A Study of the Efficacy and Safety of Ertugliflozin in Participants With Type 2 Diabetes Mellitus With Stage 3 Chronic Kidney Disease Who Have Inadequate Glycemic Control on Antihyperglycemic Therapy (MK-8835-001)
CompletedPhase 3Results postedLast updated 10 September 2018
What this trial tests
Phase 3 trial testing Ertugliflozin 5 mg in Type 2 Diabetes Mellitus in 468 participants. Completed in 28 September 2016.
25 and older, any sex, with Type 2 Diabetes Mellitus. 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.
Change From Baseline in A1C at Week 26 - Excluding Rescue ApproachPrimary· Baseline and Week 26
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Group
Value
95% CI
Ertugliflozin 5 mg
-0.29
-0.44 – -0.14
Ertugliflozin 15 mg
-0.41
-0.56 – -0.27
Placebo
-0.26
-0.41 – -0.11
Percentage of Participants Who Experienced an Adverse Event (AE)Primary· Up to 54 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Group
Value
95% CI
Ertugliflozin 5 mg
84.8
Ertugliflozin 15 mg
74.2
Placebo
81.2
Percentage of Participants Who Discontinued Study Treatment Due to an AEPrimary· Up to 52 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Group
Value
95% CI
Ertugliflozin 5 mg
8.2
Ertugliflozin 15 mg
3.9
Placebo
5.2
Change From Baseline in A1C at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue ApproachSecondary· Baseline and Week 26
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Group
Value
95% CI
Ertugliflozin 5 mg
-0.31
-0.49 – -0.13
Ertugliflozin 15 mg
-0.37
-0.56 – -0.18
Placebo
-0.28
-0.47 – -0.08
Change From Baseline in Body Weight at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue ApproachSecondary· Baseline and Week 26
This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Group
Value
95% CI
Ertugliflozin 5 mg
-1.31
-1.86 – -0.76
Ertugliflozin 15 mg
-1.39
-1.97 – -0.81
Placebo
0.46
-0.13 – 1.04
Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue ApproachSecondary· Baseline and Week 26
This change from baseline reflects the Week 26 sitting systolic blood pressure minus the Week 0 sitting systolic blood pressure. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Group
Value
95% CI
Ertugliflozin 5 mg
-2.33
-4.98 – 0.33
Ertugliflozin 15 mg
-4.36
-7.11 – -1.62
Placebo
-0.90
-3.73 – 1.92
Change From Baseline in FPG at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue ApproachSecondary· Baseline and Week 26
This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Group
Value
95% CI
Ertugliflozin 5 mg
-11.76
-21.07 – -2.45
Ertugliflozin 15 mg
-20.47
-30.20 – -10.73
Placebo
-4.95
-15.03 – 5.13
Percentage of Participants With A1C <7.0% (<53 mmol/Mol) at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue ApproachSecondary· Week 26
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
Group
Value
95% CI
Ertugliflozin 5 mg
16.2
Ertugliflozin 15 mg
11.3
Placebo
12.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 54 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in participants with Type 2 diabetes mellitus with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The duration of this trial will be up to 67 weeks. This study will consist of a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary objective of this trial is to assess the hemoglobin A1C (A1C)-lowering efficacy of the addition of ertugliflozin compared to the addition of placebo with an underlying hypothesis that addition of treatment with ertugliflozin provides greater reduction in A1C compared to the addition of placebo; the primary objective will be tested for both 5-mg and 15-mg doses of ertugliflozin.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04600921 — Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study
· Phase 3
· terminated
NCT04071626 — Evaluating Metabolic Mechanisms of Ertugliflozin in Diabetes & Heart Failure
· Phase 4
· terminated
NCT04029480 — Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
· Phase 3
· completed
NCT02630706 — A Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Participants With Type 2 Diabetes and Inadequate G
· Phase 3
· completed
NCT02099110 — Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)
· Phase 3
· completed
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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: 10 September 2018
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/NCT01986855.