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A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone
The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) added onto their blinded study medication
Age
18 - 77 years
Sex
ALL
Healthy Volunteers
No
Winston Technology, Inc.
Haleyville, Alabama, United States
Sunbelt Research Group, Llc
Mobile, Alabama, United States
Iicr, Inc.
Ozark, Alabama, United States
Clinical Research Advantage, Inc
Mesa, Arizona, United States
Nea Clinic
Jonesboro, Arkansas, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, United States
Impact Clinical Trials
Beverly Hills, California, United States
Lovelace Scientific Resources, Inc.
Beverly Hills, California, United States
Medical Group Of Encino
Encino, California, United States
Marin Endocrine Care And Research, Inc.
Greenbrae, California, United States
Start Date
March 1, 2006
Primary Completion Date
October 1, 2007
Completion Date
October 1, 2008
Last Updated
April 7, 2015
565
ACTUAL participants
Saxagliptin
DRUG
Saxagliptin
DRUG
Placebo
DRUG
pioglitazone
DRUG
rosiglitazone
DRUG
metformin
DRUG
Lead Sponsor
AstraZeneca
NCT06959901
NCT06574035
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 ConditionsNCT06861062