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A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone.
The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Central Alabama Research
Birmingham, Alabama, United States
Central Alabama Research
Homewood, Alabama, United States
Terence T. Hart, Md
Muscle Shoals, Alabama, United States
International Institute Of Clinical Research
Ozark, Alabama, United States
Clinical Research Advantage
Mesa, Arizona, United States
Elite Clinical Studies, Llc
Phoenix, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Medical Investigations, Inc.
Little Rock, Arkansas, United States
Aureus Research, Inc.
Little Rock, Arkansas, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Start Date
July 1, 2012
Primary Completion Date
January 1, 2014
Completion Date
January 1, 2014
Last Updated
May 15, 2017
1,282
ACTUAL participants
Saxagliptin
DRUG
Metformin XR
DRUG
Dapagliflozin
DRUG
Placebo matching with Dapagliflozin
DRUG
Placebo matching with Saxagliptin
DRUG
Lead Sponsor
AstraZeneca
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 ConditionsNCT06671587