Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729... | NCT02226003

NCT02226003

ID	Type	Description	Link
2014-001049-25	EudraCT Number
B1521047	Other Identifier	Pfizer Protocol Number

Status Module

Sponsor/Collaborators Module

Name	Class
Pfizer	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ertugliflozin 5 mg and Sitagliptin 100 mg	Experimental	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.	Drug: Ertugliflozin Drug: Sitagliptin Drug: Placebo to Ertugliflozin Drug: Glimepiride
Ertugliflozin 15 mg and Sitagliptin 100 mg	Experimental	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.	Drug: Ertugliflozin Drug: Sitagliptin Drug: Glimepiride
Placebo to Ertugliflozin and Placebo to Sitagliptin	Placebo Comparator	Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.	Drug: Placebo to Ertugliflozin Drug: Placebo to Sitagliptin Drug: Glimepiride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ertugliflozin	Drug	Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.	Ertugliflozin 15 mg and Sitagliptin 100 mg Ertugliflozin 5 mg and Sitagliptin 100 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach	HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.	Baseline and Week 26
Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach	An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.	Up to Week 28
Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach	An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.	Up to Week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach	Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 diabetes mellitus as per American Diabetes Association guidelines
Not on antihyperglycemic agent (AHA) >=8 weeks with a Visit 1/Screening HbA1C >=8.0% and <=10.5% (>=64 mmol/mol and <=91 mmol/mol) OR on single allowable AHA (allowable AHAs prior to screening are: metformin, α-glucosidase inhibitors, sulfonylureas and glinides) with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol) OR on low-dose dual combination therapy (≤50% of maximum labeled dose of an AHA) with allowable AHAs with a Visit 1/Screening HbA1C >=7.5% and <=10.0% (>=58 mmol/mol and <=86 mmol/mol)
Body mass index (BMI) >=18.0 kg/m^2
Male or female not of reproductive potential
Female of reproductive potential who agrees to (or have their partner agree to) remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.

Exclusion Criteria:

History of type 1 diabetes mellitus or diabetic ketoacidosis
History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant
A known hypersensitivity or intolerance to any sodium glucose co-transporter (SGLT2) inhibitor or sitagliptin
Has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: insulin of any type (except for short-term use [i.e., <=7 days] during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitors), bromocriptine (Cycloset™), colesevelam (Welchol™), any other AHA with the exception of the protocol-approved agents
Is on a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable prior to study start
Has undergone bariatric surgery within the past 12 months or >12 months and is not weight stable prior to study start
A history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional Class III-IV heart failure within 3 months of study start
Active, obstructive uropathy or indwelling urinary catheter
History of malignancy <=5 years prior to study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
A known history of human immunodeficiency virus (HIV)
A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
Any clinically significant malabsorption condition
Current treatment for hyperthyroidism
On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior study start
On a previous clinical study with ertugliflozin
Participated in other studies involving investigational drug(s) 30 days prior to study start
Surgical procedure within 6 weeks prior to study start or major surgery planned during the trial
Positive urine pregnancy test
Pregnant or breast-feeding, or planning to conceive during the trial, including 14 days following the last dose of study medication
Planning to undergo hormonal therapy in preparation for egg donation during the trial, including 14 days following the last dose of study medication
Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week or engages in binge drinking
Donated blood or blood products within 6 weeks of study start.

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29313282	Result	Miller S, Krumins T, Zhou H, Huyck S, Johnson J, Golm G, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. Diabetes Ther. 2018 Feb;9(1):253-268. doi: 10.1007/s13300-017-0358-0. Epub 2018 Jan 8.
32700393	Derived

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
FG001	Ertugliflozin 15 mg + Sitagliptin 100 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
BG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
BG002	Placebo	Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00098 BG00196 BG00297 BG003291

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-1.60(-1.82 to -1.39) OG001-1.68(-1.90 to -1.46) OG002-0.44(-0.69 to -0.19)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Constrained Longitudinal Data Analysis		< 0.001		Difference in the Least Squares Means	-1.16			2-Sided	95	-1.49	-0.84					Superiority or Other
OG001 OG002		Constrained Longitudinal Data Analysis

Primary

Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach

An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.

All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.

Posted

Number

Percentage of Participants

Up to Week 28

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002	Placebo

Primary

Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.

ASaT population consisted of all randomized participants who received at least one dose of a study drug.

Posted

Number

Percentage of Participants

Up to Week 26

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002	Placebo

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach

Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.

Posted

Least Squares Mean

95% Confidence Interval

milligrams/deciliter

Baseline and Week 26

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002	Placebo

Secondary

Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach

Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.

FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.

Posted

Least Squares Mean

95% Confidence Interval

milligrams/deciliter

Baseline and Week 26

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002	Placebo

Secondary

Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26

HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.

FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.

Posted

Number

Percentage of participants

Week 26

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002	Placebo	Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.

Secondary

Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach

Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.

Posted

Least Squares Mean

95% Confidence Interval

Kilograms

Baseline and Week 26

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002

Secondary

Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach

Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.

FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.

Posted

Least Squares Mean

95% Confidence Interval

millimeters of mercury

Baseline and Week 26

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002	Placebo

Secondary

Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach

The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.

Posted

Least Squares Mean

95% Confidence Interval

millimeters of mercury

Baseline and Week 26

ID	Title	Description
OG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
OG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
OG002	Placebo

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ertugliflozin 5 mg + Sitagliptin 100 mg	Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.	2	98	8	98
EG001	Ertugliflozin 15 mg + Sitagliptin 100 mg	Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.	3	96	3	96
EG002	Placebo	Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.	5	97	12	97

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ischaemic stroke	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0010 events0 affected96 at risk EG0021 events1 affected97 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0010 events0 affected96 at risk EG0021 events1 affected97 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0010 events0 affected96 at risk EG0021 events1 affected97 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected96 at risk EG0020 events0 affected97 at risk
Appendicitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0010 events0 affected96 at risk EG0021 events1 affected97 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0010 events0 affected96 at risk EG0021 events1 affected97 at risk
Peritonitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0010 events0 affected96 at risk EG0021 events1 affected97 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected96 at risk EG0020 events0 affected97 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0010 events0 affected96 at risk EG0021 events1 affected97 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 events1 affected98 at risk EG0010 events0 affected96 at risk EG0020 events0 affected97 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected96 at risk EG0020 events0 affected97 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected96 at risk EG0020 events0 affected97 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Blood glucose increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0004 events3 affected98 at risk EG0010 events0 affected96 at risk EG00214 events7 affected97 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0000 events0 affected98 at risk EG0011 events1 affected96 at risk EG0026 events6 affected97 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0006 events5 affected98 at risk EG0012 events2 affected96 at risk EG0021 events1 affected97 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
C570288	ertugliflozin
D000068900	Sitagliptin Phosphate
C057619	glimepiride

Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.

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

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines