Phase 3
Completed N=461
A Study of the Efficacy and Safety of Ertugliflozin Monotherapy in the Treatment of Participants With Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise (MK-8835-003, VERTIS MONO)
Source: ClinicalTrials.gov NCT01958671 ↗Enrolled (actual)
461
Serious AEs
5.4%
Results posted
Sep 2017
Primary outcomePrimary: Change From Baseline In A1C at Week 26 — -0.79; -0.96; 0.20 Percent — p=<0.001
◆ Published Evidence
Highly cited
145citations · ~16 / year
Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone.
Summary
This trial will evaluate the efficacy and safety of ertugliflozin monotherapy in the treatment of participants with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on diet and exercise. This trial consists of a run-in period of 3 to 11 weeks, a 26-week placebo-controlled treatment period (Phase A), and a 26-week active treatment period (Phase B). The primary hypotheses of the trial are that at Week 26, the mean reduction from baseline in hemoglobin A1c (A1C) for 15 mg ertugliflozin is greater than that for placebo and the mean reduction from baseline in A1C for 5 mg ertugliflozin is greater than that for placebo.
Linked Publications (5)
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Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone.
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Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials.
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Effects of Ertugliflozin on Liver Enzymes in Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis of Phase 3 Trials.
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The effects of ertugliflozin on β-cell function: Pooled analysis from four phase 3 randomized controlled studies.
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Population Pharmacokinetic Analyses of Ertugliflozin in Select Ethnic Populations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline In A1C at Week 26 |
-0.79; -0.96; 0.20 | <0.001 sig |
| PRIMARY Percentage of Participants Experiencing An Adverse Event (AE) |
64.1; 62.5; 66.7 | — |
| PRIMARY Percentage of Participants Discontinuing Study Treatment Due to an AE |
4.5; 3.9; 6.5 | — |
| SECONDARY Change From Baseline in FPG at Week 26 |
-33.96; -43.44; 0.57 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
-3.18; -3.58; -1.42 | <0.001 sig |
| SECONDARY Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26 |
28.2; 35.8; 13.1 | <0.001 sig |
| SECONDARY Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level |
260.32; 262.91; 256.21 | — |
| SECONDARY Change From Baseline in 2-hr PPG at Week 26 |
-64.15; -62.45; 4.88 | <0.001 sig |
| SECONDARY Baseline Sitting Systolic Blood Pressure (SBP) |
130.49; 129.67; 129.80 | — |
| SECONDARY Change From Baseline in SBP at Week 26 |
-5.54; -3.93; -2.22 | 0.015 sig |
| SECONDARY Baseline Sitting Diastolic Blood Pressure (DBP) |
78.46; 78.53; 78.13 | — |
| SECONDARY Change From Baseline in DBP at Week 26 |
-2.52; -1.10; -0.72 | 0.039 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of T2DM in accordance to American Diabetes Association guidelines
- Participants with no prior allowable oral anti-hyperglycemic agents (AHA) for at least 8 weeks prior to study participation or participants on a single allowable oral AHA at the start of study participation
- Participants on a single allowable AHA must be willing to discontinue this medication at the Screening Visit (S2) and remain off this medication for the duration of the trial. Allowable oral AHAs for discontinuation are metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glinides or alpha-glucosidase inhibitors.
Exclusion Criteria
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation
- A clinically significant electrocardiogram abnormality
- A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer
- A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor or metformin
- On a blood pressure or lipid altering medication that have not been on a stable dose for at least 4 weeks prior to study participation
- A surgical procedure within 4 weeks prior to study participation or planned major surgery during the trial
- Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial
- Pregnant or breast-feeding, or is expecting to conceive during the trial, including 14 days following the last dose of study drug
Data sourced from ClinicalTrials.gov (NCT01958671) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.