MK0431 Monotherapy Safety and Efficacy in Type 2 Diabetes Mellitus Patients
This phase 3 study aims to evaluate the safety and effectiveness of MK0431 as a standalone treatment in patients with Type 2 Diabetes Mellitus, primarily focusing on the change in A1C levels from the beginning to the 24th week of the treatment.
Sitagliptin (MK0431)
+ Metformin - Rescue
+ Sitagliptin
Diabetes Mellitus+2
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.741 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Patients with type 2 diabetes mellitus * Patient is not pregnant or breastfeeding * Male or female patient unlikely to conceive * Patient not on an antihyperglycemic drug Exclusion Criteria: * Patient has history of type 1 diabetes mellitus * Patient has history of ketoacidosis * Patient requires insulin within 8 weeks prior to start of study * Patient on weight loss program and is not in maintenance phase * Patient taking weight loss medication within 8 weeks prior to start of study * Patient on or likely to require = 14 days or repeated courses of corticosteroids * Patient taking immunosuppressive/immunomodulating medication * Patient taking digoxin or other cardiac medication * Patient has undergone surgical general anesthesia within 30 days prior to start of study * Patient taking investigational drug within 8 weeks prior to start of study * Patient is diagnosed with liver disease * Patient has chronic myopathy, progressive neurological/neuromuscular disorder * Patient has with severe cardiac conditions within the last 6 months * Patient is Human immunodeficiency virus (HIV) positive * Patient has hematological disorder * Patient has history of malignancy * Patient has history of alcohol or drug abuse within the past 3 years
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
PlaceboGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives