A Study for Participants With Type 2 Diabetes Mellitus | NCT00871572

ID	Type	Description	Link
I1R-MC-GLBE	Other Identifier	Eli Lilly and Company

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
LY2409021 10 milligrams (mg)	Experimental	Drug: LY2409021
LY2409021 30 mg	Experimental	Drug: LY2409021
LY2409021 60 mg	Experimental	Drug: LY2409021

Name	Type	Description	Arm Group Labels	Other Names
LY2409021	Drug	4 capsules by mouth taken once daily for 12 weeks	LY2409021 10 milligrams (mg) LY2409021 30 mg LY2409021 60 mg

Measure	Description	Time Frame
Mean Change in Glycosylated 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) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.	Baseline, Week 12

Measure	Description	Time Frame
Change From Baseline Values for Fasting Blood Glucose (FBG)	LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.	Baseline, Week 12
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)

Eligibility Module

Eligibility Criteria

Inclusion:

Participants must either be male or a female who cannot become pregnant, who has type 2 diabetes and is either controlling your diabetes through diet and exercise alone, or with diet and exercise taking metformin.
If participants are male, participants are willing to talk to the study doctor about birth control options during the study and for 3 months after the last dose of study medication.
Participants must have an Hemoglobin A1c (HbA1c) test of 6.5% to 10%
Participants must have a body mass index (BMI) between 25 to 40 kilograms/square meter (kg/m²).
Participants must be willing and able to test your blood sugar levels at home with a blood sugar meter.
Participants must complete a study diary as instructed by your study doctor and staff and return the study diary as instructed by the study doctor.
Participants must maintain consistent dietary, physical activity, and sleeping patterns throughout the study.

Exclusion Criteria:

Insulin, exenatide, or any diabetic medication other than metformin 3 months prior to screening to control you diabetes,
Medications to increase movement in your digestive tract or that slow movement in your digestive tract
Over-the-counter drugs or drugs prescribed by your doctor that cause weight loss or high or low blood sugar,
Chronically use oral glucocorticoids therapy or have received this type of medication within 8 weeks prior to beginning this study,
Class II and III antiarrhythmic agents (commonly used to prevent or relieve an irregular heartbeat),
Drugs that damage the liver
Fibrates and niacin (both commonly used to treat high cholesterol) more than 1 gram/day (gm/day),
Central nervous stimulants, alcohol intake for males that is more than 2 units per day and for females that is more than 1 unit per day [1 unit=12 ounces (oz) or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits].
You have had one (1) or more cases of uncontrolled diabetes (very high blood sugars) which required hospitalization in the 6 months prior to the screening visit or have a diagnosis of hypoglycemia (low blood sugar) unawareness.
You had two (2) or more emergency room visits or were hospitalized for poor control of your diabetes (for example, keto-acidotic episode) in the last 6 months.
Participants have a problem with your stomach such that it empties slowly (diabetic gastroparesis) or you have had gastric bypass (bariatric) surgery.
Participants have a personal or family history of pancreatic neoplasia.
Participants have abnormal lipids (for example triglycerides).
Participants have had problems with your heart in the past 6 months, such as a heart attack, chest pain (angina), heart failure, heart bypass operation, angioplasty (a medical procedure to open a narrow or clogged blood vessel of the heart) or stent insertion (a procedure to insert a wire mesh tube to prop open a blood vessel after angioplasty), a heart rhythm problem, or a stroke.
Participants have an elevated or uncontrolled blood pressure.
Participant's electrocardiogram (ECG, a test that measures the electrical activity of your heart) is outside the normal limits, as determined by the study doctor.
Participants have a problem with your kidneys or are on dialysis.
Participants have a problem with your pancreas.
Participants must not have nor had liver disease (for example, Hepatitis B or C).
Participants have cancer, except for skin cancer or have been in remission (the absence of disease activity) from cancer for less than 5 years.
Participants have a serious or uncontrolled health problems (other than type 2 diabetes), blood disorders or laboratory tests that in the opinion of the doctor, could interfere with understanding the results of this study. The doctor will let you know if this applies to you.
Participants previously completed or withdrew from this study or any other study investigating LY2409021.
Participants are allergic to the study drug or other related drugs. You cannot be in this study if you are a woman and you possibly could become pregnant during this study.

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

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Buena Park	California	90620

PubMed Identifier	Type	Citation	Retractions
26681715	Derived	Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17.

ID	Title	Description
FG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
FG001	10 mg LY2409021	10 milligram (mg) LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.

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

Mean Change in Glycosylated 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) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.

Modified Intent-to-Treat (mITT): All randomized participants with at least 1 post baseline HbA1c measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

90% Confidence Interval

percentage of HbA1c

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Units	Counts
Participants	OG0008 OG00111 OG00231 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.11(-0.44 to 0.65) OG001-0.83(-1.28 to -0.38) OG002-0.65(-0.93 to -0.37) OG003

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 OG001		Mixed Models Analysis		0.0296		Mean Difference (Final Values)	-0.94			2-Sided	90	-1.64	-0.23					Superiority or Other
OG000 OG002		Mixed Models Analysis		0.0418

Secondary

Change From Baseline Values for Fasting Blood Glucose (FBG)

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

mITT: All randomized participants with at least 1 post baseline FBG measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

millimoles/liter (mmol/L)

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)

LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.

mITT: All randomized participants with at least 1 post baseline OGTT measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

mmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline to Endpoint for Fasting Triglycerides

LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.

mITT: All randomized participants with at least 1 post baseline fasting triglyceride measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

Standard Error

mmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)

The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.

mITT: All randomized participants with at least 1 post baseline DSC-R measurement and analyzed according to the assigned treatment.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)

The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.

mITT: All randomized participants with at least 1 post baseline Diabetes Medicines Survey measurement and analyzed according to the assigned treatment.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021

Secondary

Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles

Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

mITT: All randomized participants with at least 1 post baseline 7-Point SMBG measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

milligrams/deciliter (mg/dL)

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021

Secondary

Change From Baseline Values for Fasting Insulin

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

mITT: All randomized participants with at least 1 post baseline fasting insulin measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

picomole/liter (pmol/L)

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline Values for Fasting Glucagon

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

mITT: All randomized participants with at least 1 post baseline fasting glucagon measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

pmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

mITT: All randomized participants with at least 1 post baseline fasting GLP-1 measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

pmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline for Insulin AUC From OGTT

LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.

mITT: All randomized participants with at least 1 post baseline AUC from OGTT measurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

pmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline for C-Peptide AUC From OGTT

LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.

mITT: all randomized participants with at least 1 post baseline C-peptide AUC from OGTTmeasurement and analyzed according to the assigned treatment.

Posted

Least Squares Mean

95% Confidence Interval

pmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)

Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

mITT: All randomized participants with at least 1 post baseline fasting LDL measurement and analyzed according to the assigned treatment; last observation carried forward (LOCF).

Posted

Least Squares Mean

Standard Error

mmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline to Endpoint for High Density Lipoprotein (HDL)

Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

mITT: All randomized participants with at least 1 post baseline fasting HDL measurement and analyzed according to the assigned treatment; LOCF.

Posted

Least Squares Mean

Standard Error

mmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline to Endpoint for Non-HDL Cholesterol

Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.

mITT: All randomized participants with at least 1 post baseline fasting non-HDL cholesterol measurement and analyzed according to the assigned treatment; LOCF.

Posted

Least Squares Mean

Standard Error

mmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Secondary

Change From Baseline to Endpoint for Total Cholesterol

Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.

mITT: All randomized participants with at least 1 post baseline fasting total cholesterol measurement and analyzed according to the assigned treatment; LOCF.

Posted

Least Squares Mean

Standard Error

mmol/L

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
OG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
OG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
OG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sinus tachycardia	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG0031 events1 affected25 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0022 events2 affected34 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0023 events3 affected34 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0024 events4 affected34 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0012 events2 affected17 at risk EG0026 events2 affected34 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0021 events1 affected34 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0021 events1 affected34 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events2 affected9 at risk EG0011 events1 affected17 at risk EG0025 events5 affected34 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0021 events1 affected34 at risk EG003
Chest discomfort	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Fatigue	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0023 events3 affected34 at risk EG003
Influenza like illness	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG003
Pyrexia	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Thirst	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0022 events2 affected34 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Bronchitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0012 events2 affected17 at risk EG0020 events0 affected34 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0022 events2 affected34 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0022 events2 affected34 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0021 events1 affected34 at risk EG003
Blood pressure increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Electrocardiogram t wave abnormal	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Lipase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0023 events2 affected34 at risk EG003
Weight increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0024 events4 affected34 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0014 events3 affected17 at risk EG0024 events2 affected34 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0013 events3 affected17 at risk EG0020 events0 affected34 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0022 events2 affected34 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0022 events2 affected34 at risk EG003
Dizziness	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0013 events3 affected17 at risk EG0024 events2 affected34 at risk EG003
Headache	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected17 at risk EG0023 events2 affected34 at risk EG003
Lethargy	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 events1 affected9 at risk EG0011 events1 affected17 at risk EG0021 events1 affected34 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0025 events5 affected34 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG003
Hot flush	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Hypertension	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 events1 affected9 at risk EG0010 events0 affected17 at risk EG0021 events1 affected34 at risk EG003

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

ID	Title	Description
BG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.
BG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.
BG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.
BG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo was administered orally once daily as 4 capsules for 12 weeks.	0	9	6	9
EG001	10 mg LY2409021	10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks.	1	17	14	17
EG002	30 mg LY2409021	30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks.	0	34	25	34
EG003	60 mg LY2409021	60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks.	1	25	18	25

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0010 events0 affected17 at risk EG0020 events0 affected34 at risk EG0031 events1 affected25 at risk
Alanine aminotransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 events0 affected9 at risk EG0011 events1 affected17 at risk EG0020 events0 affected34 at risk EG003