Ertugliflozin and Sitagliptin Co-administration Factorial Study (MK-8835-005)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/13/2015
Start Date:April 2014
End Date:May 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin Compared With Ertugliflozin Alone and Sitagliptin Alone, in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Metformin Monotherapy

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.

This study will include a 1-week screening period; an up to 12-week metformin titration/dose
stabilization period; a 2-week single-blind placebo run-in period; a 52-week (26-week Phase
A and (26-week Phase B) double-blind treatment period and a post-treatment telephone contact
14 days after the last dose of study medication.

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 <=11.0% (>=58 mmol/mol and <=97 mmol/mol) OR On metformin monotherapy
(>=1500 mg/day) for <8 weeks with a Visit 1/Screening A1C >=7.5% and <=11.0% (>=58
mmol/mol and <=97 mmol/mol) OR On metformin monotherapy <1500 mg/day with a Visit
1/Screening A1C >=8.0% and <=11.5% (>=64 mmol/mol and <=102 mmol/mol)

- Body mass index (BMI) >=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 (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., <=7 days] during concomitant illness or other stress), other injectable
anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone
or rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors, alpha
glucosidase inhibitors or meglitinides, dipeptidyl-peptidase 4 inhibitor (DPP-4
inhibitor), sulfonylureas (SUs), bromocriptine (Cycloset™), colesevelam (Welchol™),
any other AHA with the exception of the protocol-approved agents

- Is on a weight-loss program or weight-loss medication or other medication associated
with weight changes and is not weight stable prior to study start

- Has undergone bariatric surgery within the past 12 months or >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 <=5 years prior to study start, except for adequately treated
basal cell or squamous cell skin cancer or in situ cervical cancer

- A known history of human immunodeficiency virus (HIV)

- A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a
clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative
or myelodysplastic syndromes, thrombocytopenia)

- A medical history of active liver disease (other than non-alcoholic hepatic
steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or
symptomatic gallbladder disease

- Any clinically significant malabsorption condition

- Current treatment for hyperthyroidism

- On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior
study start

- On a previous clinical study with ertugliflozin

- eGFR (using the 4-variable Modification of Diet in Renal Disease Study Equation
(MDRD) equation) <60 mL/min/1.73 m^2

- Serum creatinine >= 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 <12 g/dL (120 g/L) for males and <11 g/dL (110 g/L) for females.

- Participated in other studies involving investigational drug(s) 30 days prior to
study start

- Surgical procedure within 6 weeks prior to study start or major surgery planned
during the trial

- Positive urine pregnancy test

- Pregnant or breast-feeding, or planning to conceive during the trial, including 14
days following the last dose of study medication

- Planning to undergo hormonal therapy in preparation for egg donation during the
trial, including 14 days following the last dose of study medication

- Routinely consumes >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
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