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Clinical Trial Details

Trial ID: L4386
Source ID: NCT06296836
Associated Drug: Metformin
Title: Effect of Continuing Versus Holding Metformin During Hospitalizations.
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Metformin
Outcome Measures: Primary: Mean glucose levels, Average of daily glucose levels during hospitalization, During hospitalization | Secondary: Incidence of hyperglycemia greater than 300 mg/dl., Glucose \> 300, During hospitalization|Incidence of hypoglycemia (Glu = 54 - 70)., Glu = 54 - 70, During hospitalization|Incidence of moderate hypoglycemia (Glu < 54), Glu \< 54, During hospitalization|Incidence of severe hypoglycemia (Glu < 54 with symptoms), Glu \< 54 with symptoms, During hospitalization|Mean lactic acid levels., Mean lactic acid levels, During hospitalization|Incidence of lactic acid levels greater than 2.0., Lactic acid \> 2.0, During hospitalization|Mean anion gap., Mean anion gap, a calculated value, During hospitalization|Incidence of anion gap > 11, Anion Gap \> 11, During hospitalization|Incidence of elevated lactic acid level or anion gap., Lactic acid \> 2.0 or Anion Gap \> 11, During hospitalization|Incidence of inadvertently not continuing metformin on discharge, Transitions of care, At discharge|GI adverse effects, GI side effects after discharge, Within 3 days of discharge|Mortality, Mortality as determined via chart search and follow up phone call, 30 +/- 3 days after discharge | Other: 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
Sponsor/Collaborators: Sponsor: University of Illinois at Chicago
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-01-21
Completion Date: 2026-06-30
Results First Posted:
Last Update Posted: 2025-02-27
Locations: University of Illinois at Chicago, Chicago, Illinois, 60612, United States
URL: https://clinicaltrials.gov/show/NCT06296836