Effect of Continuing Versus Holding Metformin During Hospitalizations.

Effect of Continuing Versus Holding Metformin During Hospitalizations to Internal Medicine on Glucose Control, Acidosis, Abdominal Symptoms, Length of Stay, and Mortality.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Metformin

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metformin continuation; Continuation of home metformin regimen during hospitalization to an internal medicine service	Drug: Metformin; Continuation of home metformin
No Intervention: Metformin discontinuation; Holding home metformin regimen during hospitalization to an internal medicine service

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose levels	Average of daily glucose levels during hospitalization	During hospitalization

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Incidence of lactic acid levels greater than 2.0.	During hospitalization
Mean anion gap.	During hospitalization
Incidence of anion gap > 11	During hospitalization
Incidence of elevated lactic acid level or anion gap.	During hospitalization
Incidence of inadvertently not continuing metformin on discharge	At discharge
GI adverse effects	Within 3 days of discharge
Mortality	30 +/- 3 days after discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm	Mean daily glucose levels will only be included for the days in which the subjects received or did not receive metformin as per their assigned arm.	During hospitalization

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Emily Hanners; Dulal Bhaumik; Avisek Datta; Peggy Choye; Hailey Soni; Annesti Elmasri; Julie Jun; Colin Goodman

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: 2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No