A Study of LY2409021 in Patients With Type 2 Diabetes | NCT01241448

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

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	Drug: Placebo
2.5 mg LY2409021	Experimental	Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	Drug: LY2409021
10 mg LY2409021	Experimental	Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	Drug: LY2409021
20 mg LY2409021	Experimental	Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	Drug: LY2409021

Name	Type	Description	Arm Group Labels	Other Names
LY2409021	Drug	Administered Orally	10 mg LY2409021 2.5 mg LY2409021 20 mg LY2409021

Measure	Description	Time Frame
Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)	Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.	Baseline, 24 weeks

Measure	Description	Time Frame
Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)	Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.	Baseline, 24 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 milligram per day (mg/day).
Have a hemoglobin A1c (HbA1c) value of 7.0% to 10.5%, inclusive.
Have a body mass index (BMI) between 25 to 45 kilogram per meter squared (kg/m^2), inclusive.

In the opinion of the investigator, are capable and willing to:

Perform self-monitoring of blood glucose
Complete a study diary as required for this protocol
Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
Comply with treatment regimens
Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.

Exclusion Criteria:

Have more than 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
Have had a previous diagnosis of pancreatitis.
Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
Have poorly controlled hypertension (systolic blood pressure greater than or equal to 150 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg) as determined by the mean of three separate measurements.
Show evidence of labile blood pressure, including symptomatic postural hypotension.
Have any abnormality of the ECG that would impact patient safety or data interpretation.
Show clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
Have a current or previous diagnosis of Gilbert's disease.
Have previous or current diagnosis of Hepatitis B or C
Have a serum creatinine >2 milligrams per deciliter (mg/dL) or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening; patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1c (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have a personal or family history of pancreatic neoplasia.
Have non-fasting triglycerides >600 mg/dL.
Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations) or have received such therapy within 8 weeks prior to screening.
Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility, central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin greater than or equal to 1 grams per day (gm/day).
Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 milliliters (mL) of wine; 1.5 oz or 45 milliliter (mL) of distilled spirits).
Currently use drugs with a narrow therapeutic index (for example, digoxin, lithium, phenytoin, theophylline, and warfarin).
Currently use drugs that are known to prolong the QT interval.
Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
Have previously completed or withdrawn from this study or any other study investigating LY2409021.
Have known allergies to LY2409021 or related compounds.
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-4559) 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
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.		Burbank	California	91505

PubMed Identifier	Type	Citation	Retractions
40526184	Derived	Tan AYF, Schneck K, Garhyan P, Chan ECY, Tham LS. Evaluation of Four Semi-Mechanistic Models for Predicting Glycemic Control With a Glucagon Receptor Antagonist in People With Type 2 Diabetes. CPT Pharmacometrics Syst Pharmacol. 2025 Aug;14(8):1381-1390. doi: 10.1002/psp4.70058. Epub 2025 Jun 17.
26681715	Derived

ID	Title	Description
FG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
FG001	2.5 mg LY2409021

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 24 Week Endpoint in Hemoglobin A1c (HbA1c)

Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.

All participants randomly assigned to treatment with at least 1 post-baseline HbA1c measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the participants were randomly assigned.

Posted

Least Squares Mean

90% Confidence Interval

percentage of Hemoglobin A1c (HbA1c)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG003	20 mg LY2409021	20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Units	Counts
Participants	OG00061 OG00161 OG00263 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.15(-0.37 to 0.06) OG001-0.45(-0.65 to -0.25) OG002-0.78(-0.97 to -0.58) 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	Sixty-five randomized patients (45 completers) per arm were expected to provide at least 90% power to detect 0.8% HbA1c difference with placebo assuming a SD for change in HbA1c of 1.2% (0.05 1-sided type I error).	Mixed Models Analysis		0.094	No multiplicity adjustments were used to calculate the p-value.	Least Squares Mean Difference	-0.29			2-Sided	90	-0.58	-0.01					Superiority or Other

Secondary

Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG)

Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

All participants randomly assigned to treatment with at least 1 post-baseline laboratory FBG measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomly assigned.

Posted

Least Squares Mean

95% Confidence Interval

millimoles per liter (mmol/L)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile

SMBG profiles consisted of blood glucose values collected before and 2 hours after the 3 main meals and at 0300 hours (3:00 AM). Values represent mean of values collected same time on 3 separate days within a week prior to visit. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

All randomized patients with at least 1 post-baseline self-monitored glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

milligrams per deciliter (mg/dL)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021

Secondary

Change From Baseline to 24 Week Endpoint in Plasma Glucose

All randomized patients with at least 1 post-baseline plasma glucose measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

millimoles per liter (mmol/L)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

Change From Baseline to 24 Week Endpoint in Fasting Insulin

Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

All randomized patients with at least 1 post-baseline fasting insulin measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

picomoles per liter (pmol/L)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total

GLP-1 is cleaved from proglucagon to form the active peptide GLP-1. The active form promotes suppression of glucagon secretion. Total GLP-1 is the active GLP-1 and the Dipeptidyl Peptidase IV cleaved GLP-1 form. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

All randomized patients with at least 1 post-baseline GLP-1 active and total measurements (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

picomoles per liter (pmol/L)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021

Secondary

Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile

Fasting Lipid Profile included: Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, visit, and visit-by-treatment interaction.

All randomized patients with at least 1 post-baseline fasting lipid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

millimoles per liter (mmol/L)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total)

Subfraction included: Very Low Density Lipoprotein (VLDL) Total. Least squares mean use an analysis of covariance model. The model included baseline lipoprotein subfractions, metformin use and treatment.

All randomized patients with at least 1 post-baseline lipoprotein subfractions measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized, last observation carried forward (LOCF) principle was applied.

Posted

Least Squares Mean

Standard Error

nanomoles per liter (nmol/L)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

Change From Baseline to 24 Week Endpoint in Free Fatty Acids

Least squares mean use an analysis of covariance model. The model included baseline free fatty acid, metformin use and treatment.

All randomized patients with at least 1 post-baseline free fatty acid measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

Standard Error

picomoles per liter (pmol/L)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG003

Secondary

Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

HOMA-IR is a computer model (based on HOMA2) which uses fasting plasma insulin and glucose concentrations to estimate insulin resistance (HOMA-IR) as a proportion reference population (normal young adults). The normal reference population with normal function was indexed to 1.0. Higher values indicate increased insulin resistance. Least squares means of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

All randomized patients with at least 1 post-baseline HOMA-IR measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

proportion of normal reference populatio

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B

HOMA-B is a computer model (based on HOMA-2) that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Higher values indicate greater beta cell function. Least squares (LS) mean of the change from baseline is from a mixed-model repeated measures analysis (MMRM). The model included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

All randomized patients with at least 1 post-baseline HOMA-B measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

percent of normal reference population

Baseline, 24 week

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

Change From Baseline to 24 Week Endpoint in Weight

Least squares means were adjusted for baseline weight, metformin use, visit, treatment and visit by treatment interaction.

All randomized patients with at least 1 post-baseline weight measurement (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Least Squares Mean

95% Confidence Interval

kilograms (kg)

Baseline, 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG003

Secondary

Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021

Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.

All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Geometric Mean

Geometric Coefficient of Variation

liters per hour (L/hr)

Baseline up to 26 weeks

ID	Title	Description
OG000	LY2409021	2.5 mg, 10 mg or 20 mg LY2409021 taken orally once daily for 24 weeks

Units	Counts
Participants	OG000

Secondary

Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021

Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.

All randomized patients who received at least 1 one dose of study drug (excluding participant data from the excluded site); analyzed according to the treatment to which the patients were randomized.

Posted

Geometric Mean

Geometric Coefficient of Variation

liters (L)

Baseline up to 26 weeks

ID	Title	Description
OG000	LY2409021	2.5 mg, 10 mg or 20 mg LY2409021 taken orally once daily for 24 weeks

Units	Counts
Participants	OG000

Secondary

The Percentage of Participants Experiencing a Hypoglycemic Episode

All randomized participants who received at least 1 dose of study drug (excluding participant data from the excluded site).

Posted

Number

percentage of participants

Baseline through 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Secondary

The 30-Day Adjusted Rate of Hypoglycemic Episodes

A hypoglycemic episode is any event during which typical symptoms of hypoglycemia are observed or when the measured plasma glucose concentration is less than or equal to 70 milligrams per deciliter (mg/dL) [3.9 millimoles per liter (mmol/L)]. 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Outcome measure was not analyzed due to the limited number of hypoglycemic events observed.

Outcome measure was not analyzed due to the limited number of hypoglycemic events observed; therefore zero participants were analyzed.

Posted

Baseline through 24 weeks

ID	Title	Description
OG000	Placebo	Placebo orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
OG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG0030 events0 affected66 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0022 events2 affected66 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Type ii hyperlipidaemia	Congenital, familial and genetic disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Type v hyperlipidaemia	Congenital, familial and genetic disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0022 events1 affected66 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0022 events1 affected66 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Glaucoma	Eye disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected66 at risk EG0015 events3 affected65 at risk EG0020 events0 affected66 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected66 at risk EG0012 events2 affected65 at risk EG0024 events4 affected66 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0012 events1 affected65 at risk EG0022 events2 affected66 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0014 events4 affected65 at risk EG0021 events1 affected66 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events2 affected65 at risk EG0020 events0 affected66 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Asthenia	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Chest pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0013 events2 affected65 at risk EG0020 events0 affected66 at risk EG003
Fatigue	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0013 events2 affected65 at risk EG0021 events1 affected66 at risk EG003
Oedema peripheral	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Pain	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Pyrexia	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Thirst	General disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Food allergy	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Acarodermatitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Body tinea	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Bronchitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Cellulitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Hordeolum	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Influenza	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0013 events3 affected65 at risk EG0021 events1 affected66 at risk EG003
Laryngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected66 at risk EG0013 events3 affected65 at risk EG0024 events4 affected66 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Otitis externa	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Otitis media	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Sinusitis	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Viral infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0014 events4 affected65 at risk EG00211 events7 affected66 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events2 affected65 at risk EG0029 events7 affected66 at risk EG003
Bilirubin conjugated increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0023 events2 affected66 at risk EG003
Blood glucose increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Blood potassium decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Blood triglycerides increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0022 events2 affected66 at risk EG003
Colonoscopy	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Electrocardiogram qt prolonged	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Free fatty acids increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0026 events3 affected66 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Intermediate density lipoprotein increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Lipase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Liver function test abnormal	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Low density lipoprotein increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Occult blood positive	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Weight decreased	Investigations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Weight increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
White blood cell count increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0013 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Abnormal weight gain	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Increased appetite	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Vitamin d deficiency	Metabolism and nutrition disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0014 events4 affected65 at risk EG0022 events2 affected66 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected66 at risk EG0012 events2 affected65 at risk EG0023 events2 affected66 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0021 events1 affected66 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0014 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0013 events2 affected65 at risk EG0020 events0 affected66 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Cluster headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0022 events2 affected66 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0003 events3 affected66 at risk EG0014 events3 affected65 at risk EG0024 events4 affected66 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Migraine	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0003 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Radiculopathy	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Depression	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0014 events2 affected65 at risk EG0020 events0 affected66 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0013 events3 affected65 at risk EG0020 events0 affected66 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Panic disorder	Psychiatric disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Dental implantation	Surgical and medical procedures	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Plastic surgery to the face	Surgical and medical procedures	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Essential hypertension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Hypertension	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0002 events2 affected66 at risk EG0011 events1 affected65 at risk EG0020 events0 affected66 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Phlebitis	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Venous insufficiency	Vascular disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 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 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
BG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
BG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
BG003	20 mg LY2409021	20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
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 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	3	66	23	66
EG001	2.5 mg LY2409021	2.5 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	0	65	31	65
EG002	10 mg LY2409021	10 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	2	66	34	66
EG003	20 mg LY2409021	20 mg LY2409021 orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.	2	66	29	66

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG0030 events0 affected66 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 15.0	Systematic Assessment	EG0000 events0 affected66 at risk EG0010 events0 affected65 at risk EG0021 events1 affected66 at risk EG003
Cholecystectomy	Surgical and medical procedures	MedDRA 15.0	Systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected65 at risk EG0020 events0 affected66 at risk EG003