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A Phase 2, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of JTT-851 in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients either treated with metformin or treatment-naïve.
This is a randomized, double-blind, double-dummy, placebo and active-controlled (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated type 2 diabetic patients.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Birmingham, Alabama, United States
Dothan, Alabama, United States
Huntsville, Alabama, United States
Montgomery, Alabama, United States
Muscle Shoals, Alabama, United States
Glendale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Artesia, California, United States
Beverly Hills, California, United States
Start Date
September 1, 2012
Primary Completion Date
May 1, 2013
Completion Date
July 1, 2013
Last Updated
August 1, 2013
325
ACTUAL participants
JTT-851
DRUG
Glimepiride
DRUG
Placebo for Active
DRUG
Placebo for comparator
DRUG
Lead Sponsor
Akros Pharma Inc.
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 ConditionsNCT04943861