Status:
COMPLETED
Trial of an Intervention to Improve Metformin Persistence and Adherence
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Agency for Healthcare Research and Quality (AHRQ)
Conditions:
Metformin Adverse Reaction
Tolerance
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
Metformin is a safe and effective first-line drug for type 2 diabetes that is also widely recommended for weight loss and diabetes prevention. But, metformin is associated with gastrointestinal and ot...
Detailed Description
Results have been presented in a single study arm as the order in which patients received drug or placebo was unique for each patient.
Eligibility Criteria
Inclusion
- Diagnosis of diabetes, pre-diabetes, or obesity
- Previously attempted to take metformin for an above indication
- History of metformin intolerance (defined based on treating physician's assessment that a history of metformin intolerance (defined as the inability, due to side effects, to use metformin at the otherwise medically appropriate dose) exists, confirmed by the patient's recollection of the same history)
Exclusion
- Contraindication to metformin (i.e, advanced renal or liver disease, history of metformin attributed lactic acidosis, or advanced heart failure)
- Pregnant women
Key Trial Info
Start Date :
February 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03467763
Start Date
February 9 2018
End Date
August 1 2020
Last Update
December 7 2020
Active Locations (1)
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1
Weill Cornell Medical College
New York, New York, United States, 10065