Trial Outcomes & Findings for A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus (NCT NCT02597049)

Last Updated: 2020-06-17

Results Overview

Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

424 participants

Primary outcome timeframe

Baseline, Week 24

Results posted on

2020-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	1.5 mg Dulaglutide Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.	0.75 mg Dulaglutide Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo Placebo given SC QW for 24 weeks.
Overall Study STARTED	142	142	140
Overall Study Received at Least One Dose of Study Drug	142	141	140
Overall Study COMPLETED	135	137	137
Overall Study NOT COMPLETED	7	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	1.5 mg Dulaglutide Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.	0.75 mg Dulaglutide Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo Placebo given SC QW for 24 weeks.
Overall Study Lost to Follow-up	0	3	2
Overall Study Withdrawal by Subject	2	2	1
Overall Study Adverse Event	2	0	0
Overall Study Death	2	0	0
Overall Study Noncompliant with Study Visits	1	0	0

Baseline Characteristics

All randomized participants who received at least one dose of study drug and had a baseline measure of HbA1c.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.	Total n=423 Participants Total of all reporting groups
Age, Continuous	56.17 years STANDARD_DEVIATION 9.26 • n=142 Participants	58.55 years STANDARD_DEVIATION 9.14 • n=141 Participants	57.10 years STANDARD_DEVIATION 9.59 • n=140 Participants	57.27 years STANDARD_DEVIATION 9.36 • n=423 Participants
Sex: Female, Male Female	65 Participants n=142 Participants	72 Participants n=141 Participants	74 Participants n=140 Participants	211 Participants n=423 Participants
Sex: Female, Male Male	77 Participants n=142 Participants	69 Participants n=141 Participants	66 Participants n=140 Participants	212 Participants n=423 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	51 Participants n=142 Participants	44 Participants n=141 Participants	44 Participants n=140 Participants	139 Participants n=423 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=142 Participants	97 Participants n=141 Participants	94 Participants n=140 Participants	281 Participants n=423 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=142 Participants	0 Participants n=141 Participants	2 Participants n=140 Participants	3 Participants n=423 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=142 Participants	2 Participants n=141 Participants	4 Participants n=140 Participants	7 Participants n=423 Participants
Race (NIH/OMB) Asian	0 Participants n=142 Participants	1 Participants n=141 Participants	0 Participants n=140 Participants	1 Participants n=423 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=142 Participants	0 Participants n=141 Participants	0 Participants n=140 Participants	0 Participants n=423 Participants
Race (NIH/OMB) Black or African American	3 Participants n=142 Participants	3 Participants n=141 Participants	6 Participants n=140 Participants	12 Participants n=423 Participants
Race (NIH/OMB) White	127 Participants n=142 Participants	127 Participants n=141 Participants	124 Participants n=140 Participants	378 Participants n=423 Participants
Race (NIH/OMB) More than one race	11 Participants n=142 Participants	8 Participants n=141 Participants	6 Participants n=140 Participants	25 Participants n=423 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=142 Participants	0 Participants n=141 Participants	0 Participants n=140 Participants	0 Participants n=423 Participants
Region of Enrollment Austria	9 Participants n=142 Participants	11 Participants n=141 Participants	9 Participants n=140 Participants	29 Participants n=423 Participants
Region of Enrollment Hungary	19 Participants n=142 Participants	19 Participants n=141 Participants	19 Participants n=140 Participants	57 Participants n=423 Participants
Region of Enrollment United States	30 Participants n=142 Participants	30 Participants n=141 Participants	28 Participants n=140 Participants	88 Participants n=423 Participants
Region of Enrollment Czechia	25 Participants n=142 Participants	23 Participants n=141 Participants	25 Participants n=140 Participants	73 Participants n=423 Participants
Region of Enrollment Mexico	27 Participants n=142 Participants	28 Participants n=141 Participants	28 Participants n=140 Participants	83 Participants n=423 Participants
Region of Enrollment Israel	6 Participants n=142 Participants	6 Participants n=141 Participants	6 Participants n=140 Participants	18 Participants n=423 Participants
Region of Enrollment Germany	12 Participants n=142 Participants	11 Participants n=141 Participants	10 Participants n=140 Participants	33 Participants n=423 Participants
Region of Enrollment Spain	14 Participants n=142 Participants	13 Participants n=141 Participants	15 Participants n=140 Participants	42 Participants n=423 Participants
Baseline Mean Hemoglobin A1c (HbA1c) Treatment-Regimen Estimand	8.04 percentage of HbA1c STANDARD_DEVIATION 0.66 • n=140 Participants • All randomized participants who received at least one dose of study drug and had a baseline measure of HbA1c.	8.04 percentage of HbA1c STANDARD_DEVIATION 0.61 • n=139 Participants • All randomized participants who received at least one dose of study drug and had a baseline measure of HbA1c.	8.05 percentage of HbA1c STANDARD_DEVIATION 0.66 • n=137 Participants • All randomized participants who received at least one dose of study drug and had a baseline measure of HbA1c.	8.04 percentage of HbA1c STANDARD_DEVIATION 0.64 • n=416 Participants • All randomized participants who received at least one dose of study drug and had a baseline measure of HbA1c.

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study medication and had evaluable data.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=132 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=134 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=133 Participants Placebo given SC QW for 24 weeks.
Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)	-1.34 percentage of HbA1c Standard Error 0.064	-1.21 percentage of HbA1c Standard Error 0.064	-0.54 percentage of HbA1c Standard Error 0.064

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: All randomized participants who received at least one dose of study drug and had a baseline and post-baseline value excluding values collected after rescue medication.

LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=130 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=131 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=123 Participants Placebo given SC QW for 24 weeks.
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)	-1.33 percentage of HbA1c Standard Error 0.063	-1.19 percentage of HbA1c Standard Error 0.063	-0.51 percentage of HbA1c Standard Error 0.065

SECONDARY outcome

Timeframe: 24 Weeks

Population: All participants who received at least one dose of Dulaglutide with HbA1c \<7% at Week 24.

Number of participants with an HbA1c value of \<7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Percentage of Participants With HbA1c <7% Treatment-regimen Estimand	71.21 percentage of participants	60.45 percentage of participants	31.58 percentage of participants
Percentage of Participants With HbA1c <7% Efficacy Estimand	71.54 percentage of participants	61.83 percentage of participants	32.52 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All participants who received at least one dose of study drug.

LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Change From Baseline in Body Weight at 24 Weeks Treatment-regimen Estimand	-3.1 kilograms (kg) Standard Error 0.30	-2.6 kilograms (kg) Standard Error 0.30	-2.1 kilograms (kg) Standard Error 0.30
Change From Baseline in Body Weight at 24 Weeks Efficacy Estimand	-3.1 kilograms (kg) Standard Error 0.30	-2.6 kilograms (kg) Standard Error 0.30	-2.3 kilograms (kg) Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All participants who received at least one dose of study drug and had baseline and at least one post-baseline value.

LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA).

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks Treatment-regimen Estimand	-31.6 milligram/deciliter (mg/dL) Standard Error 2.17	-26.5 milligram/deciliter (mg/dL) Standard Error 2.18	-6.9 milligram/deciliter (mg/dL) Standard Error 2.21
Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks Efficacy Estimand	-31.9 milligram/deciliter (mg/dL) Standard Error 2.11	-26.0 milligram/deciliter (mg/dL) Standard Error 2.12	-5.3 milligram/deciliter (mg/dL) Standard Error 2.21

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All participants who received at least one dose of study drug and had baseline SMPG value and at least one post-baseline SMPG value.

The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks Pre-morning Morning Meal	-27.8 mg/dL Standard Error 2.13	-23.2 mg/dL Standard Error 2.17	-8.1 mg/dL Standard Error 2.14
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks 2-Hour Postprandial Morning Meal	-44.6 mg/dL Standard Error 3.31	-41.1 mg/dL Standard Error 3.30	-20.1 mg/dL Standard Error 3.33
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks Pre-Mid Day Meal	-26.0 mg/dL Standard Error 2.91	-22.0 mg/dL Standard Error 2.94	-7.7 mg/dL Standard Error 2.93
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks 2-Hour Postprandial Mid Day Meal	-31.8 mg/dL Standard Error 3.47	-25.5 mg/dL Standard Error 3.47	-12.8 mg/dL Standard Error 3.53
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks Pre-Evening Meal	-30.3 mg/dL Standard Error 2.85	-30.1 mg/dL Standard Error 2.93	-7.5 mg/dL Standard Error 2.91
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks 2-Hour Postprandial Evening Meal	-36.0 mg/dL Standard Error 3.30	-30.6 mg/dL Standard Error 3.31	-13.9 mg/dL Standard Error 3.38

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: All participants who received at least one dose of study drug and with non-missing baseline values and at least one post-baseline value at the specified time point.

Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data).

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Change From Baseline in Fasting Glucagon at 24 Weeks Treatment-regimen Estimand	-2.1 picomole per liter (pmol/L) Standard Error 0.39	-1.5 picomole per liter (pmol/L) Standard Error 0.39	-0.9 picomole per liter (pmol/L) Standard Error 0.40
Change From Baseline in Fasting Glucagon at 24 Weeks Efficacy Estimand	-2.2 picomole per liter (pmol/L) Standard Error 0.39	-1.4 picomole per liter (pmol/L) Standard Error 0.39	-0.9 picomole per liter (pmol/L) Standard Error 0.41

SECONDARY outcome

Timeframe: Baseline through 24 Weeks

Population: All participants who received at least one dose of study drug.

A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L).

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Rate of Hypoglycemic Events Adjusted Per 30 Days Nocturnal Hypoglycemia	0.002 Number of events/participant/30 days Standard Deviation 0.0288	0.009 Number of events/participant/30 days Standard Deviation 0.0821	0.000 Number of events/participant/30 days Standard Deviation 0.0000
Rate of Hypoglycemic Events Adjusted Per 30 Days Total Hypoglycemia	0.026 Number of events/participant/30 days Standard Deviation 0.1827	0.022 Number of events/participant/30 days Standard Deviation 0.1375	0.017 Number of events/participant/30 days Standard Deviation 0.1320
Rate of Hypoglycemic Events Adjusted Per 30 Days Documented Symptomatic Hypoglycemia	0.013 Number of events/participant/30 days Standard Deviation 0.1406	0.013 Number of events/participant/30 days Standard Deviation 0.1030	0.010 Number of events/participant/30 days Standard Deviation 0.0893
Rate of Hypoglycemic Events Adjusted Per 30 Days Asymptomatic Hypoglycemia	0.013 Number of events/participant/30 days Standard Deviation 0.1180	0.008 Number of events/participant/30 days Standard Deviation 0.0639	0.006 Number of events/participant/30 days Standard Deviation 0.0540
Rate of Hypoglycemic Events Adjusted Per 30 Days Probable Symptomatic	0.000 Number of events/participant/30 days Standard Deviation 0.0000	0.001 Number of events/participant/30 days Standard Deviation 0.0152	0.001 Number of events/participant/30 days Standard Deviation 0.0147
Rate of Hypoglycemic Events Adjusted Per 30 Days Relative Hypoglycemia	0.003 Number of events/participant/30 days Standard Deviation 0.0311	0.001 Number of events/participant/30 days Standard Deviation 0.0150	0.005 Number of events/participant/30 days Standard Deviation 0.0493

SECONDARY outcome

Timeframe: Baseline through 24 Weeks

Population: All participants who had at least one dose of study drug.

Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia	0 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline through 24 Weeks

Population: All participants who received at least one dose of study drug.

The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor. A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Number of Participants With Adjudicated Acute Pancreatitis Events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline through 24 Weeks

Population: All participants who received at least one dose of study drug.

Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA).

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=142 Participants Dulaglutide 1.5 mg given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 Participants Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 Participants Placebo given SC QW for 24 weeks.
Number of Participants With Adjudicated Cardiovascular (CV) Events Any CV Event	0 Participants	0 Participants	3 Participants
Number of Participants With Adjudicated Cardiovascular (CV) Events Fatal CV Event	0 Participants	0 Participants	0 Participants
Number of Participants With Adjudicated Cardiovascular (CV) Events Non-fatal CV Event	0 Participants	0 Participants	3 Participants

Adverse Events

1.5 mg Dulaglutide

Serious events: 5 serious events

Other events: 43 other events

Deaths: 2 deaths

0.75 mg Dulaglutide

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	1.5 mg Dulaglutide n=142 participants at risk Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 participants at risk Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 participants at risk Placebo given SC QW for 24 weeks.
Gastrointestinal disorders Diarrhoea	5.6% 8/142 • Number of events 10 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	9.9% 14/141 • Number of events 16 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	2.9% 4/140 • Number of events 5 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	14.8% 21/142 • Number of events 32 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	5.0% 7/141 • Number of events 13 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	3.6% 5/140 • Number of events 6 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	6.3% 9/142 • Number of events 12 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	5.7% 8/141 • Number of events 10 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	7.9% 11/140 • Number of events 12 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	9.2% 13/142 • Number of events 15 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	8.5% 12/141 • Number of events 14 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	7.1% 10/140 • Number of events 14 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Nervous system disorders Headache	5.6% 8/142 • Number of events 13 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	3.5% 5/141 • Number of events 8 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	9.3% 13/140 • Number of events 16 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	1.5 mg Dulaglutide n=142 participants at risk Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.	0.75 mg Dulaglutide n=141 participants at risk Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.	Placebo n=140 participants at risk Placebo given SC QW for 24 weeks.
Cardiac disorders Angina unstable	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	1.4% 2/140 • Number of events 2 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/140 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Cardiac disorders Atrial tachycardia	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/140 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/140 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/141 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	0.70% 1/142 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Infections and infestations Erysipelas	0.70% 1/142 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.70% 1/142 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Infections and infestations Sepsis	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/140 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/141 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Injury	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/140 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal cord injury lumbar	0.70% 1/142 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	1.5% 1/65 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/72 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/74 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial sarcoma	1.5% 1/65 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/72 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/74 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of conjunctiva	0.70% 1/142 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/141 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.3% 1/77 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/69 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/66 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/142 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.71% 1/141 • Number of events 1 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.	0.00% 0/140 • Baseline to end of study (up to 24 weeks) All participants who received at least one dose of study drug.