Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To conduct a pilot study to evaluate the feasibility of a large randomized controlled trial (RCT) of metformin in patients with heart failure and type 2 diabetes and to generate initial morbidity and mortality estimates in this patient population. The primary hypothesis is that subjects with heart failure and type 2 diabetes who receive metformin will have a significant reduction in the combined endpoint of all-cause mortality and all-cause hospitalization as compared to subjects who receive placebo therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Metformin

Criteria

Inclusion Criteria:

• All subjects with physician-diagnosed symptomatic heart failure (NYHA class I, II, III, IV) and type 2 diabetes.

A diagnosis of type 2 diabetes defined as:

• a previous physician diagnosis of type 2 diabetes as documented in the subject's clinical record or;

• receiving oral antihyperglycemic agents or;

• a new diagnosis of type 2 diabetes during the visit within the heart failure clinic or hospital based on a fasting blood glucose ≥7.0 mmol/L or random blood glucose ≥11.1 mmol/L accompanied by acute metabolic decompensation or 2 hour plasma glucose in a 75 gram oral glucose tolerance test ≥11.1 mmol/L.

Exclusion Criteria:

• subjects currently receiving greater than 1500 mg of metformin therapy per day

• subjects who are unwilling to change their antidiabetic regimens;

• subjects receiving insulin therapy;

• serum creatinine ≥ 180 μmol/L;

• A1c < 7.0 percent;

• inability to communicate (language barrier);

• dementia/mental illness;

• age < 18 years;

• subjects unwilling to complete self-monitoring of serum blood sugars during the trial period.

• those participating in another heart failure or diabetes clinical trial involving medication;

• severe comorbidities or foreshortened life expectancy;

• subjects who do not provide written informed consent to participate.