Trial Outcomes & Findings for A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006) (NCT NCT01217073)

NCT ID: NCT01217073

Last Updated: 2018-09-10

Results Overview

A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 685 participants
• Primary outcome timeframe: Baseline (Week 0) and Week 12
• Results posted on: 2018-09-10

Participant Flow

Participant milestones

Measure	Omarigliptin 0.25 mg (Base) Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)	Pooled Omarigliptin (Extension) Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)	Placebo/Metformin (Extension) Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
Base Period STARTED	113	115	114	115	114	114	0	0
Base Period COMPLETED	106	110	107	113	99	105	0	0
Base Period NOT COMPLETED	7	5	7	2	15	9	0	0
Extension Period STARTED	0	0	0	0	0	0	405	80
Extension Period COMPLETED	0	0	0	0	0	0	314	60
Extension Period NOT COMPLETED	0	0	0	0	0	0	91	20

Reasons for withdrawal

Measure	Omarigliptin 0.25 mg (Base) Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)	Pooled Omarigliptin (Extension) Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)	Placebo/Metformin (Extension) Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
Base Period Adverse Event	1	0	1	0	4	1	0	0
Base Period Alanine aminotransferase (ALT)/AST	1	0	0	0	0	0	0	0
Base Period Excluded medication	0	0	0	0	1	0	0	0
Base Period Lack of Efficacy	0	0	0	0	0	1	0	0
Base Period Lost to Follow-up	0	0	1	1	3	0	0	0
Base Period Physician Decision	0	0	0	0	1	0	0	0
Base Period Protocol Violation	1	0	0	0	1	2	0	0
Base Period Withdrawal by Subject	4	5	5	1	5	5	0	0
Extension Period Adverse Event	0	0	0	0	0	0	19	5
Extension Period ALT/AST	0	0	0	0	0	0	2	0
Extension Period Contraindication to study medication	0	0	0	0	0	0	1	0
Extension Period Creatinine/eGFR	0	0	0	0	0	0	11	1
Extension Period Death	0	0	0	0	0	0	1	0
Extension Period Excluded medication	0	0	0	0	0	0	2	0
Extension Period Lack of Efficacy	0	0	0	0	0	0	3	0
Extension Period Lost to Follow-up	0	0	0	0	0	0	9	1
Extension Period Non-compliance with study drug	0	0	0	0	0	0	0	1
Extension Period Physician Decision	0	0	0	0	0	0	4	1
Extension Period Protocol Violation	0	0	0	0	0	0	2	1
Extension Period Site discontinued study participation	0	0	0	0	0	0	7	2
Extension Period Withdrawal by Subject	0	0	0	0	0	0	30	8

Baseline Characteristics

A Dose-Range Finding Study in Participants With Type 2 Diabetes (MK-3102-006)

Baseline characteristics by cohort

Measure	Omarigliptin 0.25 mg (Base) n=113 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=115 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=115 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=114 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=114 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)	Total n=685 Participants Total of all reporting groups
Age, Continuous	54.3 Years STANDARD_DEVIATION 8.9 • n=5 Participants	55.7 Years STANDARD_DEVIATION 8.5 • n=7 Participants	55.3 Years STANDARD_DEVIATION 8.5 • n=5 Participants	54.4 Years STANDARD_DEVIATION 10.0 • n=4 Participants	55.1 Years STANDARD_DEVIATION 8.5 • n=21 Participants	55.9 Years STANDARD_DEVIATION 8.4 • n=8 Participants	55.1 Years STANDARD_DEVIATION 8.8 • n=8 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	48 Participants n=7 Participants	49 Participants n=5 Participants	59 Participants n=4 Participants	45 Participants n=21 Participants	49 Participants n=8 Participants	298 Participants n=8 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	67 Participants n=7 Participants	65 Participants n=5 Participants	56 Participants n=4 Participants	69 Participants n=21 Participants	65 Participants n=8 Participants	387 Participants n=8 Participants
Hemoglobin A1c (A1C)	8.1 Percent STANDARD_DEVIATION 0.9 • n=5 Participants	8.0 Percent STANDARD_DEVIATION 0.9 • n=7 Participants	7.9 Percent STANDARD_DEVIATION 0.9 • n=5 Participants	8.0 Percent STANDARD_DEVIATION 0.9 • n=4 Participants	8.1 Percent STANDARD_DEVIATION 1.0 • n=21 Participants	8.1 Percent STANDARD_DEVIATION 0.9 • n=8 Participants	8.1 Percent STANDARD_DEVIATION 0.9 • n=8 Participants
2-hour post meal glucose (2-hr PMG)	229.4 mg/dL STANDARD_DEVIATION 63.7 • n=5 Participants	229.3 mg/dL STANDARD_DEVIATION 64.5 • n=7 Participants	234.7 mg/dL STANDARD_DEVIATION 81.7 • n=5 Participants	231.6 mg/dL STANDARD_DEVIATION 72.3 • n=4 Participants	245.3 mg/dL STANDARD_DEVIATION 82.7 • n=21 Participants	241.4 mg/dL STANDARD_DEVIATION 72.2 • n=8 Participants	235.2 mg/dL STANDARD_DEVIATION 73.2 • n=8 Participants
Fasting plasma glucose (FPG)	170.3 mg/dL STANDARD_DEVIATION 45.3 • n=5 Participants	169.4 mg/dL STANDARD_DEVIATION 42.4 • n=7 Participants	169.0 mg/dL STANDARD_DEVIATION 42.6 • n=5 Participants	166.8 mg/dL STANDARD_DEVIATION 37.6 • n=4 Participants	173.9 mg/dL STANDARD_DEVIATION 47.6 • n=21 Participants	171.9 mg/dL STANDARD_DEVIATION 42.8 • n=8 Participants	170.2 mg/dL STANDARD_DEVIATION 43.0 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=113 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=115 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=115 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=114 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=113 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Change From Baseline in Plasma A1C Levels at Week 12	-0.14 Percent Interval -0.3 to 0.01	-0.36 Percent Interval -0.51 to -0.2	-0.35 Percent Interval -0.5 to -0.19	-0.53 Percent Interval -0.68 to -0.38	-0.57 Percent Interval -0.73 to -0.42	0.14 Percent Interval -0.01 to 0.29

PRIMARY outcome

Timeframe: Up to 16 weeks (including 28 days following the last dose of study drug)

Population: The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=113 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=115 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=115 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=114 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=113 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period	37.2 Percentage of participants	43.5 Percentage of participants	36.8 Percentage of participants	36.5 Percentage of participants	33.3 Percentage of participants	31.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: The all participants as treated population defined as all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received during the study.

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=113 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=115 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=115 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=114 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=113 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period	0.9 Percentage of participants	0 Percentage of participants	0.9 Percentage of participants	0 Percentage of participants	3.5 Percentage of participants	0.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period)

Population: Analysis population defined as all randomized participamts who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=392 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=76 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period	66.8 Percentage of participants	65.8 Percentage of participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 66 weeks (Weeks 12 to 78)

Population: Analysis population defined as all randomized participants who received at least one dose of extension study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received. Participants who received glycemic rescue during the base period were excluded from this analysis population.

An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=392 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=76 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period	3.8 Percentage of participants	5.3 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

Change from baseline was calculated by subtracting the baseline level from the Week 12 level.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=112 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=113 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=114 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=112 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=111 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12	-11.3 mg/dL Interval -21.5 to -1.1	-26.0 mg/dL Interval -35.8 to -16.2	-27.5 mg/dL Interval -37.3 to -17.8	-34.0 mg/dL Interval -43.7 to -24.3	-37.3 mg/dL Interval -47.6 to -27.1	7.5 mg/dL Interval -2.6 to 17.7

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: Full analysis set defined as all randomized participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.

Change from baseline was calculated by subtracting the baseline level from the Week 12 level.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=113 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=115 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=115 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=114 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=113 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12	1.2 mg/dL Interval -4.5 to 7.0	-15.3 mg/dL Interval -20.9 to -9.7	-10.6 mg/dL Interval -16.3 to -4.8	-9.8 mg/dL Interval -15.4 to -4.2	-17.7 mg/dL Interval -23.5 to -11.8	3.7 mg/dL Interval -2.0 to 9.4

SECONDARY outcome

Timeframe: Baseline (Week 0)

Population: All participants who entered the extension period of the study with available A1C baseline data.

A1C levels were measured as a percent at baseline (Week 0) for participants who entered the extension period.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=404 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=80 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Mean Plasma A1C Level at Baseline of the Extension Period	8.0 Percent Standard Deviation 0.9	8.2 Percent Standard Deviation 0.9	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 78

Population: Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.

A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 78 level.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=83 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=91 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=79 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=82 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=70 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=80 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Change From Baseline in Plasma A1C Levels at Week 78	-0.57 Percent Interval -0.89 to -0.25	-0.55 Percent Interval -0.85 to -0.26	-0.30 Percent Interval -0.62 to 0.02	-0.60 Percent Interval -0.93 to -0.28	-0.46 Percent Interval -0.8 to -0.11	-0.88 Percent Interval -1.19 to -0.57

SECONDARY outcome

Timeframe: Baseline (Week 0)

Population: All participants who entered the extension period of the study with available 2h-PMG baseline data.

Plasma 2h-PMG levels were measured at baseline (Week 0) for participants who entered the extension period.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=402 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=79 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Mean 2h-PMG Level at Baseline of the Extension Period	232.8 mg/dL Standard Deviation 69.5	244.5 mg/dL Standard Deviation 70.1	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 78

Population: Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.

Change from baseline was calculated by subtracting the baseline level from the Week 78 level.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=83 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=91 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=79 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=82 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=70 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=79 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Change From Baseline in 2h-PMG at Week 78	-37.0 mg/dL Interval -54.1 to -20.0	-21.3 mg/dL Interval -38.2 to -4.4	-18.0 mg/dL Interval -35.9 to -0.1	-27.6 mg/dL Interval -46.3 to -8.9	-43.2 mg/dL Interval -62.0 to -24.4	-40.3 mg/dL Interval -58.1 to -22.6

SECONDARY outcome

Timeframe: Baseline (Week 0)

Population: All participants who entered the extension period of the study with available FPG baseline data.

Plasma FPG levels were measured at baseline (Week 0) for particiapnts who entered the extension period.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=405 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=80 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Mean FPG Level at Baseline of the Extension Period	169.4 mg/dL Standard Deviation 41.7	172.9 mg/dL Standard Deviation 43.5	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 78

Population: Extension full analysis set population defined as all randomized participants who received at least one dose of extension study treatment, have baseline and at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of extension study treatment.

Change from baseline was calculated by subtracting the baseline level from the Week 78 level.

Outcome measures

Measure	Omarigliptin 0.25 mg (Base) n=83 Participants Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=91 Participants Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=79 Participants Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=82 Participants Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=70 Participants Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=80 Participants Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
Change From Baseline in FPG Levels at Week 78	-7.4 mg/dL Interval -22.4 to 7.6	-11.3 mg/dL Interval -25.0 to 2.5	-2.0 mg/dL Interval -17.1 to 13.1	-10.0 mg/dL Interval -25.0 to 5.0	-0.7 mg/dL Interval -16.7 to 15.3	-19.6 mg/dL Interval -34.1 to -5.1

Adverse Events

Omarigliptin 0.25 mg (Base)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Omarigliptin 1 mg (Base)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Omarigliptin 3 mg (Base)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Omarigliptin 10 mg (Base)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Omarigliptin 25 mg (Base)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo (Base)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Pooled Omarigliptin (Extension)

Serious events: 28 serious events

Other events: 76 other events

Deaths: 0 deaths

Placebo/Metformin (Extension)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Omarigliptin 0.25 mg (Base) n=113 participants at risk Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=115 participants at risk Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 participants at risk Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=115 participants at risk Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=114 participants at risk Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=113 participants at risk Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)	Pooled Omarigliptin (Extension) n=392 participants at risk；n=405 participants at risk Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)	Placebo/Metformin (Extension) n=76 participants at risk；n=80 participants at risk Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
Infections and infestations Influenza	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Pneumonia	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Cardiac disorders Acute coronary syndrome	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Cardiac disorders Acute myocardial infarction	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Cardiac disorders Cardiac failure acute	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Cardiac disorders Cardiogenic shock	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Cardiac disorders Tachyarrhythmia	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Eye disorders Cataract	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Eye disorders Diabetic retinopathy	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Gastrointestinal disorders Pancreatitis	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Hepatobiliary disorders Cholelithiasis	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Chronic sinusitis	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Herpes zoster oticus	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Respiratory tract infection	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	1.2% 1/80 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.49% 2/405 • Number of events 2 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Nervous system disorders Cerebral infarction	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Nervous system disorders Cerebrovascular accident	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.74% 3/405 • Number of events 3 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Nervous system disorders Diabetic neuropathy	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Nervous system disorders Loss of consciousness	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	1.2% 1/80 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.25% 1/405 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Vascular disorders Deep vein thrombosis	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	1.2% 1/80 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Appendicitis	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.88% 1/114 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Post procedural infection	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.87% 1/115 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Pyelonephritis acute	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.88% 1/114 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Wound infection	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.87% 1/115 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.87% 1/115 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.88% 1/114 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/405 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/80 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.

Other adverse events

Measure	Omarigliptin 0.25 mg (Base) n=113 participants at risk Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)	Omarigliptin 1 mg (Base) n=115 participants at risk Omarigliptin 1 mg administered once weekly for 12 weeks (base period)	Omarigliptin 3 mg (Base) n=114 participants at risk Omarigliptin 3 mg administered once weekly for 12 weeks (base period)	Omarigliptin 10 mg (Base) n=115 participants at risk Omarigliptin 10 mg administered once weekly for 12 weeks (base period)	Omarigliptin 25 mg (Base) n=114 participants at risk Omarigliptin 25 mg administered once weekly for 12 weeks (base period)	Placebo (Base) n=113 participants at risk Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)	Pooled Omarigliptin (Extension) n=392 participants at risk；n=405 participants at risk Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)	Placebo/Metformin (Extension) n=76 participants at risk；n=80 participants at risk Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
Infections and infestations Influenza	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	1.7% 2/115 • Number of events 2 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.87% 1/115 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.88% 1/114 • Number of events 1 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/113 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	3.3% 13/392 • Number of events 18 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	5.3% 4/76 • Number of events 4 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Infections and infestations Nasopharyngitis	3.5% 4/113 • Number of events 4 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	4.3% 5/115 • Number of events 5 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	3.5% 4/114 • Number of events 4 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	3.5% 4/115 • Number of events 4 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	5.3% 6/114 • Number of events 6 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	3.5% 4/113 • Number of events 4 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	11.5% 45/392 • Number of events 52 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	5.3% 4/76 • Number of events 5 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.
Metabolism and nutrition disorders Hyperglycaemia	1.8% 2/113 • Number of events 3 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/115 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	0.00% 0/114 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	1.8% 2/113 • Number of events 2 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	5.9% 23/392 • Number of events 49 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.	3.9% 3/76 • Number of events 3 • Up to 82 weeks (including 28 days following the last dose of study drug) All participants as treated population. Serious AEs and non-serious AEs (NSAEs) include and exclude data after glycemic rescue, respectively. During the base period, 17 participants initiated glycemic rescue and were not included in the total number at risk for NSAEs during the extension period. MedDRA 15.1 was used for extension arms only.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
• Publication restrictions are in place

Restriction type: OTHER