PatientsVille.com LogoPatientsVille.com

Type 2 Diabetes Mellitus | 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)

Type 2 Diabetes Mellitus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

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 mgOne tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).

Drug:Ertugliflozin 10 mgOne tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).

Drug:Placebo to ErtugliflozinOne placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).

Drug:Metformin500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.

Drug:Placebo to Metformin1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.

Drug:GlimepirideDosing and titration of glimepiride as rescue therapy was determined by the investigator.

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.

Ertugliflozin 5 mg/Ertugliflozin 5 mgPhase A: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 5 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.

Ertugliflozin 15 mg/Ertugliflozin 15 mgPhase A: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Ertugliflozin 15 mg administered once daily for 26 weeks. Participants not rescued with metformin in Phase A, will receive placebo to metformin. Participants rescued with metformin in Phase A will continue to receive metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.

Placebo/MetforminPhase A: Placebo to ertugliflozin administered once daily for 26 weeks. Participants requiring rescue therapy will receive open-label metformin. Phase B: Participants not rescued with open-label metformin in Phase A will also receive blinded metformin up to twice daily for 26 weeks in addition to placebo. Participants rescued with metformin in Phase A will continue to receive open-label metformin. Participants requiring rescue therapy during Phase B will receive open-label glimepiride.

Study Status

Completed

Start Date: October 9, 2013

Completed Date: July 28, 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Change From Baseline In A1C at Week 26

Secondary Outcome: Change From Baseline in FPG at Week 26

Study sponsors, principal investigator, and references

Principal Investigator: Medical Director

Lead Sponsor:

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT01958671

Terra SG, Focht K, Davies M, Frias J, Derosa G, Darekar A, Golm G, Johnson J, Saur D, Lauring B, Dagogo-Jack S. Phase III, efficacy and safety study of ertugliflozin monotherapy in people with type 2 diabetes mellitus inadequately controlled with diet and exercise alone. Diabetes Obes Metab. 2017 May;19(5):721-728. doi: 10.1111/dom.12888. Epub 2017 Feb 22.

Discuss Diaformin