Phase 3
Completed N=291
Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
Source: ClinicalTrials.gov NCT02226003 ↗Enrolled (actual)
291
Serious AEs
3.4%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach — -1.60; -1.68; -0.44 Percentage — p=< 0.001
◆ Published Evidence
Established
86citations · ~11 / year
Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study.
Summary
This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C (HbA1C) than placebo.
Linked Publications (5)
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Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study.
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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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Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus.
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The effects of ertugliflozin on β-cell function: Pooled analysis from four phase 3 randomized controlled studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach |
-1.60; -1.68; -0.44 | < 0.001 sig |
| PRIMARY Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach |
44.9; 44.8; 42.3 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach |
2.0; 2.1; 2.1 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach |
-48.25; -55.36; -9.30 | < 0.001 sig |
| SECONDARY Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach |
-82.80; -90.03; -20.38 | < 0.001 sig |
| SECONDARY Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26 |
35.7; 31.3; 8.3 | < 0.001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach |
-2.94; -3.04; -0.94 | < 0.001 sig |
| SECONDARY Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach |
-2.04; -3.98; 2.41 | 0.011 sig |
| SECONDARY Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach |
-0.44; -0.97; 1.21 | 0.184 |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus as per American Diabetes Association guidelines
- Not on antihyperglycemic agent (AHA) >=8 weeks with a Visit 1/Screening HbA1C >=8.0% and =64 mmol/mol and =7.5% and =58 mmol/mol and =7.5% and =58 mmol/mol and =18.0 kg/m^2
- Male or female not of reproductive potential
- Female of reproductive potential who agrees to (or have their partner agree to) remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.
Exclusion Criteria
- History of type 1 diabetes mellitus or diabetic 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 (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 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 (NCT02226003) 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.