48.61	—
Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)	-49.98	—
Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)	-52.70	—
LY2189265 + a-GIPre-morning mean at 26 Weeks (n=131,61,64,66,71)	-45.97	—
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)	-45.69	—
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)	-73.43	—
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)	-73.62	—
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)	-54.75	—
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)	-55.96	—
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)	-67.70	—
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)	-63.47	—
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)	-57.82	—
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)	-54.66	—
2hr postevening meal at 26Weeks(n=128,61,65,66,69)	-71.15	—
2hr postevening meal at 52Weeks(n=128,61,65,66,69)	-63.82	—
Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)	-63.98	—
Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)	-66.74	—
LY2189265 + TZDPre-morning mean at 26 Weeks (n=131,61,64,66,71)	-35.40	—
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)	-39.83	—
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)	-65.73	—
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)	-67.51	—
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)	-51.80	—
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)	-50.21	—
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)	-80.02	—
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)	-81.64	—
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)	-43.22	—
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)	-42.15	—
2hr postevening meal at 26Weeks(n=128,61,65,66,69)	-66.14	—
2hr postevening meal at 52Weeks(n=128,61,65,66,69)	-69.30	—
Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)	-66.19	—
Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)	-68.42	—
LY2189265 + GlinidesPre-morning mean at 26 Weeks (n=131,61,64,66,71)	-48.26	—
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)	-46.45	—
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)	-67.99	—
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)	-73.78	—
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)	-54.51	—
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)	-56.07	—
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)	-68.49	—
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)	-65.46	—
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)	-46.85	—
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)	-51.64	—
2hr postevening meal at 26Weeks(n=128,61,65,66,69)	-68.75	—
2hr postevening meal at 52Weeks(n=128,61,65,66,69)	-64.22	—
Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)	-64.01	—
Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)	-64.41	—

Mean Difference (Final Values)-42.4295% CI-46.55 – -38.29p<0.001t-test, 2 sided

Pre-morning meal at 26 Weeks

Mean Difference (Final Values)-42.6095% CI-46.44 – -38.76p<0.001t-test, 2 sided

Pre-morning meal at 52 Weeks

Mean Difference (Final Values)-68.4895% CI-74.18 – -62.79p<0.001t-test, 2 sided

2 hours post-morning meal at 26 Weeks

Mean Difference (Final Values)-66.0895% CI-72.12 – -60.04p<0.001t-test, 2 sided

2 hours post-morning meal at 52 Weeks

Mean Difference (Final Values)-48.2195% CI-53.32 – -43.09p<0.001t-test, 2 sided

Pre-midday meal at 26 Weeks

Mean Difference (Final Values)-47.5195% CI-52.77 – -42.24p<0.001t-test, 2 sided

Pre-midday meal at 52 Weeks

Mean Difference (Final Values)-67.0695% CI-73.02 – -61.11p<0.001t-test, 2 sided

2 hours post-midday meal at 26 Weeks

Mean Difference (Final Values)-63.1795% CI-69.16 – -57.18p<0.001t-test, 2 sided

2 hours post-midday meal at 52 Weeks

Mean Difference (Final Values)-44.0095% CI-49.67 – -38.34p<0.001t-test, 2 sided

Pre-evening meal at 26 Weeks

Mean Difference (Final Values)-43.8895% CI-49.55 – -38.21p<0.001t-test, 2 sided

Pre-evening meal at 52 Weeks

Mean Difference (Final Values)-62.9195% CI-69.32 – -56.50p<0.001t-test, 2 sided

2 hours post-evening meal at 26 Weeks

Mean Difference (Final Values)-60.8495% CI-66.95 – -54.74p<0.001t-test, 2 sided

2 hours post-evening meal at 52 Weeks

Mean Difference (Final Values)-61.1595% CI-66.93 – -55.37p<0.001t-test, 2 sided

Bedtime meal at 26 Weeks

Mean Difference (Final Values)-60.1695% CI-66.07 – -54.25p<0.001t-test, 2 sided

Bedtime meal at 52 Weeks

Secondary/registry result

Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)

Time frame:Baseline, up to 26 weeks and up to 52 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), percentage of HOMA2	95% CI
LY2189265 + SUHOMA2-%B, 26 Weeks	29.10	—
HOMA2-%B, 52 Weeks	26.06	—
HOMA2-%S, 26 Weeks	-4.80	—
HOMA2-%S, 52 Weeks	-3.99	—
LY2189265 + BGHOMA2-%B, 26 Weeks	28.15	—
HOMA2-%B, 52 Weeks	26.05	—
HOMA2-%S, 26 Weeks	-3.48	—
HOMA2-%S, 52 Weeks	-3.83	—
LY2189265 + a-GIHOMA2-%B, 26 Weeks	30.88	—
HOMA2-%B, 52 Weeks	28.06	—
HOMA2-%S, 26 Weeks	7.57	—
HOMA2-%S, 52 Weeks	6.86	—
LY2189265 + TZDHOMA2-%B, 26 Weeks	27.34	—
HOMA2-%B, 52 Weeks	25.38	—
HOMA2-%S, 26 Weeks	-5.50	—
HOMA2-%S, 52 Weeks	0.47	—
LY2189265 + GlinidesHOMA2-%B, 26 Weeks	26.93	—
HOMA2-%B, 52 Weeks	33.51	—
HOMA2-%S, 26 Weeks	-4.41	—
HOMA2-%S, 52 Weeks	-5.51	—

Mean Difference (Final Values)28.5995% CI26.00 – 31.18p<0.001t-test, 2 sided

HOMA2-B% at 26 Weeks

Mean Difference (Final Values)27.5795% CI24.73 – 30.41p<0.001t-test, 2 sided

HOMA2-B% at 52 Weeks

Mean Difference (Final Values)-2.5795% CI-6.46 – 1.32p0.194t-test, 2 sided

HOMA2-S% at 26 Weeks

Mean Difference (Final Values)-1.7065% CI-5.68 – 2.27p0.400t-test, 2 sided

HOMA2-S% at 52 Weeks

Secondary/protocol endpoint

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, up to 26 Weeks and up to 52 Weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%

Time frame:26 weeks and 52 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame:Baseline, up to 26 weeks and up to 52 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)

Time frame:Baseline, up to 26 weeks and up to 52 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)

Time frame:Baseline, up to 26 weeks and up to 52 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Primary/registry result

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:Baseline through 52 Weeks

Treatment-emergent AEs (any)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
LY2189265 + SU	85.5	—
LY2189265 + BG	83.6	—
LY2189265 + a-GI	70.8	—
LY2189265 + TZD	80.3	—
LY2189265 + Glinides	73.2	—

Primary/registry result

Percentage of Participants With Hypoglycemic Episodes

Time frame:Baseline through 52 Weeks

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
LY2189265 + SU	33.6	—
LY2189265 + BG	3.3	—
LY2189265 + a-GI	6.2	—
LY2189265 + TZD	6.1	—
LY2189265 + Glinides	9.9	—

Primary/protocol endpoint

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame:Baseline through 52 Weeks

Treatment-emergent AEs (any)

threshold achievement, event

Primary/protocol endpoint

Percentage of Participants With Hypoglycemic Episodes

Time frame:Baseline through 52 Weeks

Documented hypoglycemia

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.