Trial Outcomes & Findings for A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007). (NCT NCT02033889)

NCT ID: NCT02033889

Last Updated: 2018-09-10

Results Overview

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

621 participants

Primary outcome timeframe

Baseline and Week 26

Results posted on

2018-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo/Glimepiride Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Overall Study STARTED	209	207	205
Overall Study COMPLETED	175	187	180
Overall Study NOT COMPLETED	34	20	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Glimepiride Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Overall Study Adverse Event	3	1	3
Overall Study Death	3	1	2
Overall Study Excluded Medication	1	1	0
Overall Study Lost to Follow-up	8	5	6
Overall Study Non-Compliance With Study Drug	1	0	0
Overall Study Physician Decision	0	1	1
Overall Study Participant moved	0	1	0
Overall Study Withdrawal by Subject	18	10	13

Baseline Characteristics

All randomized and treated participants

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)	-0.03 Percent A1C Interval -0.15 to 0.1	-0.73 Percent A1C Interval -0.85 to -0.61	-0.91 Percent A1C Interval -1.03 to -0.78

PRIMARY outcome

Timeframe: Up to Week 106

Population: All participants who received at least one dose of investigational product.

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)	77.5 Percentage of Participants	70.5 Percentage of Participants	75.6 Percentage of Participants

PRIMARY outcome

Timeframe: Up to Week 104

Population: All participants who received at least one dose of investigational product.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)	2.4 Percentage of Participants	3.4 Percentage of Participants	3.9 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)	-0.85 mg/dL Interval -5.93 to 4.23	-27.54 mg/dL Interval -32.36 to -22.73	-39.10 mg/dL Interval -43.96 to -34.23

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.

The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)	-1.33 Kilograms Interval -1.74 to -0.92	-3.01 Kilograms Interval -3.4 to -2.62	-2.93 Kilograms Interval -3.33 to -2.53

SECONDARY outcome

Timeframe: Week 26

Population: All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)	15.8 Percentage of Participants	35.3 Percentage of Participants	40.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.

This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=204 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)	-0.70 mmHg Interval -2.46 to 1.06	-4.38 mmHg Interval -6.01 to -2.75	-5.20 mmHg Interval -6.87 to -3.54

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.

This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=204 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)	0.23 mmHg Interval -0.85 to 1.31	-1.59 mmHg Interval -2.59 to -0.59	-2.19 mmHg Interval -3.21 to -1.17

SECONDARY outcome

Timeframe: Week 26

Population: All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)	2.9 Percentage of Participants	8.7 Percentage of Participants	12.2 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Week 26

Population: All participants who received at least one dose of investigational product.

Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 26	17.7 Percentage of Participants	2.9 Percentage of Participants	1.5 Percentage of Participants

SECONDARY outcome

Timeframe: Week 26

Population: All participants who received at least one dose of investigational product and received glycemic rescue through Week 26.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=36 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=6 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=3 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Time to Glycemic Rescue Therapy at Week 26	105 Days Interval 15.0 to 183.0	112 Days Interval 23.0 to 151.0	139 Days Interval 127.0 to 145.0

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 52 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=140 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=179 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=173 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in A1C at Week 52 (Excluding Rescue Approach)	-0.68 Percent A1C Standard Deviation 0.99	-0.72 Percent A1C Standard Deviation 0.95	-0.96 Percent A1C Standard Deviation 0.88

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=136 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=173 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=173 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Fasting Plasma Glucose at Week 52 (Excluding Rescue Therapy)	-12.0 mg/dL Standard Deviation 40.0	-22.4 mg/dL Standard Deviation 39.3	-35.2 mg/dL Standard Deviation 40.7

SECONDARY outcome

Timeframe: Week 52

Population: All randomized participants who received at least one dose of investigational product. Any participant without post-baseline data at Week 52 was assumed to be "not at goal", where goal was A1C \<7%, for the calculation of the percentages.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach)	30.6 Percentage of Participants	34.8 Percentage of Participants	36.6 Percentage of Participants

SECONDARY outcome

Timeframe: Week 52

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 52 (Excluding Rescue Approach)	11.0 Percentage of Participants	10.6 Percentage of Participants	14.6 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: All participants who received at least one dose of investigational product.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52	17.2 Percentage of Participants Interval 12.37 to 23.04	4.3 Percentage of Participants Interval 2.01 to 8.09	1.5 Percentage of Participants Interval 0.3 to 4.22

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

The change in body weight from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=142 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=181 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=178 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Body Weight at Week 52 (Excluding Rescue Approach)	0.07 Kilograms Standard Deviation 2.85	-3.23 Kilograms Standard Deviation 3.68	-3.35 Kilograms Standard Deviation 3.27

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

This change from baseline reflects the Week 52 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=134 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=177 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=173 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Sitting Systolic Blood Pressure at Week 52 (Excluding Rescue Approach)	0.65 mmHg Standard Deviation 13.38	-2.63 mmHg Standard Deviation 14.40	-4.28 mmHg Standard Deviation 13.28

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

This change from baseline reflects the Week 52 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=134 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=177 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=173 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 (Excluding Rescue Approach)	0.38 mmHg Standard Deviation 8.16	-1.40 mmHg Standard Deviation 9.60	-1.19 mmHg Standard Deviation 7.74

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 104 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=109 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=147 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=142 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in A1C at Week 104 (Excluding Rescue Approach)	-0.58 Percent A1C Standard Deviation 0.93	-0.60 Percent A1C Standard Deviation 0.97	-0.89 Percent A1C Standard Deviation 0.90

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 104 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 104 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=104 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=143 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=144 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Fasting Plasma Glucose at Week 104 (Excluding Rescue Approach)	-10.9 mg/dL Standard Deviation 44.3	-18.2 mg/dL Standard Deviation 43.5	-28.2 mg/dL Standard Deviation 44.9

SECONDARY outcome

Timeframe: Week 104

Population: All randomized participants who received at least one dose of investigational product. Any participant without post-baseline data at Week 104 was assumed to be "not at goal", where goal was A1C \<7%, for the calculation of the percentages.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 104 (Excluding Rescue Approach)	19.1 Percentage of Participants	24.6 Percentage of Participants	33.7 Percentage of Participants

SECONDARY outcome

Timeframe: Week 104

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 104 (Excluding Rescue Approach)	7.2 Percentage of Participants	10.6 Percentage of Participants	12.2 Percentage of Participants

SECONDARY outcome

Timeframe: Up to Week 104

Population: All participants who received at least one dose of investigational product.

Per protocol participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 104	24.4 Percentage of participants Interval 18.74 to 30.8	11.1 Percentage of participants Interval 7.18 to 16.2	10.7 Percentage of participants Interval 6.85 to 15.8

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

The change in body weight from baseline reflects the Week 104 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=112 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=148 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=145 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Body Weight at Week 104 (Excluding Rescue Approach)	-0.18 Kilograms Standard Deviation 3.38	-3.77 Kilograms Standard Deviation 4.29	-3.63 Kilograms Standard Deviation 3.86

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

This change from baseline reflects the Week 104 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=104 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=145 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=142 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Sitting Systolic Blood Pressure at Week 104 (Excluding Rescue Approach)	0.05 mmHg Standard Deviation 13.76	-3.61 mmHg Standard Deviation 12.78	-3.13 mmHg Standard Deviation 14.11

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

This change from baseline reflects the Week 104 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=104 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=145 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=142 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Change From Baseline in Sitting Diastolic Blood Pressure at Week 104 (Excluding Rescue Approach)	-0.46 mmHg Standard Deviation 8.77	-2.36 mmHg Standard Deviation 9.23	-1.52 mmHg Standard Deviation 8.61

SECONDARY outcome

Timeframe: Pre-dose and/or 60 minutes post-dose on Weeks 6, 12, 18, and 30

Population: All subjects as treated (including those with all concentrations below the lower limit of quantification) were included in the calculation of the summary statistics. Numbers of participants with non-missing concentrations at the respective time points are displayed.

Pharmacokinetic samples were collected at approximately 24 hours following the prior day's dose and before administration of the current day's dose. The lower limit of quantitation (LLOQ) was 0.500 mg/mL. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach) Week 6:Pre-dose	NA ng/mL Standard Deviation NA Below the lower limit of quantification	14.89 ng/mL Standard Deviation 28.11	38.38 ng/mL Standard Deviation 74.83
Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach) Week 12:Pre-dose	NA ng/mL Standard Deviation NA Below the lower limit of quantification	12.34 ng/mL Standard Deviation 26.07	29.23 ng/mL Standard Deviation 55.63
Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach) Week 12:60 mins post-dose	NA ng/mL Standard Deviation NA Below the lower limit of quantification	74.84 ng/mL Standard Deviation 51.58	228.13 ng/mL Standard Deviation 139.14
Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach) Week 18:Pre-dose	0.01 ng/mL Standard Deviation 0.10	9.91 ng/mL Standard Deviation 21.18	24.46 ng/mL Standard Deviation 39.97
Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach) Week 18:60 mins post-dose	0.01 ng/mL Standard Deviation 0.09	74.39 ng/mL Standard Deviation 49.77	214.96 ng/mL Standard Deviation 147.36
Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach) Week 30:Pre-dose	0.15 ng/mL Standard Deviation 1.07	12.66 ng/mL Standard Deviation 25.50	30.55 ng/mL Standard Deviation 60.33

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=200 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=189 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)	0.22 Percentage change Interval -0.2 to 0.65	-0.01 Percentage change Interval -0.42 to 0.41	0.12 Percentage change Interval -0.31 to 0.55

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=200 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=190 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)	-0.40 Percent change Interval -0.89 to 0.09	-0.10 Percent change Interval -0.57 to 0.38	0.30 Percent change Interval -0.19 to 0.79

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the total hip was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=200 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=190 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)	-0.63 Percent change Interval -0.92 to -0.34	-0.55 Percent change Interval -0.83 to -0.27	-0.36 Percent change Interval -0.65 to -0.07

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the distal forearm was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=190 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=200 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=189 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)	0.06 Percent change Interval -0.35 to 0.47	-0.15 Percent change Interval -0.55 to 0.24	-0.13 Percent change Interval -0.53 to 0.28

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 26.

CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=185 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=179 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=180 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX) at Week 26 (Excluding Bone Rescue Approach)	10.8 Percent change Standard Deviation 106.6	51.9 Percent change Standard Deviation 121.9	80.2 Percent change Standard Deviation 149.7

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 26.

P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=186 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=183 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=183 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP) at Week 26 (Excluding Bone Rescue Approach)	0.5 Percent change Standard Deviation 11.7	0.8 Percent change Standard Deviation 12.1	0.5 Percent change Standard Deviation 15.0

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 26.

PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=186 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=182 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=184 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker Parathyroid Hormone (PTH) at Week 26 (Excluding Bone Rescue Approach)	-0.98 Percent change Standard Deviation 6.71	0.28 Percent change Standard Deviation 7.52	0.14 Percent change Standard Deviation 7.53

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=202 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=189 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)	-0.10 Percent change Interval -0.6 to 0.4	-0.28 Percent change Interval -0.77 to 0.2	0.07 Percent change Interval -0.43 to 0.57

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=202 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=190 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)	-0.69 Percent change Interval -1.25 to -0.14	-0.49 Percent change Interval -1.04 to 0.06	-0.44 Percent change Interval -1.06 to 0.17

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the total hip was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=202 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=190 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)	-0.82 Percent change Interval -1.19 to -0.46	-1.04 Percent change Interval -1.41 to -0.67	-1.32 Percent change Interval -1.69 to -0.94

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the distal forearm was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=190 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=200 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=189 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)	-0.44 Percent change Interval -0.95 to 0.06	-0.59 Percent change Interval -1.04 to 0.14	-0.39 Percent change Interval -0.9 to 0.12

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=171 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=178 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=171 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker CTX at Week 52 (Excluding Bone Rescue Approach)	15.54 Percent change Standard Deviation 43.34	34.36 Percent change Standard Deviation 52.74	41.57 Percent change Standard Deviation 50.69

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=171 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=179 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=173 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (Excluding Bone Rescue Approach)	24.50 Percent Change Standard Deviation 120.29	8.41 Percent Change Standard Deviation 30.95	19.79 Percent Change Standard Deviation 79.57

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=171 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=177 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=175 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker PTH at Week 52 (Excluding Bone Rescue Approach)	8.11 Percent Change Standard Deviation 52.05	11.09 Percent Change Standard Deviation 41.80	2.48 Percent Change Standard Deviation 36.57

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=202 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=189 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)	0.09 Percent change Interval -0.47 to 0.66	-0.19 Percent change Interval -0.72 to 0.35	-0.13 Percent change Interval -0.68 to 0.42

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=202 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=190 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)	-1.23 Percent change Interval -1.86 to -0.61	-1.11 Percent change Interval -1.74 to -0.49	-0.96 Percent change Interval -1.67 to -0.26

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the total hip was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=191 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=202 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=190 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)	-1.18 Percent change Interval -1.63 to -0.73	-1.72 Percent change Interval -2.19 to -1.25	-2.02 Percent change Interval -2.51 to -1.53

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.

BMD at the distal forearm was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=190 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=200 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=189 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From BMD at Week 104 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)	-0.58 Percent change Interval -1.13 to -0.03	-0.40 Percent change Interval -0.87 to 0.06	-0.64 Percent change Interval -1.19 to -0.09

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=149 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=160 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=159 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker CTX at Week 104 (Excluding Bone Rescue Approach)	19.29 Percent change Standard Deviation 71.73	26.94 Percent change Standard Deviation 58.44	32.53 Percent change Standard Deviation 59.29

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=149 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=162 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=162 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker P1NP at Week 104 (Excluding Bone Rescue Approach)	19.38 Percent change Standard Deviation 93.02	10.11 Percent change Standard Deviation 39.14	24.21 Percent change Standard Deviation 83.23

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.

Outcome measures

Outcome measures
Measure	Placebo/Glimepiride n=148 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=158 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=161 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Percent Change From Baseline in Bone Biomarker PTH at Week 104 (Excluding Bone Rescue Approach)	10.12 Percent change Standard Deviation 60.13	8.16 Percent change Standard Deviation 40.97	5.46 Percent change Standard Deviation 38.53

Adverse Events

Placebo/Glimepiride

Serious events: 22 serious events

Other events: 103 other events

Deaths: 3 deaths

Ertugliflozin 5 mg

Serious events: 20 serious events

Other events: 79 other events

Deaths: 1 deaths

Ertugliflozin 15 mg

Serious events: 20 serious events

Other events: 100 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo/Glimepiride n=209 participants at risk Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 participants at risk Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 participants at risk Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.
Infections and infestations Influenza	5.7% 12/209 • Number of events 13 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	5.3% 11/207 • Number of events 13 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	4.9% 10/205 • Number of events 13 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Infections and infestations Upper respiratory tract infection	15.8% 33/209 • Number of events 44 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	11.1% 23/207 • Number of events 30 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	10.2% 21/205 • Number of events 22 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Infections and infestations Urinary tract infection	6.2% 13/209 • Number of events 18 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	2.9% 6/207 • Number of events 9 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	8.3% 17/205 • Number of events 22 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Infections and infestations Viral upper respiratory tract infection	10.0% 21/209 • Number of events 27 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	5.8% 12/207 • Number of events 16 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	4.4% 9/205 • Number of events 11 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Investigations Weight decreased	1.4% 3/209 • Number of events 3 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	4.3% 9/207 • Number of events 9 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	7.3% 15/205 • Number of events 15 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Metabolism and nutrition disorders Hypoglycaemia	20.6% 43/209 • Number of events 213 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	6.8% 14/207 • Number of events 119 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	8.8% 18/205 • Number of events 66 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 7/209 • Number of events 7 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	3.4% 7/207 • Number of events 9 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	5.4% 11/205 • Number of events 12 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Musculoskeletal and connective tissue disorders Back pain	4.8% 10/209 • Number of events 10 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	4.3% 9/207 • Number of events 10 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	9.8% 20/205 • Number of events 20 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Nervous system disorders Headache	4.8% 10/209 • Number of events 15 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	6.8% 14/207 • Number of events 18 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	5.4% 11/205 • Number of events 15 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 11/209 • Number of events 13 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	3.9% 8/207 • Number of events 8 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.	3.9% 8/205 • Number of events 8 • Up to 106 weeks Participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or insulin glargine according to Investigator judgment. The analysis population was all participants who received at least one dose of investigational product. Adverse events were reported for the all post-randomization follow-up period.

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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo/Glimepiride n=209 Participants Placebo to ertugliflozin, orally once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received blinded glimepiride. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 5 mg n=207 Participants Ertugliflozin 5 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Ertugliflozin 15 mg n=205 Participants Ertugliflozin 15 mg orally, once daily from Day 1 to Week 104. Up to 26 weeks, participants meeting glycemic rescue criteria were rescued with open-label glimepiride, and if they met rescue criteria again, and they were on maximal tolerated doses of glimepiride, they received basal insulin. After Week 26, non-rescued participants who had a fasting finger-stick glucose ≥110 mg/dL received glimepiride/placebo. If a participant met glycemic rescue criteria after 26 weeks, and they were on maximal tolerated dose of glimepiride, then rescue with basal insulin was initiated.	Total n=621 Participants Total of all reporting groups
Age, Continuous	56.5 Years STANDARD_DEVIATION 8.7 • n=209 Participants • All randomized and treated participants	56.6 Years STANDARD_DEVIATION 8.2 • n=207 Participants • All randomized and treated participants	56.9 Years STANDARD_DEVIATION 9.4 • n=205 Participants • All randomized and treated participants	56.6 Years STANDARD_DEVIATION 8.8 • n=621 Participants • All randomized and treated participants
Sex: Female, Male Female	111 Participants n=209 Participants • All randomized and treated participants	110 Participants n=207 Participants • All randomized and treated participants	112 Participants n=205 Participants • All randomized and treated participants	333 Participants n=621 Participants • All randomized and treated participants
Sex: Female, Male Male	98 Participants n=209 Participants • All randomized and treated participants	97 Participants n=207 Participants • All randomized and treated participants	93 Participants n=205 Participants • All randomized and treated participants	288 Participants n=621 Participants • All randomized and treated participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=209 Participants • All randomized and treated participants	0 Participants n=207 Participants • All randomized and treated participants	0 Participants n=205 Participants • All randomized and treated participants	0 Participants n=621 Participants • All randomized and treated participants
Race (NIH/OMB) Asian	31 Participants n=209 Participants • All randomized and treated participants	34 Participants n=207 Participants • All randomized and treated participants	35 Participants n=205 Participants • All randomized and treated participants	100 Participants n=621 Participants • All randomized and treated participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=209 Participants • All randomized and treated participants	0 Participants n=207 Participants • All randomized and treated participants	0 Participants n=205 Participants • All randomized and treated participants	0 Participants n=621 Participants • All randomized and treated participants
Race (NIH/OMB) Black or African American	19 Participants n=209 Participants • All randomized and treated participants	22 Participants n=207 Participants • All randomized and treated participants	23 Participants n=205 Participants • All randomized and treated participants	64 Participants n=621 Participants • All randomized and treated participants
Race (NIH/OMB) White	144 Participants n=209 Participants • All randomized and treated participants	134 Participants n=207 Participants • All randomized and treated participants	133 Participants n=205 Participants • All randomized and treated participants	411 Participants n=621 Participants • All randomized and treated participants
Race (NIH/OMB) More than one race	15 Participants n=209 Participants • All randomized and treated participants	17 Participants n=207 Participants • All randomized and treated participants	14 Participants n=205 Participants • All randomized and treated participants	46 Participants n=621 Participants • All randomized and treated participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=209 Participants • All randomized and treated participants	0 Participants n=207 Participants • All randomized and treated participants	0 Participants n=205 Participants • All randomized and treated participants	0 Participants n=621 Participants • All randomized and treated participants
Baseline Hemoglobin A1C (A1C)	8.17 Percentage A1C STANDARD_DEVIATION 0.90 • n=207 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline A1C.	8.06 Percentage A1C STANDARD_DEVIATION 0.89 • n=205 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline A1C.	8.13 Percentage A1C STANDARD_DEVIATION 0.93 • n=202 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline A1C.	8.12 Percentage A1C STANDARD_DEVIATION 0.90 • n=614 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline A1C.
Fasting Plasma Glucose (FPG)	169.1 mg/dL STANDARD_DEVIATION 41.7 • n=202 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline FPG.	168.1 mg/dL STANDARD_DEVIATION 45.5 • n=199 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline FPG.	167.5 mg/dL STANDARD_DEVIATION 44.4 • n=203 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline FPG.	168.3 mg/dL STANDARD_DEVIATION 43.8 • n=604 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline FPG.
Body Weight	84.5 Kilograms STANDARD_DEVIATION 17.1 • n=209 Participants • All randomized and treated participants who had a baseline Body Weight.	84.8 Kilograms STANDARD_DEVIATION 17.2 • n=207 Participants • All randomized and treated participants who had a baseline Body Weight.	85.3 Kilograms STANDARD_DEVIATION 16.5 • n=205 Participants • All randomized and treated participants who had a baseline Body Weight.	84.9 Kilograms STANDARD_DEVIATION 16.9 • n=621 Participants • All randomized and treated participants who had a baseline Body Weight.
Sitting Systolic Blood Pressure (SBP)	129.30 mmHg STANDARD_DEVIATION 15.43 • n=201 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline SBP.	130.48 mmHg STANDARD_DEVIATION 13.77 • n=201 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline SBP.	130.37 mmHg STANDARD_DEVIATION 12.00 • n=198 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline SBP.	130.05 mmHg STANDARD_DEVIATION 13.80 • n=600 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline SBP.
Diastolic Blood Pressure (DBP)	77.45 mmHg STANDARD_DEVIATION 7.55 • n=201 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline DBP.	78.45 mmHg STANDARD_DEVIATION 8.32 • n=201 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline DBP.	78.08 mmHg STANDARD_DEVIATION 7.45 • n=198 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline DBP.	77.99 mmHg STANDARD_DEVIATION 7.78 • n=600 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline DBP.
Bone Mineral Density (BMD) as Measured by Dual Energy X-Ray Absorptiometry (DXA) of the Femoral Neck	0.92 g/cm^2 STANDARD_DEVIATION 0.17 • n=209 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the femoral neck.	0.92 g/cm^2 STANDARD_DEVIATION 0.16 • n=207 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the femoral neck.	0.89 g/cm^2 STANDARD_DEVIATION 0.15 • n=205 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the femoral neck.	0.91 g/cm^2 STANDARD_DEVIATION 0.16 • n=621 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the femoral neck.
BMD as Measured by DXA of the Lumbar Spine (L1-L4)	1.15 g/cm^2 STANDARD_DEVIATION 0.18 • n=209 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the lumbar spine (L1-L4).	1.13 g/cm^2 STANDARD_DEVIATION 0.18 • n=207 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the lumbar spine (L1-L4).	1.10 g/cm^2 STANDARD_DEVIATION 0.17 • n=204 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the lumbar spine (L1-L4).	1.13 g/cm^2 STANDARD_DEVIATION 0.18 • n=620 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the lumbar spine (L1-L4).
BMD as Measured by DXA of the Total hip	1.06 g/cm^2 STANDARD_DEVIATION 0.15 • n=209 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the total hip.	1.07 g/cm^2 STANDARD_DEVIATION 0.15 • n=207 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the total hip.	1.04 g/cm^2 STANDARD_DEVIATION 0.14 • n=205 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the total hip.	1.06 g/cm^2 STANDARD_DEVIATION 0.15 • n=621 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the total hip.
BMD as Measured by DXA at the Distal Forearm	0.81 g/cm^2 STANDARD_DEVIATION 0.14 • n=209 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the distal forearm.	0.81 g/cm^2 STANDARD_DEVIATION 0.14 • n=205 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the distal forearm.	0.79 g/cm^2 STANDARD_DEVIATION 0.13 • n=205 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the distal forearm.	0.80 g/cm^2 STANDARD_DEVIATION 0.14 • n=619 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline BMD of the distal forearm.
Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX)	268.3 ng/L STANDARD_DEVIATION 132.9 • n=200 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline CTX.	266.9 ng/L STANDARD_DEVIATION 129.9 • n=196 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline CTX.	273.0 ng/L STANDARD_DEVIATION 135.2 • n=195 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline CTX.	269.4 ng/L STANDARD_DEVIATION 132.5 • n=591 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline CTX.
Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP)	32.0 microgm/L STANDARD_DEVIATION 15.0 • n=200 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline P1NP.	32.8 microgm/L STANDARD_DEVIATION 14.5 • n=198 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline P1NP.	31.6 microgm/L STANDARD_DEVIATION 16.5 • n=198 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline P1NP.	32.1 microgm/L STANDARD_DEVIATION 15.3 • n=596 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline P1NP.
Bone Biomarker Parathyroid Hormone (PTH)	19.29 ng/L STANDARD_DEVIATION 8.17 • n=202 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline PTH.	19.52 ng/L STANDARD_DEVIATION 6.91 • n=194 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline PTH.	19.97 ng/L STANDARD_DEVIATION 7.73 • n=200 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline PTH.	19.59 ng/L STANDARD_DEVIATION 7.62 • n=596 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline PTH.
Menopausal Status Male	98 Participants n=209 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	97 Participants n=207 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	93 Participants n=205 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	288 Participants n=621 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.
Menopausal Status Premenopausal Women	16 Participants n=209 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	17 Participants n=207 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	16 Participants n=205 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	49 Participants n=621 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.
Menopausal Status Perimenopausal or <3 yrs. postmen.	9 Participants n=209 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	10 Participants n=207 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	11 Participants n=205 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	30 Participants n=621 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.
Menopausal Status Women ≥3 years postmenopausal	86 Participants n=209 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	83 Participants n=207 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	85 Participants n=205 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.	254 Participants n=621 Participants • All randomized participants who have received at least one dose of investigational product and have menopausal status baseline information.
Estimated Glomerular Filtration Rate (eGFR)	91.6 mL/min/1.73 m^2 STANDARD_DEVIATION 19.8 • n=209 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline eGFR.	88.9 mL/min/1.73 m^2 STANDARD_DEVIATION 17.5 • n=207 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline eGFR.	91.1 mL/min/1.73 m^2 STANDARD_DEVIATION 20.6 • n=205 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline eGFR.	90.5 mL/min/1.73 m^2 STANDARD_DEVIATION 19.3 • n=621 Participants • All randomized participants who have received at least one dose of investigational product and have a measurement of baseline eGFR.