Effects of Metformin in Heart Failure Patients

November 20, 2018 updated by: Maya Guglin

Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are admitted for HF, leads to reduced insulin requirements, as measured in units of insulin, with no negative impact on patient safety.

This is a single center, prospective trial. Subjects will be randomized to initiate metformin (starting dose 500mg orally once daily up to a maximum dose of 2,500mg daily) OR be placed on insulin products for management of their type 2 diabetes mellitus.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Because of the state of insulin resistance in heart failure (HF), metformin, with its ability to sensitize tissues to insulin, seems to be an ideal agent for managing type 2 diabetes mellitus (DM) in HF. It reduces the concentration of glucose in blood by enhancing insulin sensitivity, inducing greater peripheral uptake of glucose, and decreasing hepatic glucose output. However, according to the package insert, it is contraindicated in all patients with HF requiring pharmacologic treatment because of increased risk of lactic acidosis. The FDA has now de-escalated this contraindication to a warning as the evidence is lacking regarding an increased risk of lactic acidosis in patients with type 2 DM and HF who take metformin.

Hypothesis: In patients, who have diabetes type 2, are treated with metformin, and are admitted for HF, metformin leads to reduced insulin requirements, as measured in units of insulin, with no negative impact on patient safety.

Primary Objective: To test the hypothesis that continuing a patient's home metformin for diabetes management while admitted to UK hospital will result in decreased utilization of insulin as denoted by total units given.

Secondary Objectives: To test the hypothesis that administering metformin in HF patients admitted to UK Hospital:

  1. Results in similar glycemic control (targeting a blood glucose < 200mg/dL) when compared with placebo along on the basis of basic metabolic panel glucose values. Both groups may receive conventional inpatient hyperglycemia management with insulin products
  2. Reduces drug and laboratory costs
  3. Reduces hospital length of stay
  4. Does not result in hypoglycemia (blood glucose < 60 mg/dL)
  5. Reduced discharge medication errors related to diabetic medications
  6. No observed increase in metabolic acidosis due to elevated lactate levels
  7. Does not impact heart failure status (as indicated by trending NT-pro BNP levels)

Both the diagnosis and clinical management of patients with heart failure and type 2 diabetes mellitus will be guaranteed by the application of standard guidelines internationally recognized. All patients admitted to the Medicine / Cardiology Advanced Heart Failure at UK Hospital will be evaluated for inclusion and exclusion criteria. Based on our power analysis we plan to enroll 100 subjects total. Subjects will be enrolled from January 1, 2016 - December 31, 2018 until 120 patients are enrolled, estimated study time frame is two years.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients > / = 18 years of age
  2. Admitted to the Medicine / Cardiology Advanced Heart Failure at UK Hospital
  3. Carry a diagnosis of heart failure with or without preserved ejection fraction
  4. Carry a diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

  1. Patients <18 years of age
  2. Prisoners
  3. Terminal state
  4. Known adverse reaction or hypersensitivity to metformin administration
  5. Pregnancy
  6. Pathological conditions in which metformin administration is clinically contraindicated (Patients with acute or chronic metabolic acidosis, serum creatinine > 1.4 mg/dL in females, serum creatinine > 1.5 mg/dL in males)
  7. Patients with acute cardiovascular collapse, acute myocardial infarction, septicemia
  8. Patients carrying a diagnosis of type 1 diabetes mellitus
  9. Patients admitted with diabetic ketoacidosis or hyperosmotic hyperosmolar state.
  10. Patients who experience diabetic ketoacidosis or hyperosmotic hyperosmolar state at any point during their hospital admission.
  11. Patients admitted with a subcutaneous insulin pump
  12. Patients who, at the discretion of the Medicine / Cardiology Advanced Heart Failure service, required an endocrinology consult during their hospitalization where the endocrine consult service is opposed to utilizing metformin in a particular patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Metformin
Continue Metformin while admitted to hospital
Drug: Metformin
Treatment/continuation of metformin therapy during admission
Other Names:
  • no other names
Other: Subcutaneous (sliding scale) Insulin
Discontinue Metformin upon admission and be placed on sliding scale subcutaneous insulin treatment while admitted to hospital
Drug: Subcutaneous (sliding scale) Insulin
Discontinue Metformin and be placed on subcutaneous sliding scale insulin during admission
Other Names:
  • eg. Humulin, Lantus, Novalin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Units of Insulin used
Time Frame: from time of hospital admission to hospital discharge, up to one year
doses and amounts on insulin needed
from time of hospital admission to hospital discharge, up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose levels
Time Frame: from time of hospital admission to hospital discharge, up to one year
patient's glycemic control will be evaluated based on blood glucose levels
from time of hospital admission to hospital discharge, up to one year
Length of stay
Time Frame: time from hospital admission to hospital discharge, up to one year
time from hospital admission to hospital discharge, up to one year
Lactate levels, mmol/L
Time Frame: from time of hospital admission to hospital discharge, up to one year
from time of hospital admission to hospital discharge, up to one year
pro-BNP levels, pg/mL
Time Frame: from time of hospital admission to hospital discharge, up to one year
from time of hospital admission to hospital discharge, up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maya Guglin

Investigators

  • Principal Investigator: Maya Guglin, MD, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

September 10, 2018

Study Completion (Actual)

September 10, 2018

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Actual)

November 23, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0797-F6A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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