512
Participants
Start Date
May 6, 2024
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2029
Metformin
Metformin is an oral anti-hyperglycemic agent widely used as first-line treatment for type II diabetes to improve glycemic control. It is the fourth most commonly prescribed drug in the United States. Participants will receive commercially available extended-release metformin 500mg tablets manufactured by Granules India Limited, Hyderabad, India and then sourced, packaged, and labeled for the study by Sharp Labs. The study will follow standard dosing procedures for extended-release metformin. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.
Placebo
The study will use matching placebo tablets that are almost indistinguishable from the 500 mg metformin ER tablets. Participants will begin by taking 1x500 mg pill once a day, and then the dose will be increased in 500 mg/day increments every 5 days as tolerated, up to a maximum dose of 1500 mg daily.
RECRUITING
Hospital for Special Surgery, New York
RECRUITING
The University of North Carolina at Chapel Hill, Chapel Hill
RECRUITING
Emory University, Atlanta
RECRUITING
University of Kentucky, Lexington
RECRUITING
The Ohio State University, Columbus
RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
University of Iowa Hospitals and Clinics, Iowa City
RECRUITING
University of Nebraska Medical Center, Omaha
RECRUITING
Brigham and Women's Hospital, Boston
Collaborators (1)
Arthritis Foundation
OTHER
Brigham and Women's Hospital
OTHER