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Phase 2, Randomized, Double-Blind, Placebo and Active-Comparator Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 Administered Daily for 4 Weeks as Monotherapy in Patients With Type 2 Diabetes
To define the relative efficacy, safety and tolerability profiles of oral daily MBX-2982 at three different daily doses vs. placebo and sitagliptin 100 mg when administered for up to 4 weeks in patients that are treatment-naive or taking a single anti-diabetic medication (non-TZD, non-injectable).
Approximately 100 patients will be randomized in this study, 20 to each of of the three MBX-2982 treatment groups, 20 to placebo, and 20 to the sitagliptin group. Patients will be taking 3 tablets and 1 capsule daily. This sample size provides the minimum number expected to ensure a power of at least 80% to detect a 20% decrease in the weighted mean glucose level associated with an extended mixed meal tolerance test (with 2 standardized meals) relative to placebo after 4 weeks of daily treatment with MBX-2982, assuming a drop-out rate of 20% and a common SD of 25%.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Impact Clinical Trials
Los Angeles, California, United States
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States
United Medical Associates
Binghamton, New York, United States
dgd Research, Inc., a Cetero Research Co.
San Antonio, Texas, United States
Healthy Life Clinical Diagnostic Center
Tbilisi, Georgia
Georgian Diabetes Center
Tbilisi, Georgia
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, Georgia
Bharti Research Institute of Diabetes and Endocrinology
Karnāl, Haryana, India
Diabetes Thyroid Hormone Research Institute Pvt Ltd
Indore, M.p., India
Gandhi Endocrinology & Diabetes Centre
Rāmdaspeth, Nagpur, India
Start Date
December 1, 2009
Primary Completion Date
August 1, 2010
Completion Date
August 1, 2010
Last Updated
April 17, 2015
100
ACTUAL participants
MBX-2982
DRUG
MBX-2982
DRUG
MBX-2982
DRUG
Sitagliptin
DRUG
placebo
DRUG
Lead Sponsor
Gilead Sciences
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07296484