A Study of Dulaglutide (LY2189265) in Participants With T... | NCT02597049

ID	Type	Description	Link
H9X-MC-GBGE	Other Identifier	Eli Lilly and Company
2015-002095-24	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
1.5 mg Dulaglutide	Experimental	1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.	Drug: Dulaglutide Drug: SGLT2 inhibitor Drug: Metformin
0.75 mg Dulaglutide	Experimental	0.75 mg dulaglutide given SC once a week for 24 weeks.	Drug: Dulaglutide Drug: SGLT2 inhibitor Drug: Metformin
Placebo	Placebo Comparator	Placebo given SC once a week for 24 weeks.	Drug: Placebo Drug: SGLT2 inhibitor Drug: Metformin

Name	Type	Description	Arm Group Labels	Other Names
Dulaglutide	Drug	Administered SC	0.75 mg Dulaglutide 1.5 mg Dulaglutide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)	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.	Baseline, Week 24
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)	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.	Baseline, Week 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With HbA1c <7%	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.	24 Weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have type 2 diabetes mellitus (based on the World Health Organization's [WHO] diagnostic criteria)
Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed SGLT2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg [per country-specific label], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal [GI] intolerability)
Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of SGLT2 inhibitor and metformin, if used, will be considered stable during this period if:
- all prescribed daily doses were in the range between the minimum required dose and maximum-approved dose per country-specific label; and
- >90% of prescribed daily doses were equal to the dose at randomization
Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization
Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment

Exclusion Criteria:

Have type 1 diabetes mellitus
Have been treated with any other OAMs (other than SGLT2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary
Have any condition that is a contraindication for use of the GLP-1 RA class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization
Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
Had chronic or acute pancreatitis any time prior to study entry
Estimated glomerular filtration rate (eGFR) <45 milliliters(mL)/minute/1.73m^2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead in
Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes participants with a family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfect [RET]-negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for the RET mutation)
Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
Have a serum calcitonin ≥20 picograms/mL as determined by the central laboratory at study entry

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Medical Group of Encino		Encino	California	91436	United States
National Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36894938	Derived	Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
29483060	Derived	Ludvik B, Frias JP, Tinahones FJ, Wainstein J, Jiang H, Robertson KE, Garcia-Perez LE, Woodward DB, Milicevic Z. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 May;6(5):370-381. doi: 10.1016/S2213-8587(18)30023-8. Epub 2018 Feb 23.

Label	URL
Click here for more information about this study: A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	1.5 mg Dulaglutide	Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
FG001	0.75 mg Dulaglutide	Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: GBGE (a) Protocol	Aug 21, 2015

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG000142 ParticipantsBG001141 ParticipantsBG002140 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000142 ParticipantsBG001141 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000142 ParticipantsBG001141 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000142 ParticipantsBG001141 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
Austria	ParticipantsBG000142 ParticipantsBG001141 ParticipantsBG002

Baseline Mean Hemoglobin A1c (HbA1c) Treatment-Regimen Estimand

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

Mean

Standard Deviation

percentage of HbA1c

Title	Denominators	Categories
	ParticipantsBG000140 ParticipantsBG001139 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

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.

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

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline, Week 24

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts
Participants	OG000132 OG001134 OG002133

Title

Denominators

Categories

Title	Measurements
	OG000-1.34± 0.064 OG001-1.21± 0.064 OG002-0.54± 0.064

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis		<.001		Mean Difference (Final Values)	-0.79			2-Sided	95	-0.97	-0.61					Superiority
OG001 OG002		Mixed Models Analysis		< .001

Primary

Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

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.

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.

Posted

Least Squares Mean

Standard Error

percentage of HbA1c

Baseline, Week 24

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Secondary

Percentage of Participants With HbA1c <7%

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.

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

Posted

Number

percentage of participants

24 Weeks

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Body Weight at 24 Weeks

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

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

Posted

Least Squares Mean

Standard Error

kilograms (kg)

Baseline, Week 24

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks

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).

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

Posted

Least Squares Mean

Standard Error

milligram/deciliter (mg/dL)

Baseline, Week 24

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

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.

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

Posted

Least Squares Mean

Standard Error

mg/dL

Baseline, Week 24

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Secondary

Change From Baseline in Fasting Glucagon at 24 Weeks

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).

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.

Posted

Least Squares Mean

Standard Error

picomole per liter (pmol/L)

Baseline, Week 24

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts

Secondary

Rate of Hypoglycemic Events Adjusted Per 30 Days

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).

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

Posted

Mean

Standard Deviation

Number of events/participant/30 days

Baseline through 24 Weeks

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia

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.

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

Posted

Count of Participants

Participants

Baseline through 24 Weeks

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Adjudicated Acute Pancreatitis Events

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.

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

Posted

Count of Participants

Participants

Baseline through 24 Weeks

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Adjudicated Cardiovascular (CV) Events

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).

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

Posted

Count of Participants

Participants

Baseline through 24 Weeks

ID	Title	Description
OG000	1.5 mg Dulaglutide	Dulaglutide 1.5 mg given SC QW for 24 weeks.
OG001	0.75 mg Dulaglutide	Dulaglutide 0.75 milligrams (mg) given subcutaneously (SC) once a week (QW) for 24 weeks.
OG002	Placebo	Placebo given SC QW for 24 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0010 events0 affected141 at risk EG0022 events2 affected140 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0010 events0 affected141 at risk EG0021 events1 affected140 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0010 events0 affected141 at risk EG0021 events1 affected140 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0010 events0 affected141 at risk EG0021 events1 affected140 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0011 events1 affected141 at risk EG0020 events0 affected140 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected142 at risk EG0010 events0 affected141 at risk EG0020 events0 affected140 at risk
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected142 at risk EG0010 events0 affected141 at risk EG0020 events0 affected140 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected142 at risk EG0010 events0 affected141 at risk EG0020 events0 affected140 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0010 events0 affected141 at risk EG0021 events1 affected140 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0011 events1 affected141 at risk EG0020 events0 affected140 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0010 events0 affected141 at risk EG0021 events1 affected140 at risk
Spinal cord injury lumbar	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected142 at risk EG0010 events0 affected141 at risk EG0020 events0 affected140 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected72 at risk EG0020 events0 affected74 at risk
Endometrial sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected72 at risk EG0020 events0 affected74 at risk
Malignant neoplasm of conjunctiva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected142 at risk EG0010 events0 affected141 at risk EG0020 events0 affected140 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected77 at risk EG0010 events0 affected69 at risk EG0020 events0 affected66 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected142 at risk EG0011 events1 affected141 at risk EG0020 events0 affected140 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00010 events8 affected142 at risk EG00116 events14 affected141 at risk EG0025 events4 affected140 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG00032 events21 affected142 at risk EG00113 events7 affected141 at risk EG0026 events5 affected140 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00012 events9 affected142 at risk EG00110 events8 affected141 at risk EG00212 events11 affected140 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG00015 events13 affected142 at risk EG00114 events12 affected141 at risk EG00214 events10 affected140 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG00013 events8 affected142 at risk EG0018 events5 affected141 at risk EG00216 events13 affected140 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
C555680	dulaglutide
D000077203	Sodium-Glucose Transporter 2 Inhibitors
D000068896	Canagliflozin
C529054	dapagliflozin
C570240	empagliflozin
D008687	Metformin

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents
D045505	Physiological Effects of Drugs
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D001645	Biguanides
D006146	Guanidines
D000578	Amidines

ID	Title	Description
BG000	1.5 mg Dulaglutide	Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.
BG001	0.75 mg Dulaglutide	Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.
BG002	Placebo	Placebo given SC QW for 24 weeks.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1.5 mg Dulaglutide	Dulaglutide 1.5 milligrams (mg) given SC QW for 24 weeks.	2	142	5	142	43	142
EG001	0.75 mg Dulaglutide	Dulaglutide 0.75 mg given subcutaneously (SC) once a week (QW) for 24 weeks.	0	141	3	141	34	141
EG002	Placebo	Placebo given SC QW for 24 weeks.	0	140	5	140	29	140