Effects of Metformin in Heart Failure Patients

NCT02694289 | Withdrawn DMC

• 1 other identifier: 15-0797-F6A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Units of Insulin used

  doses and amounts on insulin needed

  from time of hospital admission to hospital discharge, up to one year

Secondary Outcomes (4)

• Blood glucose levels

  from time of hospital admission to hospital discharge, up to one year

• Length of stay

  time from hospital admission to hospital discharge, up to one year

• Lactate levels, mmol/L

  from time of hospital admission to hospital discharge, up to one year

• pro-BNP levels, pg/mL

  from time of hospital admission to hospital discharge, up to one year

Study Arms (2)

Metformin

OTHER

Continue Metformin while admitted to hospital

Drug: Metformin

Subcutaneous (sliding scale) Insulin

OTHER

Discontinue Metformin upon admission and be placed on sliding scale subcutaneous insulin treatment while admitted to hospital

Drug: Subcutaneous (sliding scale) Insulin

Interventions

Metformin DRUG

Treatment/continuation of metformin therapy during admission

Also known as: no other names

Metformin

Subcutaneous (sliding scale) Insulin DRUG

Discontinue Metformin and be placed on subcutaneous sliding scale insulin during admission

Also known as: eg. Humulin, Lantus, Novalin

Subcutaneous (sliding scale) Insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients \<18 years of age
• Prisoners
• Terminal state
• Known adverse reaction or hypersensitivity to metformin administration
• Pregnancy
• 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)
• Patients with acute cardiovascular collapse, acute myocardial infarction, septicemia
• Patients carrying a diagnosis of type 1 diabetes mellitus
• Patients admitted with diabetic ketoacidosis or hyperosmotic hyperosmolar state.
• Patients who experience diabetic ketoacidosis or hyperosmotic hyperosmolar state at any point during their hospital admission.
• Patients admitted with a subcutaneous insulin pump
• 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

Sponsors & Collaborators

• Maya Guglin: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Injections, Subcutaneous; Insulin; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Maya Guglin, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 29, 2016
• Study Start: November 1, 2016
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share