Metformin against gliclazide in patients with diabetes and heart failure

Metformin against gliclazide in patients with diabetes and heart failure: a randomised open label study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN05434670

Enrollment

Registered

2010-04-29

Start date

2006-10-24

Completion date

Unknown

Last updated

2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular

Interventions

Follow-up: Patients will be reviewed each month for symptom assessment using the standardised symptom questionnaire and EQ5-D. Patients will also undergo physical examination including

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diabetes on oral hypoglycaemic agents (OHGA) 2. Heart failure 3. Male and female, lower age limit of 18 years

Exclusion criteria

Exclusion criteria: 1. Diabetes on insulin 2. No left ventricular function (LVF)

Design outcomes

Primary

Measure	Time frame
Difference in left ventricular end-systolic volume between patients randomised to metformin compared to gliclazide at 8 months	—

Secondary

Measure	Time frame
Differences between the two groups in serum NT-pro BNP levels in: 1. Time to recovery of LV function after dobutamine stress 2. Insulin mediated flow reserve quantified by contrast enhanced ultrasound and markers of endothelial function 3. Average symptom score of all monthly follow-ups, which avoids undue emphasis being placed on a single time-point (patients who are withdrawn for worsening heart failure or who die will be assigned worst rank for symptom assessment at all subsequent time-points)	—

Measure

Time frame

Differences between the two groups in serum NT-pro BNP levels in: 1. Time to recovery of LV function after dobutamine stress 2. Insulin mediated flow reserve quantified by contrast enhanced ultrasound and markers of endothelial function 3. Average symptom score of all monthly follow-ups, which avoids undue emphasis being placed on a single time-point (patients who are withdrawn for worsening heart failure or who die will be assigned worst rank for symptom assessment at all subsequent time-points)

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026