A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

- Patient is currently not on an AHA medication (off for =14 weeks) and has a
Visit 1/Screening Visit A1C =7.0 and =10.0%.
- Patient is currently on oral AHA medication monotherapy or low-dose (i.e., =50%
maximum labeled dose of each agent) dual oral combination therapy [except
thiazolidinediones (TZDs)] and has a Visit 1/ Screening Visit A1C =6.5 and
=9.0%
- Patient has a body mass index (BMI) >20 kg/m2 and <43 kg/m2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis.
- Patient has previously been treated at any time with either an investigational or
marketed DPP-4 inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin)
or a GLP-1 receptor agonist (such as exenatide or liraglutide), or the patient has
required insulin therapy within 14 weeks prior to signing informed consent.
- Patient is on or likely to require treatment with warfarin or warfarin-like
anticoagulants, digoxin, any other medication with a narrow therapeutic index
- Patient has 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.
- Patient is HIV positive (as assessed by medical history).
- Patient has a diagnosis of CHF (congestive heart failure) with NYHA Class II - IV
cardiac status, patient has new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or had any of the following disorders within the past 3 months:
a. Acute coronary syndrome (such as MI or unstable angina)
b. Coronary artery intervention (CABG or PTCA)
c. Stroke or transient ischemic neurological disorder
- Patient has poorly controlled hypertension defined as systolic blood pressure of
=160 mm Hg or diastolic blood pressure of =90 mm Hg and blood pressure is not
considered likely to be under these limits by Visit 3/Week -2 with an adjustment in
antihypertensive medication.
- Patient has a history of a seizure disorder or central degenerative neurological
disorder.
- Patient has a history of chronic muscle disorder, including chronic myopathies or
muscular dystrophy.
- Patient has severe active peripheral vascular disease (such as manifested by
claudication with minimal activity, a non-healing ischemic ulcer, or disease which is
likely to require intervention such as with bypass or angioplasty).
- Patient has a history of malignancy or clinically important hematological disorder.
Exceptions: (1) Patients with adequately treated non-melanomatous skin carcinoma
or carcinoma in situ of the cervix may participate; (2) Patients with other
malignancies which have been successfully treated >5 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of screening. However, patients with a history of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia,
malignant melanoma, or renal cell carcinoma are ineligible for the study regardless of the time since treatment.
- Patient has a positive urine pregnancy test.
- At visit 2, Patient has a QTc interval >480 ms for females, and >470 ms for males.
- At visit 4, Patient has a site-fasting-fingerstick

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: After 12 weeks, to assess the effect of treatment with MK-3102 compared<br> with placebo on A1C.<br> ;<br> Secondary Objective: After 12 weeks, to assess the effect of treatment with MK-3102 compared<br> with placebo on 2-hour Post Meal Glucose (PMG).<br> ;Primary end point(s): HbA1C, 2- hours post meal glucose (PMG), Fasting Plasma Glucose (FPG)

Secondary Outcome Measures

Name	Time	Method

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