GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes

The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients With Type 2 Diabetes Mellitus

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

755

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7-9.5%

Primary endpoint

•Systolic BP, change

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 IDNCT01149421

Org study ID13631

Secondary IDCTRI/2010/091/001444Clinical Trials Register India

Secondary IDH9X-MC-GBDNEli Lilly and Company

Timeline

Milestones

Study first posted2010-06-23estimated

Last update posted2015-02-02estimated

Results first posted2015-02-02estimated

Study start2010-06 (month precision)

Primary completion2011-09actual (month precision)

Study completion2012-01actual (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening

•Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening

•Mean blood pressure >90/60 millimeters of mercury (mmHg) and <140/90 mmHg at screening

•If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening

•Stable weight for 3 months prior to screening

•Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m^2)

•Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions

•Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control

•Male participants must use a reliable method of birth control

Exclusion criteria

•Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening

•Ongoing or history of frequent intermittent tachyarrhythmia

•Resting heart rate <60 beats per minute (bpm) or >100 bpm at screening

•Work rotating shifts or work during the hours of 2200 to 0700

•Chronic insulin therapy

•Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening

•Nondominant arm circumference >42 centimeter (cm)

•Use of drugs to promote weight loss

•Chronic use of systemic steroids

•Gastric emptying abnormality or bariatric surgery

•Hepatitis, other liver disease, or alanine transaminase (ALT) >3 times the upper limit of normal

•Acute or chronic pancreatitis

•Severe renal impairment

•Active autoimmune disease or uncontrolled endocrine abnormality

•Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia

•Calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening

•Transplanted organ except corneal transplants

•Active or untreated cancer or in remission <5 years, except skin, in situ cervical, or prostate cancer

•Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing

Endpoints (50)

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

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Cardiovascular outcomes

Weight & body composition

Cardiovascular outcomes

2 endpoints

Secondary/registry result

Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks

Time frame:Baseline through 26 weeks

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Non-fatal MI, Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Posted result

Group	Value (number), participants	95% CI
1.5 Milligram (mg) LY2189265Any cardiovascular event	1	—
Any fatal cardiovascular event	0	—
Any non-fatal cardiovascular event	1	—
0.75 Milligram (mg) LY2189265Any cardiovascular event	1	—
Any fatal cardiovascular event	0	—
Any non-fatal cardiovascular event	1	—
PlaceboAny cardiovascular event	4	—
Any fatal cardiovascular event	0	—
Any non-fatal cardiovascular event	4	—

Secondary/protocol endpoint

Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks

Time frame:Baseline through 26 weeks

Expanded / custom MACE composite

composite event, event

componentsAll-cause death, Myocardial infarction (any), Unstable angina hospitalization, Heart-failure hospitalization, Coronary revascularization, Stroke (any)

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Body Weight

Time frame:Baseline, 16 and 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kilogram (kg)	95% CI
1.5 Milligram (mg) LY2189265Week 16	-1.84	—
Week 26	-1.85	—
0.75 Milligram (mg) LY2189265Week 16	-0.83	—
Week 26	-0.86	—
PlaceboWeek 16	-0.13	—
Week 26	-0.08	—

p<0.001Mixed Models Analysis

p0.005Mixed Models Analysis

p<0.001Mixed Models Analysis

p0.012Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Body Weight

Time frame:Baseline, 16 and 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 16 and 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
1.5 Milligram (mg) LY2189265Week 16	-1.18	—
Week 26	-1.01	—
0.75 Milligram (mg) LY2189265Week 16	-1.04	—
Week 26	-0.89	—
PlaceboWeek 16	-0.06	—
Week 26	-0.02	—

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)

Time frame:Baseline, 16 and 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), millimoles per liter (mmol/L)	95% CI
1.5 Milligram (mg) LY2189265Week 16	-2.05	—
Week 26	-1.67	—
0.75 Milligram (mg) LY2189265Week 16	-1.94	—
Week 26	-1.66	—
PlaceboWeek 16	-0.30	—
Week 26	0.00	—

Secondary/registry result

Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%

Time frame:Baseline and 16 and 26 weeks

threshold achievement, improvement

componentsHbA1c <7.0% achievement, HbA1c <6.5% achievement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
1.5 Milligram (mg) LY2189265HbA1c levels <7.0%, Baseline	6.8	—
HbA1c levels ≤6.5%, Baseline	0.0	—
HbA1c levels <7.0%, Week 16 (n=216, n=234, n=225)	66.7	—
HbA1c levels ≤6.5%, Week 16 (n=216, n=234, n=225)	45.8	—
HbA1c levels <7.0%, Week 26 (n=206, n=226, n=210)	62.1	—
HbA1c levels ≤6.5%, Week 26 (n=206, n=226, n=210)	38.8	—
0.75 Milligram (mg) LY2189265HbA1c levels <7.0%, Baseline	6.7	—
HbA1c levels ≤6.5%, Baseline	0.4	—
HbA1c levels <7.0%, Week 16 (n=216, n=234, n=225)	59.0	—
HbA1c levels ≤6.5%, Week 16 (n=216, n=234, n=225)	36.8	—
HbA1c levels <7.0%, Week 26 (n=206, n=226, n=210)	54.9	—
HbA1c levels ≤6.5%, Week 26 (n=206, n=226, n=210)	35.8	—
PlaceboHbA1c levels <7.0%, Baseline	8.0	—
HbA1c levels ≤6.5%, Baseline	0.4	—
HbA1c levels <7.0%, Week 16 (n=216, n=234, n=225)	12.9	—
HbA1c levels ≤6.5%, Week 16 (n=216, n=234, n=225)	6.2	—
HbA1c levels <7.0%, Week 26 (n=206, n=226, n=210)	14.3	—
HbA1c levels ≤6.5%, Week 26 (n=206, n=226, n=210)	5.2	—

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)

Time frame:Baseline, 16 and 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)

Time frame:Baseline, 16 and 26 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%

Time frame:Baseline and 16 and 26 weeks

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

24 endpoints

Primary/registry result

Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

Time frame:Baseline, 16 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265	-3.41	—
0.75 Milligram (mg) LY2189265	-1.70	—
Placebo	-0.63	—

Least Squares Mean Difference-2.7997.3% CI-4.58 – -1.00p<0.001Mixed Models Analysis

Least Squares Mean Difference-1.0797.3% CI-2.83 – 0.68p<0.001Mixed Models Analysis

p<0.001Mixed Models Analysis

p0.149Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

Time frame:Baseline, 16 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/registry result

Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

Time frame:Baseline, 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265	-2.51	—
0.75 Milligram (mg) LY2189265	-1.56	—
Placebo	0.15	—

Least Squares Mean Difference-2.6697.3% CI-4.53 – -0.79p<0.001Mixed Models Analysis

Least Squares Mean Difference-1.7197.3% CI-3.54 – 0.12p<0.001Mixed Models Analysis

p0.002Mixed Models Analysis

p0.36Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)

Time frame:Baseline, 16 and 26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)]	95% CI
1.5 Milligram (mg) LY2189265Mean 24-Hour, Week 16	-0.23	—
Mean 24-Hour, Week 26	0.26	—
0.75 Milligram (mg) LY2189265Mean 24-Hour, Week 16	-0.13	—
Mean 24-Hour, Week 26	-0.09	—
PlaceboMean 24-Hour, Week 16	-0.55	—
Mean 24-Hour, Week 26	-0.24	—

Least Squares Mean Difference0.3297.3% CI-0.80 – 1.43p<0.001Mixed Models Analysis

Least Squares Mean Difference0.4297.3% CI-0.67 – 1.52p<0.001Mixed Models Analysis

p0.870Mixed Models Analysis

p0.915Mixed Models Analysis

Least Squares Mean Difference0.5097.3% CI-0.68 – 1.68p<0.001Mixed Models Analysis

Least Squares Mean Difference0.1697.3% CI-1.00 – 1.31p<0.001Mixed Models Analysis

p0.929Mixed Models Analysis

p0.776Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)

Time frame:Baseline, 16 and 26 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 Milligram (mg) LY2189265Mean 24-Hour HR, Week 16	3.70	—
Mean 24-Hour HR, Week 26	4.18	—
0.75 Milligram (mg) LY2189265Mean 24-Hour HR, Week 16	2.48	—
Mean 24-Hour HR, Week 26	1.94	—
PlaceboMean 24-Hour HR, Week 16	0.86	—
Mean 24-Hour HR, Week 26	0.68	—

Least Squares Mean Difference2.8497.3% CI1.52 – 4.16p0.556Mixed Models Analysis

Least Squares Mean Difference1.6297.3% CI0.32 – 2.92p0.018Mixed Models Analysis

p1.00Mixed Models Analysis

Least Squares Mean Difference3.5097.3% CI2.10 – 4.91p0.904Mixed Models Analysis

Least Squares Mean Difference1.2697.3% CI-0.13 – 2.64p0.005Mixed Models Analysis

p0.996Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure

Time frame:Baseline, 16 and 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265Mean 24-Hour PP, Week 16	-3.07	—
Mean 24-Hour PP, Week 26	-2.64	—
0.75 Milligram (mg) LY2189265Mean 24-Hour PP, Week 16	-1.60	—
Mean 24-Hour PP, Week 26	-1.53	—
PlaceboMean 24-Hour PP, Week 16	-0.02	—
Mean 24-Hour PP, Week 26	0.46	—

Mean Difference (Final Values)-3.0595% CI-4.00 – -2.09p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.5895% CI-2.51 – -0.64p0.001Mixed Models Analysis

Mean Difference (Final Values)-3.1095% CI-4.10 – -2.09p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.9995% CI-2.98 – -1.00p<0.001Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)

Time frame:Baseline, 16 and 26 weeks

Mean arterial pressure

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265Week 16	-1.31	—
Week 26	-0.74	—
0.75 Milligram (mg) LY2189265Week 16	-0.65	—
Week 26	-0.57	—
PlaceboWeek 16	-0.60	—
Week 26	-0.15	—

Mean Difference (Final Values)-0.7195% CI-1.84 – 0.42p0.218Mixed Models Analysis

Mean Difference (Final Values)-0.0595% CI-1.16 – 1.06p0.931Mixed Models Analysis

Mean Difference (Final Values)-0.5895% CI-1.72 – 0.55p0.315Mixed Models Analysis

Mean Difference (Final Values)-0.4295% CI-1.54 – 0.70p0.465Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)

Time frame:Baseline, 16 and 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265Mean Daytime SBP, Week 16 (n=247, n=251, n=249)	-3.67	—
Mean Daytime SBP, Week 26 (n=247, n=251, n=249)	-2.52	—
Mean Nighttime SBP, Week 16 (n=247, n=251, n=249)	-2.32	—
Mean Nighttime SBP, Week 26 (n=247, n=251, n=249)	-2.40	—
Mean Clinic SBP, Week 16 (n=251, n=254, n=250)	-2.33	—
Mean Clinic SBP, Week 26 (n=251, n=254, n=250)	-2.29	—
0.75 Milligram (mg) LY2189265Mean Daytime SBP, Week 16 (n=247, n=251, n=249)	-1.57	—
Mean Daytime SBP, Week 26 (n=247, n=251, n=249)	-1.47	—
Mean Nighttime SBP, Week 16 (n=247, n=251, n=249)	-1.23	—
Mean Nighttime SBP, Week 26 (n=247, n=251, n=249)	-1.43	—
Mean Clinic SBP, Week 16 (n=251, n=254, n=250)	-1.26	—
Mean Clinic SBP, Week 26 (n=251, n=254, n=250)	-0.74	—
PlaceboMean Daytime SBP, Week 16 (n=247, n=251, n=249)	-0.34	—
Mean Daytime SBP, Week 26 (n=247, n=251, n=249)	0.35	—
Mean Nighttime SBP, Week 16 (n=247, n=251, n=249)	-1.08	—
Mean Nighttime SBP, Week 26 (n=247, n=251, n=249)	-0.05	—
Mean Clinic SBP, Week 16 (n=251, n=254, n=250)	-0.73	—
Mean Clinic SBP, Week 26 (n=251, n=254, n=250)	0.40	—

Mean Difference (Final Values)-3.3395% CI-5.04 – -1.61p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.2395% CI-2.91 – 0.46p0.153Mixed Models Analysis

Mean Difference (Final Values)-2.8795% CI-4.66 – -1.09p0.002Mixed Models Analysis

Mean Difference (Final Values)-1.8295% CI-3.57 – -0.07p0.042Mixed Models Analysis

Mean Difference (Final Values)-1.2495% CI-3.23 – 0.75p0.221Mixed Models Analysis

Mean Difference (Final Values)-0.1595% CI-2.10 – 1.81p0.884Mixed Models Analysis

Mean Difference (Final Values)-2.3595% CI-4.31 – -0.39p0.19Mixed Models Analysis

Mean Difference (Final Values)-1.3895% CI-3.31 – 0.54p0.159Mixed Models Analysis

p0.122Mixed Models Analysis

p0.601Mixed Models Analysis

p0.012Mixed Models Analysis

p0.274Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)

Time frame:Baseline, 16 and 26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265Mean Daytime DBP, Week 16 (n=247, n=251, n=249)	-0.09	—
Mean Daytime DBP, Week 26 (n=247, n=251, n=249)	0.52	—
Mean Nighttime DBP, Week 16 (n=247, n=251, n=249)	-0.01	—
Mean Nighttime DBP, Week 26 (n=247, n=251, n=249)	-0.22	—
Mean Clinic DBP, Week 16 (n=251, n=254, n=250)	-0.21	—
Mean Clinic DBP, Week 26 (n=251, n=254, n=250)	0.59	—
0.75 Milligram (mg) LY2189265Mean Daytime DBP, Week 16 (n=247, n=251, n=249)	0.14	—
Mean Daytime DBP, Week 26 (n=247, n=251, n=249)	0.08	—
Mean Nighttime DBP, Week 16 (n=247, n=251, n=249)	-0.28	—
Mean Nighttime DBP, Week 26 (n=247, n=251, n=249)	-0.42	—
Mean Clinic DBP, Week 16 (n=251, n=254, n=250)	0.76	—
Mean Clinic DBP, Week 26 (n=251, n=254, n=250)	0.69	—
PlaceboMean Daytime DBP, Week 16 (n=247, n=251, n=249)	-0.30	—
Mean Daytime DBP, Week 26 (n=247, n=251, n=249)	-0.07	—
Mean Nighttime DBP, Week 16 (n=247, n=251, n=249)	-1.10	—
Mean Nighttime DBP, Week 26 (n=247, n=251, n=249)	-0.69	—
Mean Clinic DBP, Week 16 (n=251, n=254, n=250)	-0.21	—
Mean Clinic DBP, Week 26 (n=251, n=254, n=250)	0.61	—

Mean Difference (Final Values)0.2195% CI-0.91 – 1.32p0.717Mixed Models Analysis

Mean Difference (Final Values)0.4495% CI-0.65 – 1.54p0.427Mixed Models Analysis

Mean Difference (Final Values)0.6095% CI-0.53 – 1.73p0.300Mixed Models Analysis

Mean Difference (Final Values)0.1595% CI-0.96 – 1.26p0.788Mixed Models Analysis

Mean Difference (Final Values)1.0895% CI-0.20 – 2.37p0.098Mixed Models Analysis

Mean Difference (Final Values)0.8295% CI-0.44 – 2.08p0.203Mixed Models Analysis

Mean Difference (Final Values)0.4795% CI-0.88 – 1.82p0.493Mixed Models Analysis

Mean Difference (Final Values)0.2795% CI-1.06 – 1.60p0.692Mixed Models Analysis

p0.990Mixed Models Analysis

p0.173Mixed Models Analysis

p0.972Mixed Models Analysis

p0.904Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)

Time frame:Baseline, 16 and 26 weeks

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats per minute (bpm)	95% CI
1.5 Milligram (mg) LY2189265Mean Daytime HR, Week 16 (n=247, n=251, n=249)	3.56	—
Mean Daytime HR, Week 26 (n=247, n=251, n=249)	4.24	—
Mean Nighttime HR, Week 16 (n=247, n=251, n=249)	4.60	—
Mean Nighttime HR, Week 26 (n=247, n=251, n=249)	4.76	—
Mean Clinic HR, Week 16 (n=251, n=254, n=250)	3.97	—
Mean Clinic HR, Week 26 (n=251, n=254, n=250)	4.89	—
0.75 Milligram (mg) LY2189265Mean Daytime HR, Week 16 (n=247, n=251, n=249)	2.22	—
Mean Daytime HR, Week 26 (n=247, n=251, n=249)	1.59	—
Mean Nighttime HR, Week 16 (n=247, n=251, n=249)	3.43	—
Mean Nighttime HR, Week 26 (n=247, n=251, n=249)	3.01	—
Mean Clinic HR, Week 16 (n=251, n=254, n=250)	2.11	—
Mean Clinic HR, Week 26 (n=251, n=254, n=250)	1.93	—
PlaceboMean Daytime HR, Week 16 (n=247, n=251, n=249)	1.07	—
Mean Daytime HR, Week 26 (n=247, n=251, n=249)	0.67	—
Mean Nighttime HR, Week 16 (n=247, n=251, n=249)	0.65	—
Mean Nighttime HR, Week 26 (n=247, n=251, n=249)	0.77	—
Mean Clinic HR, Week 16 (n=251, n=254, n=250)	0.46	—
Mean Clinic HR, Week 26 (n=251, n=254, n=250)	-0.11	—

Mean Difference (Final Values)2.4995% CI1.17 – 3.80p<0.001Mixed Models Analysis

Mean Difference (Final Values)1.1595% CI-0.14 – 2.45p0.080Mixed Models Analysis

Mean Difference (Final Values)3.5795% CI2.23 – 4.91p<0.001Mixed Models Analysis

Mean Difference (Final Values)0.9295% CI-0.39 – 2.24p0.168Mixed Models Analysis

Mean Difference (Final Values)3.9595% CI2.62 – 5.28p<0.001Mixed Models Analysis

Mean Difference (Final Values)2.7895% CI1.47 – 4.09p<0.001Mixed Models Analysis

Mean Difference (Final Values)3.9895% CI2.49 – 5.47p<0.001Mixed Models Analysis

Mean Difference (Final Values)2.2495% CI0.78 – 3.70p0.003Mixed Models Analysis

p<0.001Mixed Models Analysis

p0.014Mixed Models Analysis

p<0.001Mixed Models Analysis

p0.005Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure

Time frame:Baseline, 16 and 26 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265Mean Daytime PP, Week 16	-3.46	—
Mean Daytime PP, Week 26	-2.90	—
Mean Nighttime PP, Week 16	-2.23	—
Mean Nighttime PP, Week 26	-2.09	—
0.75 Milligram (mg) LY2189265Mean Daytime PP, Week 16	-1.76	—
Mean Daytime PP, Week 26	-1.62	—
Mean Nighttime PP, Week 16	-0.92	—
Mean Nighttime PP, Week 26	-0.96	—
PlaceboMean Daytime PP, Week 16	0.01	—
Mean Daytime PP, Week 26	0.51	—
Mean Nighttime PP, Week 16	0.02	—
Mean Nighttime PP, Week 26	0.65	—

Mean Difference (Final Values)-3.4795% CI-4.50 – -2.43p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.7795% CI-2.79 – -0.75p<0.001Mixed Models Analysis

Mean Difference (Final Values)-3.4095% CI-4.52 – -2.28p<0.001Mixed Models Analysis

Mean Difference (Final Values)-2.1395% CI-3.23 – -1.03p<0.001Mixed Models Analysis

Mean Difference (Final Values)-2.2595% CI-3.43 – -1.07p<0.001Mixed Models Analysis

Mean Difference (Final Values)-0.9395% CI-2.09 – 0.22p0.113Mixed Models Analysis

Mean Difference (Final Values)-2.7495% CI-3.86 – -1.62p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.6195% CI-2.72 – -0.51p0.004Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)

Time frame:Baseline, 16 and 26 weeks

Mean arterial pressure

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), millimeters of mercury (mmHg)	95% CI
1.5 Milligram (mg) LY2189265Mean Daytime MAP, Week 16	-1.30	—
Mean Daytime MAP, Week 26	-0.51	—
Mean Nighttime MAP, Week 16	-0.80	—
Mean Nighttime MAP, Week 26	-0.96	—
0.75 Milligram (mg) LY2189265Mean Daytime MAP, Week 16	-0.42	—
Mean Daytime MAP, Week 26	-0.42	—
Mean Nighttime MAP, Week 16	-0.59	—
Mean Nighttime MAP, Week 26	-0.76	—
PlaceboMean Daytime MAP, Week 16	-0.33	—
Mean Daytime MAP, Week 26	0.05	—
Mean Nighttime MAP, Week 16	-1.11	—
Mean Nighttime MAP, Week 26	-0.50	—

Mean Difference (Final Values)-0.9795% CI-2.22 – 0.28p0.128Mixed Models Analysis

Mean Difference (Final Values)-0.0995% CI-1.32 – 1.13p0.883Mixed Models Analysis

Mean Difference (Final Values)-0.5695% CI-1.84 – 0.72p0.390Mixed Models Analysis

Mean Difference (Final Values)-0.4795% CI-1.72 – 0.79p0.463Mixed Models Analysis

Mean Difference (Final Values)0.3195% CI-1.13 – 1.76p0.671Mixed Models Analysis

Mean Difference (Final Values)0.5295% CI-0.90 – 1.95p0.471Mixed Models Analysis

Mean Difference (Final Values)-0.4695% CI-1.95 – 1.03p0.543Mixed Models Analysis

Mean Difference (Final Values)-0.2695% CI-1.72 – 1.20p0.728Mixed Models Analysis

Secondary/registry result

Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)

Time frame:Baseline, 16 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), milligram per liter (mg/L)	95% CI
1.5 Milligram (mg) LY2189265	-0.79	-1.27 – 0.14
0.75 Milligram (mg) LY2189265	-0.20	-1.05 – 0.75
Placebo	0.29	-1.13 – 0.02

Secondary/protocol endpoint

Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

Time frame:Baseline, 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)

Time frame:Baseline, 16 and 26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)

Time frame:Baseline, 16 and 26 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure

Time frame:Baseline, 16 and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)

Time frame:Baseline, 16 and 26 weeks

Mean arterial pressure

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)

Time frame:Baseline, 16 and 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)

Time frame:Baseline, 16 and 26 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)

Time frame:Baseline, 16 and 26 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure

Time frame:Baseline, 16 and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)

Time frame:Baseline, 16 and 26 weeks

Mean arterial pressure

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)

Time frame:Baseline, 16 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

16 endpoints

Secondary/registry result

Number of Participants With Treatment Emergent Adverse Events at 26 Weeks

Time frame:Baseline through 26 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), participants	95% CI
1.5 Milligram (mg) LY2189265	160	—
0.75 Milligram (mg) LY2189265	156	—
Placebo	162	—

Secondary/registry result

Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes

Time frame:Baseline, 16 and 26 weeks

change from baseline, descriptive

Posted result

Group	Value (median), units per liter	95% CI
1.5 Milligram (mg) LY2189265Amylase, Total, Week 16 (n=214, 227, 224)	6.00	-2.00 – 13.00
Amylase, Total, Week 26 (n=205, 220, 209)	7.00	-2.00 – 16.00
Amylase, Pancreas-derived, Wk 16 (n=213, 227, 224)	4.00	0.00 – 9.00
Amylase, Pancreas-derived, Wk 26 (n=204, 220, 209)	5.00	1.00 – 10.00
Lipase, Week 16 (n=214, 227, 224)	4.00	-2.00 – 14.00
Lipase, Week 26 (n=205, 220, 209)	6.00	-1.00 – 14.00
0.75 Milligram (mg) LY2189265Amylase, Total, Week 16 (n=214, 227, 224)	5.00	-3.00 – 14.00
Amylase, Total, Week 26 (n=205, 220, 209)	4.00	-2.00 – 15.50
Amylase, Pancreas-derived, Wk 16 (n=213, 227, 224)	3.00	-1.00 – 9.00
Amylase, Pancreas-derived, Wk 26 (n=204, 220, 209)	3.50	0.00 – 9.50
Lipase, Week 16 (n=214, 227, 224)	3.00	-4.00 – 12.00
Lipase, Week 26 (n=205, 220, 209)	5.00	-3.00 – 13.00
PlaceboAmylase, Total, Week 16 (n=214, 227, 224)	0.00	-6.00 – 7.00
Amylase, Total, Week 26 (n=205, 220, 209)	0.00	-5.00 – 6.00
Amylase, Pancreas-derived, Wk 16 (n=213, 227, 224)	1.00	-3.50 – 4.00
Amylase, Pancreas-derived, Wk 26 (n=204, 220, 209)	1.00	-3.00 – 4.00
Lipase, Week 16 (n=214, 227, 224)	-1.00	-7.00 – 6.00
Lipase, Week 26 (n=205, 220, 209)	0.00	-6.00 – 5.00

Secondary/registry result

Change From Baseline to 16 and 26 Weeks on Serum Calcitonin

Time frame:Baseline, 16 and 26 weeks

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), picograms per milliliter (pg/mL)	95% CI
1.5 Milligram (mg) LY2189265Week 16 (n=213, n=223, n=223)	-0.30	—
Week 26 (n=202, n=220, n=209)	-0.19	—
0.75 Milligram (mg) LY2189265Week 16 (n=213, n=223, n=223)	-0.03	—
Week 26 (n=202, n=220, n=209)	0.02	—
PlaceboWeek 16 (n=213, n=223, n=223)	-0.39	—
Week 26 (n=202, n=220, n=209)	-0.05	—

Secondary/registry result

Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 16 and 26 weeks

change from baseline, descriptive

componentsqtc f interval, pr interval

Posted result

Group	Value (least_squares_mean), milliseconds (msec)	95% CI
1.5 Milligram (mg) LY2189265QTcF Interval, Week 16 (n=248, n=250, n=246)	-2.31	—
QTcF Interval, Week 26 (n=248, n=250, n=246)	-1.73	—
PR Interval, Week 16 (n=248, n=250, n=244)	4.96	—
PR Interval, Week 26 (n=248, n=250, n=244)	3.32	—
0.75 Milligram (mg) LY2189265QTcF Interval, Week 16 (n=248, n=250, n=246)	-0.96	—
QTcF Interval, Week 26 (n=248, n=250, n=246)	-0.93	—
PR Interval, Week 16 (n=248, n=250, n=244)	3.67	—
PR Interval, Week 26 (n=248, n=250, n=244)	3.17	—
PlaceboQTcF Interval, Week 16 (n=248, n=250, n=246)	1.06	—
QTcF Interval, Week 26 (n=248, n=250, n=246)	1.26	—
PR Interval, Week 16 (n=248, n=250, n=244)	0.01	—
PR Interval, Week 26 (n=248, n=250, n=244)	-1.98	—

Secondary/registry result

Number of Events of Adjudicated Pancreatitis up to 26 Weeks

Time frame:Baseline through 26 weeks

Pancreatitis

event count, event

Posted result

Group	Value (number), events	95% CI
1.5 Milligram (mg) LY2189265	0	—
0.75 Milligram (mg) LY2189265	0	—
Placebo	0	—

Secondary/registry result

Anti-LY2189265 Antibodies

Time frame:Baseline, 16, 26, and 30 weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (number), participants	95% CI
1.5 Milligram (mg) LY2189265Week 16	2	—
Week 26	1	—
Week 30	0	—
0.75 Milligram (mg) LY2189265Week 16	0	—
Week 26	3	—
Week 30	1	—
PlaceboWeek 16	0	—
Week 26	0	—
Week 30	0	—

Secondary/registry result

Rate of Hypoglycemic Episodes

Time frame:Baseline, 16 and 26 weeks

event count, event

Posted result

Group	Value (mean), events per participant per 30 days	95% CI
1.5 Milligram (mg) LY2189265Severe	0	—
Documented Symptomatic	0.14	—
Asymptomatic	0.17	—
Nocturnal	0.06	—
Non-nocturnal	0.29	—
0.75 Milligram (mg) LY2189265Severe	0	—
Documented Symptomatic	0.16	—
Asymptomatic	0.15	—
Nocturnal	0.12	—
Non-nocturnal	0.26	—
PlaceboSevere	0	—
Documented Symptomatic	0.08	—
Asymptomatic	0.06	—
Nocturnal	0.03	—
Non-nocturnal	0.15	—

Secondary/registry result

Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)

Time frame:4, 8, 12, 16, and 26 weeks

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogramshour per liter (ngh/L)	95% CI
1.5 Milligram (mg) LY2189265	11208	—
0.75 Milligram (mg) LY2189265	5998	—

Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events at 26 Weeks

Time frame:Baseline through 26 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes

Time frame:Baseline, 16 and 26 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks on Serum Calcitonin

Time frame:Baseline, 16 and 26 weeks

Thyroid event

change from baseline, event

Secondary/protocol endpoint

Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

Time frame:Baseline, 16 and 26 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Number of Events of Adjudicated Pancreatitis up to 26 Weeks

Time frame:Baseline through 26 weeks

Pancreatitis

event count, event

Secondary/protocol endpoint

Anti-LY2189265 Antibodies

Time frame:Baseline, 16, 26, and 30 weeks

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Rate of Hypoglycemic Episodes

Time frame:Baseline, 16 and 26 weeks

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC)

Time frame:4, 8, 12, 16, and 26 weeks

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes.
Cardiovascular diabetology2023 Mar 9PMID36894938doi:10.1186/s12933-023-01775-xvia clinicaltrials gov reference derived + pubmed nct search

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.