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Type 2 Diabetes Mellitus | A Study To Evaluate The Efficacy And Safety Of Ertugliflozin In Participants With Type 2 Diabetes Mellitus And Inadequate Glycemic Control On Metformin Monotherapy (MK-8835-007).

Type 2 Diabetes Mellitus research study

What is the primary objective of this study?

This is an efficacy and safety study of ertugliflozin in participants with type 2 diabetes mellitus and inadequate glycemic control on metformin monotherapy. The primary study hypothesis is that at Week 26, the mean reduction from baseline in hemoglobin A1c (HbA1c) for ertugliflozin is greater than that for placebo.

Who is eligible to participate?

Inclusion Criteria: - Diagnosis of T2DM in accordance to American Diabetes Association guidelines - Participants must be receiving metformin monotherapy for less than 8 weeks prior to study participation or require change in their diabetes regimen to remain eligible to participate in the trial (including discontinuing anti-hyperglycemic agent [AHA] therapy) and must have a hemoglobin A1c of 7.0 to 10.5% (53-91 mmol/mol) after at least 8 weeks on a regimen of metformin monotherapy 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 glimepiride - 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 6 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Type 2 Diabetes Mellitus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ertugliflozin 5 mgErtugliflozin 5 mg orally (1 ertugliflozin 5 mg tablet and 1 placebo ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.

Drug:Ertugliflozin 15 mgErtugliflozin 15 mg orally (1 ertugliflozin 5 mg tablet and 1 ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.

Drug:Placebo to ErtugliflozinPlacebo to ertuglioflozin (1 placebo ertugliflozin 5 mg tablet and/or 1 placebo ertugliflozin 10 mg tablet), orally once daily from Day 1 to Week 104.

Other:GlimepirideGlimepiride will be used for glycemic rescue therapy (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) in the 26-week initial period. Blinded Glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period. Dosing and titration of blinded glimepiride is at the discretion of the investigator.

Drug:Placebo to GlimepiridePlacebo to glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period. Dosing and titration of placebo to glimepiride is at the discretion of the investigator.

Biological:Basal InsulinBasal insulin will be used for participants requiring rescue therapy in Phase B. Dosing and titration of basal insulin is at the discretion of the Investigator.

Drug:MetforminMetformin >=1500 mg/day, orally, once a day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ertuglifozin 5 mgErtugliflozin 5 mg orally, once daily from Day 1 to Week 104. Participants will receive 1 ertugliflozin 5 mg tablet and 1 placebo ertugliflozin 10 mg tablet per day. Participants requiring glycemic rescue during the 26-week initial treatment period (Phase A) will receive open-label glimepiride. This rescue will continue through the 78-week, double-blind, extension period (Phase B). If not rescued during Phase A, participants will receive placebo to glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) during Phase B. All participants will also receive metformin at a dose >=1500 mg/day in Phase A and B.

Ertugliflozin 15 mgErtugliflozin 15 mg orally, once daily from Day 1 to Week 104. Participants will receive 1 ertugliflozin 5 mg tablet and 1 ertugliflozin 10 mg tablet per day. Participants requiring glycemic rescue during the 26-week initial treatment period (Phase A) will receive open-label glimepiride. This rescue will continue through the 78-week, double-blind, extension period (Phase B). If not rescued during Phase A, participants will receive placebo to glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) during Phase B. All participants will also receive metformin at a dose >=1500 mg/day in Phase A and B.

Placebo to ErtugliflozinPlacebo to ertuglioflozin, orally once daily from Day 1 to Week 104. Participants will receive 1 placebo ertugliflozin 5 mg tablet and 1 placebo ertugliflozin 10 mg tablet per day. Participants requiring glycemic rescue during the 26-week initial treatment period (Phase A) will receive open-label glimepiride. This rescue will continue through the 78-week, double-blind, extension period (Phase B). If not rescued during Phase A, participants will receive blinded glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) during Phase B. All participants will also receive metformin at a dose >=1500 mg/day in Phase A and B.

Study Status

Completed

Start Date: December 13, 2013

Completed Date: August 3, 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Change from Baseline in Hemoglobin A1c

Secondary Outcome: Change from Baseline in Fasting Plasma Glucose

Study sponsors, principal investigator, and references

Principal Investigator: Medical Director

Lead Sponsor:

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT02033889

Rosenstock J, Frias J, Páll D, Charbonnel B, Pascu R, Saur D, Darekar A, Huyck S, Shi H, Lauring B, Terra SG. Effect of ertugliflozin on glucose control, body weight, blood pressure and bone density in type 2 diabetes mellitus inadequately controlled on metformin monotherapy (VERTIS MET). Diabetes Obes Metab. 2018 Mar;20(3):520-529. doi: 10.1111/dom.13103. Epub 2017 Oct 2.

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