Trial Outcomes & Findings for Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016) (NCT NCT01059825)

Results Overview

HbA1c is measured as percent.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

375 participants

Primary outcome timeframe

Baseline

Results posted on

2018-09-13

Participant Flow

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

Participant milestones

Participant milestones
Measure	Placebo Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	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	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	Ertugliflozin 10 mg Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Enrolled, Run-in Period STARTED	0	0	0	0	0	0	375
Enrolled, Run-in Period COMPLETED	0	0	0	0	0	0	328
Enrolled, Run-in Period NOT COMPLETED	0	0	0	0	0	0	47
Treatment Period STARTED	54	54	55	55	55	55	0
Treatment Period COMPLETED	44	50	49	44	47	52	0
Treatment Period NOT COMPLETED	10	4	6	11	8	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	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	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	Ertugliflozin 10 mg Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Enrolled, Run-in Period Adverse event not related to study drug	0	0	0	0	0	0	3
Enrolled, Run-in Period Did not meet entrance criteria	0	0	0	0	0	0	14
Enrolled, Run-in Period Lost to Follow-up	0	0	0	0	0	0	5
Enrolled, Run-in Period Withdrawal by Subject	0	0	0	0	0	0	13
Enrolled, Run-in Period Other reason not specified	0	0	0	0	0	0	7
Enrolled, Run-in Period Protocol Violation	0	0	0	0	0	0	5
Treatment Period Lost to Follow-up	2	1	0	1	2	0	0
Treatment Period Withdrawal by Subject	3	0	1	5	4	1	0
Treatment Period Other reason not specified	1	2	1	2	0	0	0
Treatment Period Protocol Violation	0	0	1	1	1	1	0
Treatment Period Adverse event related to study drug	1	0	1	1	0	0	0
Treatment Period Insufficient clinical response	3	0	0	0	0	0	0
Treatment Period Adverse event not related to study drug	0	1	2	1	1	1	0

Baseline Characteristics

Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Total n=328 Participants Total of all reporting groups
Age, Customized < 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized 18-44 years	8 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants	13 Participants n=8 Participants	47 Participants n=8 Participants
Age, Customized 45-64 years	41 Participants n=5 Participants	36 Participants n=7 Participants	42 Participants n=5 Participants	47 Participants n=4 Participants	39 Participants n=21 Participants	33 Participants n=8 Participants	238 Participants n=8 Participants
Age, Customized >= 65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	9 Participants n=8 Participants	43 Participants n=8 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	20 Participants n=7 Participants	14 Participants n=5 Participants	24 Participants n=4 Participants	18 Participants n=21 Participants	15 Participants n=8 Participants	115 Participants n=8 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	34 Participants n=7 Participants	41 Participants n=5 Participants	31 Participants n=4 Participants	37 Participants n=21 Participants	40 Participants n=8 Participants	213 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All randomized participants.

HbA1c is measured as percent.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Baseline Hemoglobin A1c (HbA1c)	8.08 Percent Standard Error 0.14	8.01 Percent Standard Error 0.17	7.88 Percent Standard Error 0.13	8.13 Percent Standard Error 0.17	8.30 Percent Standard Error 0.16	8.24 Percent Standard Error 0.15	—

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: 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.

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 \[LOCF\]).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in HbA1c at Week 12	-0.11 Percent Interval -0.25 to 0.04	-0.56 Percent Interval -0.69 to -0.42	-0.80 Percent Interval -0.94 to -0.66	-0.73 Percent Interval -0.87 to -0.58	-0.83 Percent Interval -0.98 to -0.69	-0.87 Percent Interval -1.01 to -0.73	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: 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.

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

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=52 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=49 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=50 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=49 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=51 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in HbA1C at Week 2	0.00 Percent Interval -0.08 to 0.07	-0.14 Percent Interval -0.21 to -0.06	-0.29 Percent Interval -0.36 to -0.21	-0.22 Percent Interval -0.29 to -0.15	-0.17 Percent Interval -0.25 to -0.1	-0.26 Percent Interval -0.33 to -0.18	—

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in HbA1c at Week 4	-0.04 Percent Interval -0.13 to 0.06	-0.40 Percent Interval -0.5 to -0.31	-0.49 Percent Interval -0.59 to -0.4	-0.48 Percent Interval -0.57 to -0.38	-0.40 Percent Interval -0.49 to -0.3	-0.48 Percent Interval -0.57 to -0.38	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

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

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in HbA1c at Week 8	-0.10 Percent Interval -0.22 to -0.02	-0.57 Percent Interval -0.69 to -0.45	-0.76 Percent Interval -0.88 to -0.64	-0.73 Percent Interval -0.85 to -0.6	-0.75 Percent Interval -0.87 to -0.62	-0.77 Percent Interval -0.89 to -0.65	—

SECONDARY outcome

Timeframe: Baseline

Population: All randomized participants.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Baseline Body Weight	83.78 kg Standard Error 2.37	83.44 kg Standard Error 2.57	85.74 kg Standard Error 2.82	82.28 kg Standard Error 2.93	81.81 kg Standard Error 2.34	85.52 kg Standard Error 2.61	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Percent Change From Baseline in Body Weight at Week 12	-0.75 Percent change Interval -1.18 to -0.32	-1.90 Percent change Interval -2.32 to -1.48	-2.50 Percent change Interval -2.92 to -2.07	-2.90 Percent change Interval -3.33 to -2.47	-2.66 Percent change Interval -3.1 to -2.23	-0.30 Percent change Interval -0.72 to 0.13	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=52 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=48 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=50 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=49 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=50 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Percent Change From Baseline in Body Weight at Week 2	-0.24 Percent change Interval -0.46 to -0.02	-0.65 Percent change Interval -0.87 to -0.44	-1.36 Percent change Interval -1.59 to -1.14	-1.14 Percent change Interval -1.36 to -0.92	-1.11 Percent change Interval -1.33 to -0.88	0.21 Percent change Interval -0.01 to 0.43	—

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=52 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Percent Change From Baseline in Body Weight at Week 4	-0.44 Percent change Interval -0.73 to -0.15	-1.20 Percent change Interval -1.48 to -0.92	-1.76 Percent change Interval -2.04 to -1.48	-1.68 Percent change Interval -1.97 to -1.39	-1.52 Percent change Interval -1.81 to -1.23	0.01 Percent change Interval -0.28 to 0.3	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Percent Change From Baseline in Body Weight at Week 8	-0.62 Percent change Interval -0.96 to -0.28	-1.65 Percent change Interval -1.98 to -1.32	-2.18 Percent change Interval -2.52 to -1.85	-2.30 Percent change Interval -2.64 to -1.96	-2.40 Percent change Interval -2.74 to -2.06	-0.38 Percent change Interval -0.71 to -0.05	—

SECONDARY outcome

Timeframe: Baseline

Population: All randomized participants.

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

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Baseline Systolic Blood Pressure	126.7 mmHg Standard Error 1.71	126.5 mmHg Standard Error 2.18	127.9 mmHg Standard Error 2.31	125.8 mmHg Standard Error 1.97	124.9 mmHg Standard Error 2.20	126.6 mmHg Standard Error 1.83	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Systolic Blood Pressure at Week 12	-0.55 mmHg Interval -2.55 to 1.44	-2.69 mmHg Interval -4.63 to -0.75	-4.03 mmHg Interval -5.99 to -2.07	-3.43 mmHg Interval -5.43 to -1.43	-3.93 mmHg Interval -5.94 to -1.91	-1.09 mmHg Interval -3.05 to 0.87	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: 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 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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=52 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=49 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=50 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=49 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=50 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Systolic Blood Pressure at Week 2	-1.93 mmHg Interval -3.73 to -0.12	-2.30 mmHg Interval -4.08 to -0.51	-4.73 mmHg Interval -6.57 to -2.89	-2.28 mmHg Interval -4.1 to -0.45	-5.39 mmHg Interval -7.23 to -3.55	-0.91 mmHg Interval -2.74 to 0.91	—

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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 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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=52 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Systolic Blood Pressure at Week 4	-2.57 mmHg Interval -4.31 to -0.82	-3.94 mmHg Interval -5.64 to -2.25	-5.15 mmHg Interval -6.86 to -3.44	-5.43 mmHg Interval -7.17 to -3.69	-3.33 mmHg Interval -5.09 to -1.57	-3.32 mmHg Interval -5.05 to -1.6	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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 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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Systolic Blood Pressure at Week 8	-0.44 mmHg Interval -2.42 to 1.55	-1.53 mmHg Interval -3.46 to 0.4	-2.85 mmHg Interval -4.8 to -0.9	-3.04 mmHg Interval -5.03 to -1.06	-3.30 mmHg Interval -5.31 to -1.3	-2.43 mmHg Interval -4.38 to -0.48	—

SECONDARY outcome

Timeframe: Baseline

Population: All randomized participants.

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

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Baseline Diastolic Blood Pressure	79.14 mmHg Standard Error 1.24	78.95 mmHg Standard Error 1.14	78.19 mmHg Standard Error 1.36	78.45 mmHg Standard Error 1.32	78.61 mmHg Standard Error 1.24	79.15 mmHg Standard Error 1.01	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Diastolic Blood Pressure at Week 12	0.81 mmHg Interval -0.41 to 2.02	-1.12 mmHg Interval -2.3 to 0.06	-1.01 mmHg Interval -2.2 to 0.18	-3.18 mmHg Interval -4.4 to -1.97	-1.83 mmHg Interval -3.06 to -0.61	1.68 mmHg Interval 0.49 to 2.87	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: 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 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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=52 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=49 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=50 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=49 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=50 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Diastolic Blood Pressure at Week 2	-0.57 mmHg Interval -1.69 to 0.56	-1.25 mmHg Interval -2.37 to -0.14	-1.26 mmHg Interval -2.41 to -0.12	-1.97 mmHg Interval -3.11 to -0.84	-3.01 mmHg Interval -4.16 to -1.86	0.92 mmHg Interval -0.22 to 2.06	—

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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 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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=52 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Diastolic Blood Pressure at Week 4	-0.80 mmHg Interval -1.8 to 0.21	-2.47 mmHg Interval -3.44 to -1.49	-3.08 mmHg Interval -4.07 to -2.1	-2.81 mmHg Interval -3.81 to -1.8	-2.10 mmHg Interval -3.11 to -1.09	-0.51 mmHg Interval -1.51 to 0.48	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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 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).

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Diastolic Blood Pressure at Week 8	0.80 mmHg Interval -0.4 to 1.99	-1.40 mmHg Interval -2.56 to -0.24	-0.69 mmHg Interval -1.86 to 0.48	-2.23 mmHg Interval -3.42 to -1.04	-1.20 mmHg Interval -2.4 to 0.01	0.32 mmHg Interval -0.85 to 1.49	—

SECONDARY outcome

Timeframe: Baseline

Population: All randomized participants.

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

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Baseline Fasting Plasma Glucose	165.3 mg/dL Standard Error 5.65	162.5 mg/dL Standard Error 6.75	156.5 mg/dL Standard Error 5.79	163.3 mg/dL Standard Error 6.30	171.3 mg/dL Standard Error 7.69	166.2 mg/dL Standard Error 6.70	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Fasting Plasma Glucose at Week 12	2.76 mg/dL Interval -2.47 to 8.0	-18.23 mg/dL Interval -23.32 to -13.14	-23.06 mg/dL Interval -28.21 to -17.9	-31.47 mg/dL Interval -36.71 to -26.24	-29.26 mg/dL Interval -34.58 to -23.94	-17.29 mg/dL Interval -22.43 to -12.15	—

SECONDARY outcome

Timeframe: Baseline and Week 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=51 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=49 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=50 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=49 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=51 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Fasting Plasma Glucose at Week 2	5.89 mg/dL Interval 0.5 to 11.27	-15.07 mg/dL Interval -20.46 to -9.69	-15.68 mg/dL Interval -21.19 to -10.17	-26.65 mg/dL Interval -32.09 to -21.21	-16.44 mg/dL Interval -21.97 to -10.91	-14.69 mg/dL Interval -20.07 to -9.3	—

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Fasting Plasma Glucose at Week 4	5.17 mg/dL Interval 0.1 to 10.24	-16.91 mg/dL Interval -21.84 to -11.99	-22.77 mg/dL Interval -27.77 to -17.78	-27.95 mg/dL Interval -33.02 to -22.88	-26.62 mg/dL Interval -31.77 to -21.46	-18.00 mg/dL Interval -22.98 to -13.03	—

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=53 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=51 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=50 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=53 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Change From Baseline in Fasting Plasma Glucose at Week 8	3.82 mg/dL Interval -1.06 to 8.69	-18.25 mg/dL Interval -22.99 to -13.51	-24.69 mg/dL Interval -29.49 to -19.89	-31.59 mg/dL Interval -36.46 to -26.71	-30.99 mg/dL Interval -35.94 to -26.04	-18.93 mg/dL Interval -23.71 to -14.15	—

SECONDARY outcome

Timeframe: Week 12

Population: Analysis population excludes participants with missing Week 12 HbA1c measurement.

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

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=50 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=49 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=44 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=47 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=51 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Percentage of Participants Achieving HbA1c <7% at Week 12	15.6 Percentage of participants	44.0 Percentage of participants	42.9 Percentage of participants	38.6 Percentage of participants	36.2 Percentage of participants	43.1 Percentage of participants	—

SECONDARY outcome

Timeframe: Week 12

Population: Analysis population excludes participants with missing Week 12 HbA1c measurement.

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

Outcome measures

Outcome measures
Measure	Placebo n=45 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=50 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=49 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=44 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=47 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=51 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in Participants received open-label metformin during the run-in period.
Percentage of Participants Achieving HbA1C <6.5% at Week 12	6.7 Percentage of participants	12.0 Percentage of participants	20.4 Percentage of participants	13.6 Percentage of participants	14.9 Percentage of participants	25.5 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 98 days

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in n=375 Participants Participants received open-label metformin during the run-in period.
Number of Participants Who Experienced an Advere Event (AE)	29 Participants	31 Participants	30 Participants	29 Participants	28 Participants	30 Participants	82 Participants

SECONDARY outcome

Timeframe: Up to 84 days

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

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 and excludes a temporary discontinuation of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=54 Participants Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 Participants Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 Participants Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 Participants Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 Participants Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 Participants Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in n=375 Participants Participants received open-label metformin during the run-in period.
Number of Participants Who Discontinued Study Medication Due to an AE	1 Participants	1 Participants	3 Participants	2 Participants	1 Participants	1 Participants	3 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Ertugliflozin 1 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Ertugliflozin 5 mg

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Ertugliflozin 10 mg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Ertugliflozin 25 mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Sitagliptin 100 mg

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Metformin Run-in

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=54 participants at risk Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 participants at risk Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 participants at risk Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 participants at risk Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 participants at risk Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 participants at risk Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in n=375 participants at risk Participants received open-label metformin during the run-in period.
Cardiac disorders Acute myocardial infarction	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/375 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Immune system disorders Food allergy	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.27% 1/375 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Infections and infestations Cellulitis	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/375 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Vascular disorders Syncope	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/375 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Cardiac disorders Coronary artery stenosis	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/375 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Cardiac disorders Myocardial infarction	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.27% 1/375 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.

Other adverse events

Other adverse events
Measure	Placebo n=54 participants at risk Placebo for ertugliflozin (1 mg or 5 mg and 25 mg) and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 1 mg n=54 participants at risk Ertugliflozin 1 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 5 mg n=55 participants at risk Ertugliflozin 5 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 10 mg n=55 participants at risk Ertugliflozin 10 mg, placebo for ertugliflozin (25 mg), and placebo to sitagliptin, oral, once daily for 84 days	Ertugliflozin 25 mg n=55 participants at risk Ertugliflozin 25 mg, placebo for ertugliflozin (1 mg or 5 mg), and placebo to sitagliptin, oral, once daily for 84 days	Sitagliptin 100 mg n=55 participants at risk Sitagliptin 100 mg, placebo for ertugliflozin (1 mg or 5 mg and 25 mg), oral, once daily for 84 days	Metformin Run-in n=375 participants at risk Participants received open-label metformin during the run-in period.
Gastrointestinal disorders Diarrhoea	1.9% 1/54 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.7% 2/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.6% 2/55 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	5.5% 3/55 • Number of events 3 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	7.3% 4/55 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.7% 14/375 • Number of events 14 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Infections and infestations Genital infection fungal	1.9% 1/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	5.5% 3/55 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	7.3% 4/55 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.53% 2/375 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Infections and infestations Upper respiratory tract infection	3.7% 2/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.7% 2/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.6% 2/55 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	5.5% 3/55 • Number of events 3 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	5.5% 3/55 • Number of events 3 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.6% 2/55 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.27% 1/375 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Infections and infestations Urinary tract infection	7.4% 4/54 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.7% 2/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	9.1% 5/55 • Number of events 5 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.1% 4/375 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Investigations Blood pressure increased	3.7% 2/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.9% 1/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	5.5% 3/55 • Number of events 3 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/375 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	5.5% 3/55 • Number of events 3 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.3% 5/375 • Number of events 5 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/54 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.7% 2/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	10.9% 6/55 • Number of events 6 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.6% 2/55 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	3.6% 2/55 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.1% 4/375 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Nervous system disorders Dizziness	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/54 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.00% 0/55 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	5.5% 3/55 • Number of events 3 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	0.27% 1/375 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.
Nervous system disorders Headache	3.7% 2/54 • Number of events 2 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.9% 1/54 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	7.3% 4/55 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.8% 1/55 • Number of events 1 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.	1.1% 4/375 • Number of events 4 • Up to 24 weeks (including 10-week run-in period, 12-week treatment period, and 2-week follow-up period). Data presented below include the metformin run-in group (run-in period), 6 treatment groups (treatment period) and no upper limit on the follow-up window for participants who discontinued study drug.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator will provide manuscripts, abstracts, or the full text of any other intended disclosure (poster presentation, invited speaker or guest lecturer presentation, etc.) to the Sponsor at least 30-days before they are submitted for publication or otherwise disclosed. If any patent action is required to protect intellectual property rights, Investigator agrees to delay the disclosure for a period not to exceed an additional 60 days.
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Restriction type: OTHER