Effect of Continuing Versus Holding Metformin During Hospitalizations.
1 other identifier
interventional
300
1 country
1
Brief Summary
A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2024
CompletedFirst Posted
Study publicly available on registry
March 6, 2024
CompletedStudy Start
First participant enrolled
January 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedFebruary 27, 2025
February 1, 2025
1.2 years
February 29, 2024
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Mean glucose levels
Average of daily glucose levels during hospitalization
During hospitalization
Secondary Outcomes (12)
Incidence of hyperglycemia greater than 300 mg/dl.
During hospitalization
Incidence of hypoglycemia (Glu = 54 - 70).
During hospitalization
Incidence of moderate hypoglycemia (Glu < 54)
During hospitalization
Incidence of severe hypoglycemia (Glu < 54 with symptoms)
During hospitalization
Mean lactic acid levels.
During hospitalization
- +7 more secondary outcomes
Other Outcomes (1)
Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm
During hospitalization
Study Arms (2)
Metformin continuation
ACTIVE COMPARATORContinuation of home metformin regimen during hospitalization to an internal medicine service
Metformin discontinuation
NO INTERVENTIONHolding home metformin regimen during hospitalization to an internal medicine service
Interventions
Eligibility Criteria
You may qualify if:
- Adult (18+ years of age)
- Admitted to an internal medicine service.
- On Metformin prior to admission.
You may not qualify if:
- Inability to take oral medications
- eGFR \< 30 ml/min/1.73 m2
- Dialysis
- Current Acidosis (pH \< 7.35) including diabetic ketoacidosis
- Child-Turcotte-Pugh class C hepatic cirrhosis
- Acute Decompensated Heart Failure
- Cognitively impaired and/or unable to consent
- Lack of or unwillingness to share contact information
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2024
First Posted
March 6, 2024
Study Start
January 21, 2025
Primary Completion
March 31, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share