A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - 65
Updated:12/31/2016
Start Date:July 2015
End Date:September 2017
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase IIa, Multicenter, Placebo- and Active-controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo in Subjects With Type 2 Diabetes Mellitus

This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide;
Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes
mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000
mg/day).

The trial will include a 1-week screening period; an 8-week antihyperglycemic agent (AHA)
washout period, if required; a 14-week blinded therapy period (which includes single-blind
run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last
dose of investigational product.

The primary hypotheses of the trial are to assess the hemoglobin A1c (HbA1C)-lowering
efficacy of the addition of MK-8521 relative to placebo and to evaluate safety and
tolerability of MK-8521.


Inclusion Criteria:

- Have T2DM in accordance with American Diabetes Association guidelines

- Be on metformin monotherapy (>-1000 mg/day: metformin IR or metformin XR) for at
least 12 weeks prior to study start with a hemoglobin A1C (A1C) >-7.5 and <-10.5% OR
Be on dual therapy with metformin (>-1000 mg/day: dose stable for at least 4 weeks
prior to study start) with an A1C of >-7.0% and <-10.0% and a second AHA and be
willing to washout the second AHA. Allowable AHAs are dipeptidyl peptidase 4 (DPP-4
inhibitors), alpha-glucosidase inhibitors, sulfonylureas, and glinides.

- Have a body mass index (BMI) ≥23 kg/m2 and ≤40 kg/m2

- Is a female who is not of reproductive potential, or is a female of reproductive
potential who agrees to avoid becoming pregnant: while receiving study drug and for
14 days after the last dose of study drug

Exclusion Criteria:

- Have a history of type 1 diabetes or a history of diabetic ketoacidosis

- Has a 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)

- Has been treated with any gut-derived incretin hormone glucagon-like peptide 1
(GLP-1) receptor agonist (e.g. Byetta™, Victoza™ or investigational agents) within
the last 6 months or has had GLP-1 receptor agonist discontinued due to
gastrointestinal intolerance or lack of efficacy. Note: treatment with a GLP-1
receptor agonist that was discontinued >6 months prior to study start is not an
exclusion if the GLP-1 receptor agonist was discontinued for reasons other than
gastrointestinal intolerance or lack of efficacy.

- Has a history of clinically significant gastrointestinal disorder (including diabetic
gastroparesis; irritable bowel disease; recurrent episodes of nausea, vomiting,
diarrhea and abdominal pain)

- Has a history of clinically significant and active, immunological, respiratory,
genitourinary or major neurological (including stroke, transient ischemic attack and
chronic seizures) abnormalities or diseases

- Has a history of cardiovascular disease (including diabetic cardiomyopathy) or
significant cardiac condition (including a history of myocardial infarction, stable
or unstable angina, arterial revascularization, pathologic, symptomatic or sustained
tachyarrhythmia [e.g. atrial fibrillation, sustained supraventricular tachycardia,
symptomatic non-sustained supraventricular tachycardia, ventricular tachycardia,
ventricular fibrillation, Wolf-Parkinson-White syndrome, congenital long QT syndrome,
etc.]) or heart failure

- Has a family history of medullary carcinoma of the thyroid or multiple endocrine
neoplasm type-2 syndrome

- Has active diabetic proliferative retinopathy or a history of maculopathy

- Has human immunodeficiency virus (HIV)

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

- Is on a weight loss medication or has undergone bariatric surgery

- Has a history of acute or chronic pancreatitis of any etiology

- Had an event of severe hypoglycemia with neuroglycopenia in the past 12 months

- Has a positive urine pregnancy test

- Is pregnant or breast-feeding, or is planning to conceive during the trial, including
14 days following the last dose of investigational product

- Routinely consumes >1 alcoholic drinks per day or >7 alcoholic drinks per week or
engages in binge drinking

- Routinely consumes ≥480mg /day caffeine in caffeinated beverages (1 cup of coffee
contains approximately 120 mg of caffeine

- Is taking a beta blocker or medications with sympathomimetic activity (e.g.
pseudoephedrine, phenylpropanolamine, etc.)

- Is currently a user of nicotine or nicotine containing products or does not agree to
refrain from using nicotine during the trial, including 14 days following the last
dose of investigational product

- Is currently a user of any illicit drugs (including any marijuana use) or has a
history of drug (including alcohol) abuse within approximately 5 years

- has other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or blinded
investigational product administration
We found this trial at
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Greensboro, North Carolina 27401
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Morehead City, North Carolina 28557
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North Ryde, 2113
Phone: 61 2 8988 8428
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