Study Of Safety And Efficacy Of Ertugliflozin (PF-0497172... | NCT01059825

NCT01059825

ID	Type	Description	Link
B1521006	Other Identifier	Pfizer protocol number
2009-017131-18	EudraCT 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
Placebo	Placebo Comparator	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Drug: Placebo to Ertugliflozin Drug: Placebo to Sitagliptin Drug: Metformin
Ertugliflozin 1 mg	Experimental	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Drug: Placebo to Ertugliflozin Drug: Ertugliflozin 1 mg Drug: Placebo to Sitagliptin Drug: Metformin
Ertugliflozin 5 mg	Experimental	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Drug: Placebo to Ertugliflozin Drug: Ertugliflozin 5 mg Drug: Placebo to Sitagliptin Drug: Metformin
Ertugliflozin 10 mg	Experimental	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Drug: Placebo to Ertugliflozin Drug: Ertugliflozin 5 mg Drug: Placebo to Sitagliptin Drug: Metformin
Ertugliflozin 25 mg	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo to Ertugliflozin	Drug	Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days	Ertugliflozin 1 mg Ertugliflozin 10 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Baseline Hemoglobin A1c (HbA1c)	HbA1c is measured as percent.	Baseline
Change From Baseline in HbA1c at Week 12	HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).	Baseline and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1C at Week 2	HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).	Baseline and Week 2
Change From Baseline in HbA1c at Week 4

Eligibility Module

Contacts/Locations Module

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25754396	Result	Amin NB, Wang X, Jain SM, Lee DS, Nucci G, Rusnak JM. Dose-ranging efficacy and safety study of ertugliflozin, a sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes on a background of metformin. Diabetes Obes Metab. 2015 Jun;17(6):591-598. doi: 10.1111/dom.12460. Epub 2015 Mar 31.
34213819	Derived

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
FG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days

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

HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

Of the 375 enrolled participants included in the metformin run-in period, 328 participants were randomized to 1 of 6 treatment groups.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
BG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
BG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
BG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
BG004	Ertugliflozin 25 mg	Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days
BG005	Sitagliptin 100 mg	Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

Title	Measurements
	OG0008.08± 0.14 OG0018.01± 0.17 OG0027.88± 0.13 OG003

Primary

Change From Baseline in HbA1c at Week 12

HbA1c is measured as percent. The change from baseline is the Week 12 HbA1c percent minus the Week 0 HbA1c percent (last observation carried forward [LOCF]).

Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 12.

Posted

Least Squares Mean

80% Confidence Interval

Percent

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Change From Baseline in HbA1C at Week 2

HbA1c is measured as percent. The change from baseline is the Week 2 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 2.

Posted

Least Squares Mean

80% Confidence Interval

Percent

Baseline and Week 2

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Change From Baseline in HbA1c at Week 4

HbA1c is measured as percent. The change from baseline is the Week 4 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 4.

Posted

Least Squares Mean

80% Confidence Interval

Percent

Baseline and Week 4

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Change From Baseline in HbA1c at Week 8

HbA1c is measured as percent. The change from baseline is the Week 8 HbA1c percent minus the Week 0 HbA1c percent (LOCF).

Analysis population included randomized participants who were treated, had a baseline HbA1c measurement and at least 1 post-baseline HbA1c measurement up to Week 8.

Posted

Least Squares Mean

80% Confidence Interval

Percent

Baseline and Week 8

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Baseline Body Weight

All randomized participants.

Posted

Mean

Standard Error

Baseline

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG004	Ertugliflozin 25 mg	Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Percent Change From Baseline in Body Weight at Week 12

The percent change from baseline is the ([Week 12 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 12.

Posted

Least Squares Mean

80% Confidence Interval

Percent change

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Percent Change From Baseline in Body Weight at Week 2

The percent change from baseline is the ([Week 2 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 2.

Posted

Least Squares Mean

80% Confidence Interval

Percent change

Baseline and Week 2

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Percent Change From Baseline in Body Weight at Week 4

The percent change from baseline is the ([Week 4 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 4.

Posted

Least Squares Mean

80% Confidence Interval

Percent change

Baseline and Week 4

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Percent Change From Baseline in Body Weight at Week 8

The percent change from baseline is the ([Week 8 body weight minus the Week 0 body weight] divided by the Week 0 body weight) X 100 (LOCF).

Analysis population included randomized participants who were treated, had a baseline body weight measurement and at least 1 post-baseline body weight measurement up to Week 8.

Posted

Least Squares Mean

80% Confidence Interval

Percent change

Baseline and Week 8

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Baseline Systolic Blood Pressure

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.

All randomized participants.

Posted

Mean

Standard Error

mmHg

Baseline

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Change From Baseline in Systolic Blood Pressure at Week 12

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

Analysis population included randomized participants who were treated, had a baseline systolic blood pressure measurement and at least 1 post-baseline systolic blood pressure measurement up to Week 12.

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Change From Baseline in Systolic Blood Pressure at Week 2

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 2

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Change From Baseline in Systolic Blood Pressure at Week 4

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 4

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Change From Baseline in Systolic Blood Pressure at Week 8

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 systolic blood pressure minus the Week 0 systolic blood pressure (LOCF).

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 8

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Baseline Diastolic Blood Pressure

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed.

All randomized participants.

Posted

Mean

Standard Error

mmHg

Baseline

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Change From Baseline in Diastolic Blood Pressure at Week 12

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 12 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

Analysis population included randomized participants who were treated, had a baseline diastolic blood pressure measurement and at least 1 post-baseline diastolic blood pressure measurement up to Week 12.

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Change From Baseline in Diastolic Blood Pressure at Week 2

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 2 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 2

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Change From Baseline in Diastolic Blood Pressure at Week 4

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 4 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 4

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Change From Baseline in Diastolic Blood Pressure at Week 8

Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. The change from baseline is the Week 8 diastolic blood pressure minus the Week 0 diastolic blood pressure (LOCF).

Posted

Least Squares Mean

80% Confidence Interval

mmHg

Baseline and Week 8

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Secondary

Baseline Fasting Plasma Glucose

Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

All randomized participants.

Posted

Mean

Standard Error

mg/dL

Baseline

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG004

Secondary

Change From Baseline in Fasting Plasma Glucose at Week 12

The change from baseline is the Week 12 FPG minus the Week 0 fasting plasma glucose (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 12.

Posted

Least Squares Mean

80% Confidence Interval

mg/dL

Baseline and Week 12

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Change From Baseline in Fasting Plasma Glucose at Week 2

The change from baseline is the Week 2 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 2.

Posted

Least Squares Mean

80% Confidence Interval

mg/dL

Baseline and Week 2

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Change From Baseline in Fasting Plasma Glucose at Week 4

The change from baseline is the Week 4 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 4.

Posted

Least Squares Mean

80% Confidence Interval

mg/dL

Baseline and Week 4

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Change From Baseline in Fasting Plasma Glucose at Week 8

The change from baseline is the Week 8 FPG minus the Week 0 FPG (LOCF). Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

Analysis population included randomized participants who were treated, had a baseline fasting plasma glucose measurement and at least 1 post-baseline fasting plasma glucose measurement up to Week 8.

Posted

Least Squares Mean

80% Confidence Interval

mg/dL

Baseline and Week 8

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Percentage of Participants Achieving HbA1c <7% at Week 12

Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

Analysis population excludes participants with missing Week 12 HbA1c measurement.

Posted

Number

Percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Percentage of Participants Achieving HbA1C <6.5% at Week 12

Laboratory measurements were performed after an overnight fast ≥8 hours in duration.

Analysis population excludes participants with missing Week 12 HbA1c measurement.

Posted

Number

Percentage of participants

Week 12

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

Secondary

Number of Participants Who Experienced an Advere Event (AE)

An adverse event is defines as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Below table includes all data collected since the first dose of sponsor-provided metformin.

All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).

Posted

Number

Participants

Up to 98 days

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003	Ertugliflozin 10 mg

Secondary

Number of Participants Who Discontinued Study Medication Due to an AE

All participants who received at least 1 dose of treatment (including sponsor-supplied metformin).

Posted

Number

Participants

Up to 84 days

ID	Title	Description
OG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days
OG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days
OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	0	54	13	54
EG001	Ertugliflozin 1 mg	Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	0	54	10	54
EG002	Ertugliflozin 5 mg	Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	2	55	14	55
EG003	Ertugliflozin 10 mg	Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	0	55	14	55
EG004	Ertugliflozin 25 mg	Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	1	55	10	55
EG005	Sitagliptin 100 mg	Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	1	55	12	55
EG006	Metformin Run-in	Participants received open-label metformin during the run-in period.	2	375	30	375

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0021 events1 affected55 at risk EG0030 events0 affected55 at risk EG0041 events1 affected55 at risk EG0050 events0 affected55 at risk EG0060 events0 affected375 at risk
Food allergy	Immune system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0020 events0 affected55 at risk EG003
Cellulitis	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0021 events1 affected55 at risk EG003
Syncope	Vascular disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0021 events1 affected55 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0020 events0 affected55 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0020 events0 affected55 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected54 at risk EG0012 events2 affected54 at risk EG0021 events1 affected55 at risk EG0032 events2 affected55 at risk EG0043 events3 affected55 at risk EG0054 events4 affected55 at risk EG00614 events14 affected375 at risk
Genital infection fungal	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected54 at risk EG0010 events0 affected54 at risk EG0022 events1 affected55 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected54 at risk EG0012 events2 affected54 at risk EG0022 events2 affected55 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.1	Systematic Assessment	EG0004 events4 affected54 at risk EG0012 events2 affected54 at risk EG0020 events0 affected55 at risk EG003
Blood pressure increased	Investigations	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected54 at risk EG0012 events1 affected54 at risk EG0021 events1 affected55 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0023 events3 affected55 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected54 at risk EG0012 events2 affected54 at risk EG0026 events6 affected55 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected54 at risk EG0010 events0 affected54 at risk EG0020 events0 affected55 at risk EG003
Headache	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0002 events2 affected54 at risk EG0011 events1 affected54 at risk EG0024 events4 affected55 at risk EG003

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
C570288	ertugliflozin
D000068900	Sitagliptin Phosphate
D008687	Metformin

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days

EG0040 events0 affected55 at risk

EG0050 events0 affected55 at risk

EG0061 events1 affected375 at risk

EG0040 events0 affected55 at risk

EG0050 events0 affected55 at risk

EG0060 events0 affected375 at risk

EG0040 events0 affected55 at risk

EG0050 events0 affected55 at risk

EG0060 events0 affected375 at risk

EG0040 events0 affected55 at risk

EG0051 events1 affected55 at risk

EG0060 events0 affected375 at risk

EG0040 events0 affected55 at risk

EG0050 events0 affected55 at risk

EG0061 events1 affected375 at risk

EG0044 events4 affected55 at risk

EG0050 events0 affected55 at risk

EG0062 events2 affected375 at risk

EG0043 events3 affected55 at risk

EG0052 events2 affected55 at risk

EG0061 events1 affected375 at risk

EG0040 events0 affected55 at risk

EG0052 events1 affected55 at risk

EG0064 events4 affected375 at risk

EG0041 events1 affected55 at risk

EG0053 events3 affected55 at risk

EG0060 events0 affected375 at risk

EG0041 events1 affected55 at risk

EG0050 events0 affected55 at risk

EG0065 events5 affected375 at risk

EG0042 events2 affected55 at risk

EG0050 events0 affected55 at risk

EG0064 events4 affected375 at risk

EG0040 events0 affected55 at risk

EG0053 events3 affected55 at risk

EG0061 events1 affected375 at risk

EG0041 events1 affected55 at risk

EG0051 events1 affected55 at risk

EG0064 events4 affected375 at risk

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