Adults 18 to 65, any sex, with Diabetes Mellitus, Type 2 or Adult. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cumulative Urinary Glucose Excretion Over 0 to 24 HoursPrimary· 0 to 24 hours after the morning dose
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted from 0 to 24 hours after the morning dose is presented in the table below.
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
69.45
54.20 – 84.70
Cohort 1: Ertugliflozin 2 mg Once Daily
70.43
55.19 – 85.68
Cohort 2: Ertugliflozin 2 mg Twice Daily
78.29
61.87 – 94.72
Cohort 2: Ertugliflozin 4 mg Once Daily
80.54
64.05 – 97.02
Urinary Glucose Excretion by Time PeriodPrimary· At 0-4 hrs, 4-8 hrs, 8-12 hrs, and 12-24 hrs after the AM dose (up to 24 hours)
Urine for analysis of glucose was collected at prespecified intervals. Each participant emptied his/her bladder just before dosing, and the collection started after the morning dose (collection times: 0-4 hours, 4-8 hours, 8-12 hours, and 12-24 hours after the morning dose). The average amount of urinary glucose excreted during the pre-specified time frame is presented in the table below.
0 to 4 hours post dose
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
12.88
± 14.66
Cohort 1: Ertugliflozin 2 mg Once Daily
14.03
± 11.63
Cohort 2: Ertugliflozin 2 mg Twice Daily
14.66
± 11.81
Cohort 2: Ertugliflozin 4 mg Once Daily
16.34
± 10.16
4 to 8 hours post dose
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
15.42
± 12.00
Cohort 1: Ertugliflozin 2 mg Once Daily
17.87
± 12.60
Cohort 2: Ertugliflozin 2 mg Twice Daily
16.97
± 11.64
Cohort 2: Ertugliflozin 4 mg Once Daily
19.78
± 14.02
8 to 12 hours post dose
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
14.47
± 8.84
Cohort 1: Ertugliflozin 2 mg Once Daily
11.99
± 7.70
Cohort 2: Ertugliflozin 2 mg Twice Daily
14.30
± 10.52
Cohort 2: Ertugliflozin 4 mg Once Daily
12.91
± 6.93
12 to 24 hours post dose
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
26.76
± 20.10
Cohort 1: Ertugliflozin 2 mg Once Daily
26.31
± 21.11
Cohort 2: Ertugliflozin 2 mg Twice Daily
31.47
± 22.71
Cohort 2: Ertugliflozin 4 mg Once Daily
32.94
± 21.08
24-hour Weighted Mean Plasma GlucosePrimary· Up to 24 hours
Blood was collected during each treatment period at pre-dose (fasted) on Day 1 (Hour 0) and post-dose (fed) on Day 1 at 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 12.5, 13, 14, 15, 16, 18, and 24 hours.
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
173.6
± 26.94
Cohort 1: Ertugliflozin 2 mg Once Daily
175.7
± 29.88
Cohort 2: Ertugliflozin 2 mg Twice Daily
169.1
± 35.91
Cohort 2: Ertugliflozin 4 mg Once Daily
170.4
± 41.26
Weighted Mean Postprandial Plasma GlucosePrimary· At 0-5 hours, 5-12 hrs, and 12-18 hrs after the morning dose (up to 18 hours)
The weighted mean postprandial glucose over the specified intervals were analyzed by cohort.
0 to 5 hours
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
200.1
± 38.27
Cohort 1: Ertugliflozin 2 mg Once Daily
187.2
± 41.37
Cohort 2: Ertugliflozin 2 mg Twice Daily
194.1
± 46.87
Cohort 2: Ertugliflozin 4 mg Once Daily
189.9
± 53.17
5 to 12 hours
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
159.4
± 25.76
Cohort 1: Ertugliflozin 2 mg Once Daily
159.8
± 28.46
Cohort 2: Ertugliflozin 2 mg Twice Daily
160.5
± 42.14
Cohort 2: Ertugliflozin 4 mg Once Daily
161.5
± 40.70
12 to 18 hours
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
180.7
± 35.98
Cohort 1: Ertugliflozin 2 mg Once Daily
190.7
± 35.38
Cohort 2: Ertugliflozin 2 mg Twice Daily
182.6
± 40.79
Cohort 2: Ertugliflozin 4 mg Once Daily
181.9
± 40.79
Fasting C-peptidePrimary· Up to 24 hours (0 and 24 hours)
The fasting c-peptide was analyzed by cohort using a mixed-effects model with sequence, period, and treatment as fixed effects and participant within sequence as a random effect.
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
2.82
2.54 – 3.11
Cohort 1: Ertugliflozin 2 mg Once Daily
2.76
2.47 – 3.04
Cohort 2: Ertugliflozin 2 mg Twice Daily
3.00
2.64 – 3.35
Cohort 2: Ertugliflozin 4 mg Once Daily
2.99
2.64 – 3.34
Number of Participants Experiencing an Adverse EventPrimary· Up to 16 days
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug.
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
5
Cohort 1: Ertugliflozin 2 mg Once Daily
8
Cohort 2: Ertugliflozin 2 mg Twice Daily
3
Cohort 2: Ertugliflozin 4 mg Once Daily
5
Number of Participants Discontinuing Study Drug Due to an Adverse EventPrimary· Up to 8 days (Day 1 in each dosing period)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. The table below includes all data collected since the first dose of study drug. Data include participants discontinued due to adverse events, participants with dose reduced or temporary discontinuation due to adverse events.
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
0
Cohort 1: Ertugliflozin 2 mg Once Daily
1
Cohort 2: Ertugliflozin 2 mg Twice Daily
0
Cohort 2: Ertugliflozin 4 mg Once Daily
0
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for ErtugliflozinPrimary· 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
Pharmacokinetic (PK) parameter of AUClast for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
PK parameter of Cmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
19.51
± 39
Cohort 1: Ertugliflozin 2 mg Once Daily
26.98
± 37
Cohort 2: Ertugliflozin 2 mg Twice Daily
34.80
± 23
Cohort 2: Ertugliflozin 4 mg Once Daily
50.83
± 25
Time Taken to Reach the Maximum Observed Plasma Concentration (Tmax) of ErtugliflozinPrimary· 0 predose, 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 10, 12, 18, 24 hours postdose
PK parameter of Tmax for study drug. Actual sample collection times (relative to the AM dose) were used for the pharmacokinetic analysis.
Group
Value
95% CI
Cohort 1: Ertugliflozin 1 mg Twice Daily
6.00
0.500 – 12.0
Cohort 1: Ertugliflozin 2 mg Once Daily
1.00
0.500 – 5.50
Cohort 2: Ertugliflozin 2 mg Twice Daily
6.00
0.500 – 8.00
Cohort 2: Ertugliflozin 4 mg Once Daily
1.00
0.500 – 6.00
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 16 days (including 7-day follow-up for each period).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using 2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu, PF-04971729/MK-8835) each administered once vs twice daily (morning \[AM\] and evening \[PM\]) in adults with type 2 diabetes.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 21 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01054300.