Phase I/2 trial of Deferasirox in patients with type 2 diabetes

Phase 1

Withdrawn

• Conditions: Type 2 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616000330448
• Lead Sponsor: Westmead Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

T2D diagnosed within the last 10 years, with an HbA1c of 7.5%-10%, inclusive. The patients may be treated with diet and exercise or with metformin alone, at a stable dose for the preceding 3 months. After 8 weeks, if their glucose control is not improving, they will be allowed to start other hypoglycaemic medications.

Exclusion Criteria

Age <30 (less likely to be T2DM), or >75 years
BMI <25kg/m2, or <23kg/m2 if of South East Asian or Subcontinental Asian ethnicity
Body weight >120kg.
Elevated serum creatinine outside the normal range or eGFR <60ml/min
Anaemia, thrombocytopaenia, iron deficiency or known iron overload conditions
Low serum ferritin (<150ng/ml for men or <100ng/ml for women)
Any grade of known diabetic retinopathy above mild non-proliferative changes
Because of the reported low incidence of cataracts, all patients must have a diabetic eye screen within the preceding year and patients with cataracts will be excluded
Microalbuminuria or macroalbuminuria (confirmed on repeat testing), excluded due to the reported rare side effect of Fanconi syndrome
Significant proteinuria (confirmed on repeat testing). Defined as a urinary protein:creatinine ratio of >1mg/mg in a mid-stream sample
Unstable angina, congestive cardiac failure, stable angina with onset <500m of walking or claudication with onset distance <500m, all due to the small risk of inducing anaemia
Pregnancy, breast-feeding or lack of reliable contraception in women of child-bearing age
Known malignancy
Liver function tests >twice the upper limit of the normal reference range
Inability to give informed consent
Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator’s opinion makes it undesirable for the patient to participate in the study, or which would jeopardise compliance with the protocol.
Medical co-morbidities that have the potential to be exacerbated by or contra-indicate treatment with deferasirox

Study & Design

• Study Type: Interventional
• Study Design: Not specified