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

Merck Sharp & Dohme Corp.0 sites663 target enrollmentOctober 5, 2010

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 5, 2010

End Date

January 3, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Merck Sharp & Dohme Corp.

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.
•\-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:
•\-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.