A Study of LY2409021 in Participants With Type 2 Diabetes... | NCT02111096

ID	Type	Description	Link
I1R-MC-GLDJ	Other Identifier	Eli Lilly and Company
2013-004275-12	EudraCT Number

Label	Type	Description	Intervention Names
LY2409021	Experimental	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.	Drug: LY2409021 Drug: Metformin Drug: Sulfonylurea
Sitagliptin	Active Comparator	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.	Drug: Sitagliptin Drug: Metformin Drug: Sulfonylurea
Placebo	Placebo Comparator	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.	Drug: Placebo Drug: Metformin Drug: Sulfonylurea

Name	Type	Description	Arm Group Labels	Other Names
LY2409021	Drug	Administered orally	LY2409021
Sitagliptin

Measure	Description	Time Frame
Change From Baseline to 6 Months in Hepatic Fat Fraction	The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.	Baseline, 6 months

Measure	Description	Time Frame
Change From Baseline to 6 Months in Alanine Aminotransferase Levels	Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.	Baseline, 6 months

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
John Muir Health Network - The Osteoporosis Center		Concord	California	94520	United States
Valley Endocrine, Fresno

PubMed Identifier	Type	Citation	Retractions
28191913	Derived	Kazda CM, Frias J, Foga I, Cui X, Guzman CB, Garhyan P, Heilmann C, Yang JA, Hardy TA. Treatment with the glucagon receptor antagonist LY2409021 increases ambulatory blood pressure in patients with type 2 diabetes. Diabetes Obes Metab. 2017 Aug;19(8):1071-1077. doi: 10.1111/dom.12904. Epub 2017 Mar 27.

ID	Title	Description
FG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
FG001	Sitagliptin

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 to 6 Months in Hepatic Fat Fraction

The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of study drug, have usable MRI HFF data at baseline and at least 1 post-baseline time point, excluding any data collected after stopping study drug.

Posted

Least Squares Mean

95% Confidence Interval

percentage

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Units	Counts
Participants	OG00062 OG00139 OG00267

Title

Denominators

Categories

Title	Measurements
	OG0003.65(2.13 to 5.17) OG001-0.07(-1.94 to 1.79) OG002-0.79(-2.28 to 0.70)

Secondary

Change From Baseline to 6 Months in Alanine Aminotransferase Levels

Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of study drug, baseline data and at least 1 post-baseline time point.

Posted

Least Squares Mean

95% Confidence Interval

microgram per Liter (µ/L)

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Number of Participants With Hepatobiliary Adverse Events of Special Interest (AESI)

Number of participants with ALT or AST greater than 3 times the upper limit of normal at a post-baseline visit. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

All randomized participants who received at least 1 dose of study drug.

Posted

Count of Participants

Participants

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Change From Baseline to 6 Months in Fasting Lipids Levels

Lipid values (cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of randomized study drug, have data at baseline and at least 1 post-baseline time point.

Posted

Least Squares Mean

95% Confidence Interval

millimol per liter (mmol/L)

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Change From Baseline to 6 Months in Fasting Blood Glucagon

Glucagon values assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.

Posted

Least Squares Mean

95% Confidence Interval

picomol per liter (pmol/L)

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Change From Baseline to 6 Months in Body Weight

Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.

Posted

Least Squares Mean

90% Confidence Interval

kilograms (kg)

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Change From Baseline to 6 Months in Hemoglobin A1c (HbA1c)

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.

Posted

Least Squares Mean

95% Confidence Interval

percent of HbA1c

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Change From Baseline to 6 Months in Fasting Plasma Glucose

All randomized participants who received at least 1 dose of study drug,have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.

Posted

Least Squares Mean

95% Confidence Interval

milligram per decililiter (mg/dL)

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Change From Baseline to 6 Months in Blood Pressure

Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured in triplicate throughout the study. At each visit, all available blood pressure measurements for a subject were averaged to provide the blood pressure for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.

Posted

Least Squares Mean

95% Confidence Interval

millimeters of mercury (mm/Hg)

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo

Secondary

Change From Baseline to 6 Months in Pulse Rate

Seated pulse rate was measured in triplicate throughout the study. At each visit, all available pulse measurements for a subject were averaged to provide the pulse for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.

Posted

Least Squares Mean

95% Confidence Interval

beats per minutes (bpm)

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Change From Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)

7-point profile consists of pre-meal and 2-hour postprandial SMBG measurements for the morning, midday, and evening meals in 1 day and at 3 AM (nocturnal blood glucose measurement). Pre-meal measurements were taken before the subject began eating the meal. Participants recorded their glucose measurements in their study diaries.

Posted

Mean

Standard Deviation

mg/dL

Baseline, 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Population Pharmacokinetics: Apparent Clearance of LY2409021

Reported as a Population Estimate with % Standard Errors of Estimation (SEE), 5th-95th confidence interval.

All randomized participants who received at least 1 dose of study drug and had evaluable PK data.

Posted

Number

95% Confidence Interval

Liters per hour (L/h)

Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Units	Counts
Participants	OG000

Secondary

Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021

All participants who received at least 1 dose of study drug and had evaluable PK data.

Posted

Number

95% Confidence Interval

Liters (L)

Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Units	Counts
Participants	OG00065

Secondary

Rate of Hypoglycemic Events Adjusted Per 30 Days

Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L),is presented. Rate: (30 days) is calculated as: (number of episodes during the time period divided by the number of days during the time period) multiplied by 30.

Posted

Number

number of episodes per day

Baseline through 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Secondary

Number of Participants With Hypoglycemic Events

Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L), is presented. The number of subjects with an event are subjects who had at least one episode of documented symptomatic hypoglycemia during the time period.

All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after study drug and/or starting rescue therapy.

Posted

Count of Participants

Participants

Baseline through 6 months

ID	Title	Description
OG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
OG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected41 at risk EG0021 events1 affected68 at risk
Abscess limb	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Device related infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Infectious colitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events1 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Hypertensive crisis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Malignant hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Type v hyperlipidaemia	Congenital, familial and genetic disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0022 events2 affected68 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Blindness unilateral	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Eye swelling	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Glaucoma	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected41 at risk EG0021 events1 affected68 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0013 events3 affected41 at risk EG0020 events0 affected68 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 events3 affected65 at risk EG0011 events1 affected41 at risk EG0025 events3 affected68 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0010 events0 affected41 at risk EG0022 events2 affected68 at risk
Chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Fatigue	General disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0013 events2 affected41 at risk EG0020 events0 affected68 at risk
Pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Polyp	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0010 events0 affected41 at risk EG0022 events2 affected68 at risk
Pyrexia	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Allergy to vaccine	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Seasonal allergy	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Bronchitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0013 events3 affected41 at risk EG0020 events0 affected68 at risk
Conjunctivitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Influenza	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0012 events2 affected41 at risk EG0021 events1 affected68 at risk
Labyrinthitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0003 events2 affected65 at risk EG0013 events2 affected41 at risk EG0021 events1 affected68 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected41 at risk EG0021 events1 affected68 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Sinusitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0010 events0 affected41 at risk EG0021 events1 affected68 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0021 events1 affected68 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0006 events4 affected65 at risk EG0013 events3 affected41 at risk EG0024 events3 affected68 at risk
Viral infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0004 events2 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0021 events1 affected68 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Blood pressure diastolic increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Free fatty acids increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected41 at risk EG0021 events1 affected68 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected41 at risk EG0022 events2 affected68 at risk
Heart rate increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0012 events2 affected41 at risk EG0020 events0 affected68 at risk
Weight decreased	Investigations	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Weight increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected41 at risk EG0021 events1 affected68 at risk
Abnormal weight gain	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0010 events0 affected41 at risk EG0022 events1 affected68 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected65 at risk EG0011 events1 affected41 at risk EG0021 events1 affected68 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0013 events2 affected41 at risk EG0020 events0 affected68 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Dizziness	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0005 events4 affected65 at risk EG0010 events0 affected41 at risk EG0020 events0 affected68 at risk
Headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0008 events6 affected65 at risk EG0018 events2 affected41 at risk EG0021 events1 affected68 at risk
Tension headache	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected65 at risk EG0011 events1 affected41 at risk EG0020 events0 affected68 at risk
Hypertension	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0002 events2 affected65 at risk EG0011 events1 affected41 at risk EG0023 events3 affected68 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
C000601762	adomeglivant
D000068900	Sitagliptin Phosphate
D008687	Metformin
D013453	Sulfonylurea Compounds

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D014508	Urea
D000577	Amides
D013450	Sulfones
D013457	Sulfur Compounds

ID	Title	Description
BG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
BG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
BG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LY2409021	20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.	5	65	26	65
EG001	Sitagliptin	100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.	5	41	22	41
EG002	Placebo	Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.	1	68	21	68