A 66-Week Extension to: 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: All

Target Recruitment: 600

Inclusion Criteria

-For patients not currently on AHA medication: A1C =7.0 and =10.0%

-For patients currently on oral AHA medication monotherapy or low dose dual oral combination therapy (except TZDs): A1C =6.5 and =9.0%

-BMI >20kg/m2 and <43kg/m2 (for Japan, BMI >18 kg/m2 and <43kg/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 (see Appendix 6.10).
-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 (refer to Appendix 6.1), 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:
-Acute coronary syndrome (such as MI or unstable angina)
-Coronary artery intervention (CABG or PTCA)
-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 glucose (FFSG) <126 mg/dL (<7.0 mmol/L) or >260 mg/dL (>14.4 mmol/L).

For protocol MK-3102-006-12 further exclusion criteria have been added:
- Patient has congestive heart failure (NYHA I - IV).
- Patient requires or is likely to require therapy with gemfibrozil or other strong CYP2C8 inhibitors.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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