Effect of Continuing Versus Holding Metformin During Hospitalizations.

NCT ID: NCT06296836

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-21

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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The purpose of this study is to determine what the effects of the routine practice of holding metformin in hospitalized patients with type 2 diabetes are on outcomes.

The objectives of this study are to determine how holding versus continuing metformin during hospitalization to an internal medicine service affects the incidences of lactic acidosis, mean anion gap, mean glucose levels, low and very high blood sugars, GI effects after discharge, lack of continuation of metformin upon discharge, mean glucose levels, lengths of stay, and 30-day mortality.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel, prospective trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin continuation

Continuation of home metformin regimen during hospitalization to an internal medicine service

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Continuation of home metformin

Metformin discontinuation

Holding home metformin regimen during hospitalization to an internal medicine service

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metformin

Continuation of home metformin

Intervention Type DRUG

Other Intervention Names

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Glucophage

Eligibility Criteria

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Inclusion Criteria

* Adult (18+ years of age)
* Admitted to an internal medicine service.
* On Metformin prior to admission.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mathew Thambi, PharmD, MPH

Role: CONTACT

312-497-5540

Emily Hanners, PharmD

Role: CONTACT

312-355-0431

Facility Contacts

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Mathew M Thambi, PharmD, MPH

Role: primary

Other Identifiers

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2024-001

Identifier Type: -

Identifier Source: org_study_id

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