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Biguanides
Metformin ER for Aging (UPMCREMAP Trial)
Phase 3
Waitlist Available
Led By Matthew D Neal, MD, FACS
Research Sponsored by Matthew Neal MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to day 90 after surgery
Awards & highlights
UPMCREMAP Trial Summary
This trial will test whether metformin can reduce hospital free days at day 90 for adult patients undergoing elective surgery.
UPMCREMAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to day 90 after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to day 90 after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hospital free days (HFD)
Secondary outcome measures
Discharge disposition
Gastrointestinal intolerance
Hospital length of stay (LOS)
+11 moreSide effects data
From 2014 Phase 1 trial • 68 Patients • NCT0208408210%
Headache
8%
Diarrhoea
4%
Rhinitis
4%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
FDC 1000 Fasted
L+M 1000 Fed
FDC 1000 Fed
L+M 1000 Fasted
UPMCREMAP Trial Design
10Treatment groups
Experimental Treatment
Placebo Group
Group I: SPRY: Metformin LD-SC (low-dose, short course)Experimental Treatment1 Intervention
LD-SC (low-dose, short course)
Participants take Metformin ER 500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group II: SPRY: Metformin LD-LC (low-dose, long course)Experimental Treatment1 Intervention
LD-LC (low-dose, long course)
Participants take Metformin ER 500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group III: SPRY: Metformin LD-IC (low-dose, intermediate course)Experimental Treatment1 Intervention
LD-IC (low-dose, intermediate course)
Participants take Metformin ER 500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group IV: SPRY: Metformin ID-SC (intermediate-dose, short course)Experimental Treatment1 Intervention
ID-SC (intermediate-dose, short course)
Participants take Metformin ER 1000 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group V: SPRY: Metformin ID-LC (intermediate-dose, long course)Experimental Treatment1 Intervention
ID-LC (intermediate-dose, long course)
Participants take Metformin ER 1000 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group VI: SPRY: Metformin ID-IC (intermediate-dose, intermediate course)Experimental Treatment1 Intervention
ID-IC (intermediate-dose, intermediate course)
Participants take Metformin ER 1000 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group VII: SPRY: Metformin HD-SC (high-dose, short course)Experimental Treatment1 Intervention
HD-SC (high-dose, short course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 7-28 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group VIII: SPRY: Metformin HD-LC (high-dose, long course)Experimental Treatment1 Intervention
HD-LC (high-dose, long course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 90+ days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group IX: SPRY: Metformin HD-IC (high-dose, intermediate course)Experimental Treatment1 Intervention
HD-IC (high-dose, intermediate course)
After a 7 day run-in of Metformin ER 1000 mg, participants take Metformin ER 1500 mg daily for 29-90 days prior to their elective surgical procedure as determined by the patient's scheduling of their surgery. Participants take this same dose of Metformin ER for 90 days after their surgical procedure.
Group X: SPRY: PlaceboPlacebo Group1 Intervention
Participants are randomized to receive dose matched placebo to take daily for either short-, intermediate-, or long-course.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin ER
2019
Completed Phase 3
~450
Find a Location
Who is running the clinical trial?
Matthew Neal MDLead Sponsor
3 Previous Clinical Trials
3,341 Total Patients Enrolled
Derek C. Angus, MD, MPHLead Sponsor
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
75,948 Total Patients Enrolled
Frequently Asked Questions
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