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

This study has been terminated.
(Insufficient study participants)
Information provided by:
University of Alberta Identifier:
First received: May 12, 2006
Last updated: May 12, 2008
Last verified: May 2008

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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Heart Failure, Congestive
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study

Resource links provided by NLM:

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Combined endpoint of all cause mortality and all cause hospitalization at 6 months

Secondary Outcome Measures:
  • Individual components of the primary outcome (ie death or hospitalization)
  • Change in A1c
  • Change in 6 minute walk
  • Change in Health Related Quality of Life
  • Development of Lactic Acidosis

Estimated Enrollment: 100
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00325910

Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Misericordia Hospital
Edmonton, Alberta, Canada, T5R 4H5
Sponsors and Collaborators
University of Alberta
Principal Investigator: Jeffrey A Johnson, PhD University Of Alberta, Alberta, Canada
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00325910     History of Changes
Other Study ID Numbers: Approval J-2865, Ethics 6002
Study First Received: May 12, 2006
Last Updated: May 12, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Heart Failure

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 20, 2014