Torrent AGE breaker in CHF and diabetes or impaired glucose tolerance

• Research type

  Research Study

• Full title

  Safety and efficacy of TRC4186 in the treatment of stable heart failure associated with HbA1c = 6.5% or type 2 diabetes receiving oral hypoglycaemic therapy (with or without additional insulin) as an add-on to conventional treatment for heart failure.

• IRAS ID

  29037

• Sponsor organisation

  Torrent Pharma GmbH

• Eudract number

  2008-006237-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a Phase II clinical trial to investigate the safety and efficacy of adding TRC4186 to existing, guideline-indicated treatments for stable, chronic heart failure in patients who have evidence of impaired glucose metabolism as evidenced either by a glycated haemoglobin (HbA1c) exceeding 6.5% or treatment with oral hypoglycaemic therapy (with or without additional insulin) for type 2 (late onset, non-insulin dependent) diabetes. The duration of the study from a single patient perspective is 48 weeks. The study from first patient in to last patient out will be about 3 years. Enrolment is complete and is due to finish in early 2013

• REC name

  North East - York Research Ethics Committee

• REC reference

  09/H0903/44

• Date of REC Opinion

  21 Oct 2009

• REC opinion

  Further Information Favourable Opinion