Status:
TERMINATED
Patients With Heart Failure ANd Type 2 Diabetes Treated With Placebo Or Metformin (PHANTOM) Pilot Study
Lead Sponsor:
University of Alberta
Conditions:
Diabetes Mellitus, Type 2
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Background: Heart failure (HF) is a common complication of type 2 diabetes mellitus. There are limited treatment options for patients with HF and diabetes. Although metformin is considered a safe and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00325910
Start Date
May 1 2006
End Date
May 1 2007
Last Update
May 14 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Misericordia Hospital
Edmonton, Alberta, Canada, T5R 4H5
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7