Phase 3
Completed N=1,233
Ertugliflozin and Sitagliptin Co-administration Factorial Study (VERTIS FACTORAL, MK-8835-005)
Source: ClinicalTrials.gov NCT02099110 ↗Enrolled (actual)
1,233
Serious AEs
3.7%
Results posted
Nov 2017
Primary outcomePrimary: Change From Baseline in A1C at Week 26: Excluding Rescue Approach — -1.02; -1.08; -1.05; -1.49 Percentage — p=<0.001
◆ Published Evidence
Highly cited
164citations · ~21 / year
Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial.
Summary
This is a study of co-administration of ertugliflozin (MK-8835/PF-04971729) and sitagliptin given together or alone along with metformin in participants with Type 2 diabetes mellitus (T2DM) and inadequate glycemic control on metformin monotherapy. The primary hypothesis of this study is that ertugliflozin 15 mg daily plus sitagliptin 100 mg daily provides greater hemoglobin A1C (A1C)-lowering compared with sitagliptin 100 mg daily alone.
Linked Publications (5)
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Ertugliflozin plus sitagliptin versus either individual agent over 52 weeks in patients with type 2 diabetes mellitus inadequately controlled with metformin: The VERTIS FACTORIAL randomized trial.
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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: Excluding Rescue Approach |
-1.02; -1.08; -1.05; -1.49; -1.52 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach |
62.0; 57.7; 57.5; 58.8; 55.7 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach |
3.2; 3.2; 2.8; 3.3; 3.7 | — |
| SECONDARY Change From Baseline in Body Weight at Week 26: Excluding Rescue Approach |
-2.69; -3.74; -0.67; -2.52; -2.94 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Excluding Rescue Approach |
-35.73; -36.91; -25.56; -43.96; -48.70 | 0.004 sig |
| SECONDARY Percentage of Participants Achieving a Hemoglobin A1C of <7% (<53 mmol/Mol) (Raw Proportions): Excluding Rescue Approach |
26.4; 31.9; 32.8; 52.3; 49.2 | <0.001 sig |
| SECONDARY Change From Baseline in Static Beta-Cell Sensitivity to Glucose Index at Week 26; Excluding Rescue Approach |
8.62; 9.71; 21.11; 16.24; 11.51 | 0.155 |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure at Week 26: Excluding Rescue Approach |
-3.89; -3.69; -0.66; -3.42; -3.67 | 0.005 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus as per American Diabetes Association guidelines
- On metformin monotherapy (>=1500 mg/day) for >=8 weeks with a Visit 1/Screening A1C >=7.5% and =58 mmol/mol and =1500 mg/day) for =7.5% and =58 mmol/mol and =8.0% and =64 mmol/mol and =18.0 kg/m^2
- Male or female not of reproductive potential
- Female of reproductive potential who agrees to remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception
Exclusion Criteria
- History of type 1 diabetes mellitus or ketoacidosis
- History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant
- A known hypersensitivity or intolerance to any sodium glucose co-transporter 2 (SGLT2) inhibitor or sitagliptin
- Has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: Insulin of any type (except for short-term use [i.e., 12 months and is not weight stable prior to study start
- A 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 start
- Active, obstructive uropathy or indwelling urinary catheter
- History of malignancy = 1.3 mg/dL (115 µmol/L) for males and >= 1.2 mg/dL (106 µmol/L) for females
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times upper limit of normal
- Hemoglobin 2 alcoholic drinks per day or >14 alcoholic drinks per week or engages in binge drinking
- Donated blood or blood products within 6 weeks of study start
Data sourced from ClinicalTrials.gov (NCT02099110) 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.