NCT00325910

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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 14, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

May 12, 2006

Last Update Submit

May 12, 2008

Conditions

Diabetes Mellitus, Type 2Heart Failure, Congestive

Keywords

DiabetesHeart FailureMortalityHospitalizationFeasability

Outcome Measures

Primary Outcomes (1)

  • Combined endpoint of all cause mortality and all cause hospitalization at 6 months

Secondary Outcomes (5)

  • 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

Interventions

MetforminDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Misericordia Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

  • Eurich DT, Majumdar SR, McAlister FA, Tsuyuki RT, Johnson JA. Improved clinical outcomes associated with metformin in patients with diabetes and heart failure. Diabetes Care. 2005 Oct;28(10):2345-51. doi: 10.2337/diacare.28.10.2345.

    PMID: 16186261BACKGROUND

  • Eurich DT, Tsuyuki RT, Majumdar SR, McAlister FA, Lewanczuk R, Shibata MC, Johnson JA. Metformin treatment in diabetes and heart failure: when academic equipoise meets clinical reality. Trials. 2009 Feb 9;10:12. doi: 10.1186/1745-6215-10-12.

    PMID: 19203392DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Heart FailureDiabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Jeffrey A Johnson, PhD

    University Of Alberta, Alberta, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

May 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 14, 2008

Record last verified: 2008-05

Locations

CA(2)