Trial Outcomes & Findings for Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059) (NCT NCT04029480)

Last Updated: 2025-10-31

Results Overview

Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the A1C change from baseline (i.e., % A1C at Week 24 minus % A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The Bayesian mean change from baseline for each combined ertugliflozin and placebo are reported. Per protocol, the ertugliflozin arms are combined for this analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

166 participants

Primary outcome timeframe

Baseline and Week 24

Results posted on

2025-10-31

Participant Flow

Participants were screened up to 4 weeks before dosing. Participants were confirmed at screening to have T2DM for ≥2 years, conform to T2DM protocol specific requirements and be on stable metformin with or without insulin. The first randomization was stratified according to the following factors collected at screening: age (10 to 14 years of age/15 to 17 years) and insulin use (yes/no). Treatment randomization at Week 12 was stratified according to insulin use (yes/no) at screening.

Participant milestones

Participant milestones
Measure	5 mg Ertugliflozin Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	5 mg/5 mg Ertugliflozin Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	5 mg/15 mg Ertugliflozin Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.	Placebo Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Overall Study STARTED	63	22	26	55
Overall Study Re-Randomized	0	22	26	0
Overall Study COMPLETED	61	22	23	53
Overall Study NOT COMPLETED	2	0	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	5 mg Ertugliflozin Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	5 mg/5 mg Ertugliflozin Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	5 mg/15 mg Ertugliflozin Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.	Placebo Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Overall Study Physician Decision	0	0	2	1
Overall Study Withdrawal by Subject	2	0	1	1

Baseline Characteristics

Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5 mg Ertugliflozin n=63 Participants Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	5 mg/5 mg Ertugliflozin n=22 Participants Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	5 mg/15 mg Ertugliflozin n=26 Participants Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were up-titrated to 15 mg ERTU and placebo to 5 mg ERTU from WK12 to WK54.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.	Total n=166 Participants Total of all reporting groups
Age, Continuous	14.4 years STANDARD_DEVIATION 2.0 • n=5 Participants	14.6 years STANDARD_DEVIATION 2.0 • n=7 Participants	15.6 years STANDARD_DEVIATION 1.8 • n=5 Participants	15.1 years STANDARD_DEVIATION 1.7 • n=4 Participants	14.8 years STANDARD_DEVIATION 1.9 • n=21 Participants
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized Children (2-11 years)	6 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Age, Customized Adolescents (12-17 years)	56 Participants n=5 Participants	20 Participants n=7 Participants	24 Participants n=5 Participants	52 Participants n=4 Participants	152 Participants n=21 Participants
Age, Customized Adults (18-64 years)	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants	30 Participants n=4 Participants	98 Participants n=21 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	12 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants	68 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	22 Participants n=4 Participants	72 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	33 Participants n=4 Participants	93 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	31 Participants n=4 Participants	99 Participants n=21 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Baseline A1C	7.6 A1C Percentage STANDARD_DEVIATION 1.0 • n=5 Participants	8.5 A1C Percentage STANDARD_DEVIATION 1.1 • n=7 Participants	8.8 A1C Percentage STANDARD_DEVIATION 0.9 • n=5 Participants	8.0 A1C Percentage STANDARD_DEVIATION 1.0 • n=4 Participants	8.0 A1C Percentage STANDARD_DEVIATION 1.1 • n=21 Participants
Insulin Use at Screening Yes	18 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	24 Participants n=4 Participants	73 Participants n=21 Participants
Insulin Use at Screening No	45 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	31 Participants n=4 Participants	93 Participants n=21 Participants
Age at Screening 10 to 14 years of age	27 Years n=5 Participants	11 Years n=7 Participants	8 Years n=5 Participants	23 Years n=4 Participants	69 Years n=21 Participants
Age at Screening 15 to 17 years of age	36 Years n=5 Participants	11 Years n=7 Participants	18 Years n=5 Participants	32 Years n=4 Participants	97 Years n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: This analysis includes all participants who received at least 1 dose of study treatment and excludes data following initiation of rescue therapy as well as data collected more than 5 days after the discontinuation of study medication.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)	-0.55 A1C Percentage Interval -0.82 to -0.28	0.12 A1C Percentage Interval -0.23 to 0.47

PRIMARY outcome

Timeframe: Up to Week 24

Population: The analysis population includes all randomized participants who received at least one dose of study treatment.

An adverse event -- Select --is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Number of Participants Who Experienced an Adverse Event (AE) Up to Week 24	59 Participants	33 Participants

PRIMARY outcome

Timeframe: Up to Week 54

Population: The analysis population includes all randomized participants who received at least one dose of study treatment.

An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Per protocol, the ertugliflozin arms are combined for this analysis.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Number of Participants Who Experienced an AE Up to Week 54	71 Participants	42 Participants

PRIMARY outcome

Timeframe: Up to Week 24

Population: The analysis population includes all randomized participants who received at least one dose of study treatment up.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 24	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 54

Population: The analysis population includes all randomized participants who received at least one dose of study treatment up.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Number of Participants Who Discontinued Study Treatment Due to an AE Up to Week 54	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: This analysis includes all participants who were randomized to ertugliflozin and either did not meet the re-randomization criteria at Week 12 or were re-randomized to ertugliflozin 15 mg, took at least 1 dose of study treatment, and includes all data following initiation of rescue therapy as well as data collected after the discontinuation of study medication.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=89 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Change From Baseline in Hemoglobin A1C at Week 24 (Dose-optimized Ertugliflozin Versus Placebo)	-0.42 A1C Percentage Interval -0.76 to -0.08	0.25 A1C Percentage Interval -0.22 to 0.72

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: This analysis includes all participants randomized to ertugliflozin and either did not meet the re-randomization criteria at Week 12 or were re-randomized to 5 mg ertugliflozin, and all data following initiation of rescue therapy as well as data collected after the discontinuation of study medication.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=85 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Change From Baseline in Hemoglobin A1C at Week 24 (5 mg Ertugliflozin Versus Placebo)	-0.54 A1C Percentage Interval -0.86 to -0.22	0.32 A1C Percentage Interval -0.11 to 0.76

SECONDARY outcome

Timeframe: Baseline and Week 24

Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-20.8 mg/dL Interval -30.8 to -10.8	8.2 mg/dL Interval -5.4 to 21.7

SECONDARY outcome

Timeframe: Baseline and Week 54

Hemoglobin A1C is a measure of the percentage of glycated HbA1C in the blood. Participant whole blood samples were collected at baseline and Week 54 to determine the A1C change from baseline (i.e., A1C at Week 54 minus A1C at baseline). A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Change From Baseline in Hemoglobin A1C at Week 54	-0.22 AIC Percentage Interval -0.59 to 0.16	0.81 AIC Percentage Interval 0.24 to 1.38

SECONDARY outcome

Timeframe: Baseline and Week 54

Blood glucose is measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline). A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. Per protocol, the ertugliflozin arms were combined for this analysis.

Outcome measures

Outcome measures
Measure	Combined Ertugliflozin n=111 Participants Participants who received at least 1 dose of ertugliflozin.	Placebo n=55 Participants Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Change From Baseline in FPG at Week 54	-12.1 mg/dL Interval -23.7 to -0.5	21.0 mg/dL Interval 3.6 to 38.4

Adverse Events

5 mg Ertugliflozin: Week 1-54

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

5 mg/5 mg Ertugliflozin: Week 1-54

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

5 mg/15 mg Ertugliflozin: Week 1-12 (Ertu 5 mg)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

5 mg/15 mg Ertugliflozin: Week 12-54 (Ertu 15 mg)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo: Week 1-54

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	5 mg Ertugliflozin: Week 1-54 n=63 participants at risk Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	5 mg/5 mg Ertugliflozin: Week 1-54 n=22 participants at risk Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	5 mg/15 mg Ertugliflozin: Week 1-12 (Ertu 5 mg) n=26 participants at risk After the first randomization on Day 1, participants received 5mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study.	5 mg/15 mg Ertugliflozin: Week 12-54 (Ertu 15 mg) n=26 participants at risk After the second randomization at WK12, participants received 15mg ERTU QD and placebo to 5 mg ERTU QD from WK12 to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.	Placebo: Week 1-54 n=55 participants at risk Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Infections and infestations COVID-19 pneumonia	0.00% 0/63 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	4.5% 1/22 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Infections and infestations Post procedural infection	1.6% 1/63 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Injury, poisoning and procedural complications Foot fracture	1.6% 1/63 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Injury, poisoning and procedural complications Tibia fracture	1.6% 1/63 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Metabolism and nutrition disorders Hyperglycaemia	1.6% 1/63 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/63 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.

Other adverse events

Other adverse events
Measure	5 mg Ertugliflozin: Week 1-54 n=63 participants at risk Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained on 5 mg ERTU and placebo to 15 mg ERTU. Participants remained on their background metformin with/without insulin treatment throughout the study.	5 mg/5 mg Ertugliflozin: Week 1-54 n=22 participants at risk Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participants who met the up-titration criteria at the WK12 second randomization were re-randomized to remain on 5 mg ERTU and placebo to 15 mg ERTU from WK12 to WK54.	5 mg/15 mg Ertugliflozin: Week 1-12 (Ertu 5 mg) n=26 participants at risk After the first randomization on Day 1, participants received 5mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study.	5 mg/15 mg Ertugliflozin: Week 12-54 (Ertu 15 mg) n=26 participants at risk After the second randomization at WK12, participants received 15mg ERTU QD and placebo to 5 mg ERTU QD from WK12 to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.	Placebo: Week 1-54 n=55 participants at risk Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study.
Gastrointestinal disorders Abdominal pain	1.6% 1/63 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	9.1% 2/22 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	5.5% 3/55 • Number of events 6 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/63 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	9.1% 2/22 • Number of events 3 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.3% 4/55 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Gastrointestinal disorders Gastritis	6.3% 4/63 • Number of events 5 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Gastrointestinal disorders Nausea	3.2% 2/63 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	13.6% 3/22 • Number of events 3 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	15.4% 4/26 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.3% 4/55 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Gastrointestinal disorders Vomiting	1.6% 1/63 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	9.1% 2/22 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	15.4% 4/26 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	5.5% 3/55 • Number of events 3 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
General disorders Pyrexia	6.3% 4/63 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	4.5% 1/22 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Infections and infestations COVID-19	7.9% 5/63 • Number of events 5 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	4.5% 1/22 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.3% 4/55 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Infections and infestations Gastroenteritis	4.8% 3/63 • Number of events 3 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	9.1% 5/55 • Number of events 6 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Infections and infestations Influenza	6.3% 4/63 • Number of events 5 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	5.5% 3/55 • Number of events 3 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Infections and infestations Nasopharyngitis	7.9% 5/63 • Number of events 6 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	4.5% 1/22 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	5.5% 3/55 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Infections and infestations Pharyngitis	1.6% 1/63 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	9.1% 2/22 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	1.8% 1/55 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Infections and infestations Upper respiratory tract infection	14.3% 9/63 • Number of events 11 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	4.5% 1/22 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	10.9% 6/55 • Number of events 8 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Investigations Urine albumin/creatinine ratio increased	1.6% 1/63 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.6% 2/55 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/63 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	4.5% 1/22 • Number of events 5 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.3% 4/55 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Metabolism and nutrition disorders Hypoglycaemia	11.1% 7/63 • Number of events 35 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	9.1% 2/22 • Number of events 3 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	11.5% 3/26 • Number of events 12 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	19.2% 5/26 • Number of events 40 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	12.7% 7/55 • Number of events 9 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/63 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Nervous system disorders Dizziness	0.00% 0/63 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Nervous system disorders Headache	7.9% 5/63 • Number of events 5 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	4.5% 1/22 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	3.8% 1/26 • Number of events 1 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	11.5% 3/26 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	5.5% 3/55 • Number of events 4 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/63 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/22 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/26 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	7.7% 2/26 • Number of events 2 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.	0.00% 0/55 • Up to 56 weeks. All-Cause Mortality is reported for all randomized participants. Serious adverse events and other adverse events are reported for all participants who received at least 1 dose of treatment.

Additional Information

Clinical Trials Disclosure

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Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
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