Effect of Continuing Versus Holding Metformin During Hospitalizations.

University of Illinois

Status and phase: Enrolling; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT06296836

2024-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Metformin continuation

Active Comparator group

Description:

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

Treatment:

Drug: Metformin

Metformin discontinuation

No Intervention group

Description:

Holding home metformin regimen during hospitalization to an internal medicine service