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 - N/A

Merck Sharp & Dohme Corp. a subsidiary of Merck &Co., Inc0 sites600 target enrollmentNovember 10, 2010

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 10, 2010

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp. a subsidiary of Merck &Co., Inc

Eligibility Criteria

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.