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 & Co., Inc.0 sites600 target enrollmentOctober 5, 2010

Overview

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

Sponsor

•\- 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
•\- 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

•\- 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