Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-16

Study Completion Date

2017-04-18

Brief Summary

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This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.

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Detailed Description

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The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ertugliflozin 5 mg

Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104

Group Type EXPERIMENTAL

Ertugliflozin 5 mg

Intervention Type DRUG

Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104

Placebo to Ertugliflozin

Intervention Type DRUG

Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104

Placebo to Glimepiride

Intervention Type DRUG

Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.

Metformin

Intervention Type DRUG

Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.

Sitagliptin

Intervention Type DRUG

Open label, oral, once daily, rescue medication as required.

Ertugliflozin 15 mg

Ertugliflozin 15 mg QD from Day 1 to Week 104

Group Type EXPERIMENTAL

Ertugliflozin 5 mg

Intervention Type DRUG

Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104

Ertugliflozin 10 mg

Intervention Type DRUG

Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.

Placebo to Glimepiride

Intervention Type DRUG

Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.

Metformin

Intervention Type DRUG

Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.

Sitagliptin

Intervention Type DRUG

Open label, oral, once daily, rescue medication as required.

Glimepiride up to 8 mg

Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104

Group Type ACTIVE_COMPARATOR

Glimerpiride

Intervention Type DRUG

Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose

Placebo to Ertugliflozin

Intervention Type DRUG

Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104

Metformin

Intervention Type DRUG

Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.

Sitagliptin

Intervention Type DRUG

Open label, oral, once daily, rescue medication as required.

Interventions

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Ertugliflozin 5 mg

Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104

Intervention Type DRUG

Ertugliflozin 10 mg

Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.

Intervention Type DRUG

Glimerpiride

Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose

Intervention Type DRUG

Placebo to Ertugliflozin

Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104

Intervention Type DRUG

Placebo to Glimepiride

Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.

Intervention Type DRUG

Metformin

Participants are to remain on their stable doses of metformin (oral, \>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \<1500 at screening are up-titrated to \>= 1500 daily.

Intervention Type DRUG

Sitagliptin

Open label, oral, once daily, rescue medication as required.

Intervention Type DRUG

Other Intervention Names

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MK-8835 MK-8355

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of T2DM in accordance to American Diabetes Association guidelines
* On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.
* Body Mass Index (BMI) ≥18.0 kg/m\^2
* Male or female not of reproductive potential
* If a female of reproductive potential, agree to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug.

Exclusion Criteria

* History or presence of type 1 diabetes mellitus or a history of ketoacidosis
* History of other specific types of diabetes (eg, 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
* Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy
* Known hypersensitivity or intolerance to metformin or glimepiride
* On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (\>=5% change in body weight in the last 6 months)
* History of bariatric surgery less than 12 months prior to study participation
* 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
* Active, obstructive uropathy or an indwelling urinary catheter
* 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
* Known history of Human Immunodeficiency Virus (HIV)
* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells
* A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease
* Any clinically significant malabsorption condition
* Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation
* Previous randomization in a study with ertugliflozin
* Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period
* A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial
* A positive urine pregnancy test
* Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug
* Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug
* Consumption of more than 2 alcoholic drinks per day or engages in binge drinking
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No