A randomized, double-blind, placebo-controlled, dose-ranging pilot study of the efficacy and safety of GC811007 in subjects with type-2 diabetes mellitus and heart failure

ADDUCE: A randomized, double-blind, placebo-controlled, dose-ranging pilot study of the efficacy and safety of GC811007 in subjects with type-2 diabetes mellitus and heart failure: To assess safety and to determine whether treatment with GC811007 (400 and 1200 mg/day) improves exercise tolerance and indexes of cardiac structure and function

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000739819

Acronym

ADDUCE: Assessment of a Drug for Diabetes and heart failUre using Cardiopulmonary Exercise - (ADDUCE

Enrollment

Registered

2012-07-10

Start date

2004-07-13

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

A pilot study of subjects with type-2 diabetes mellitus and heart failure to determine whether treatment with two different doses of GC811007 improves exercise tolerance and indexes of cardiac structure and function; also to assess safety.

Interventions

Treatment with GC811007 (two treatment groups 400 and 1200 mg/day), supplied as multiples of 400mg capsules once per day over a six-month period, dose comparison versus placebo.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Men and women > 20 years of age with type-2 diabetes mellitus and heart failure; must complette two CPET tests at baseline

Exclusion criteria

Healthy patients; subjects younger than 20 years; inability to complete 2 CPET tests at Baseline

Outcome results