The effect of sodium-glucose transport protein 2 inhibitor and fibrate therapies, alone and in combination, on the serum uric acid concentration in hyperuricaemic people with type 2 diabetes

Phase 4

• Conditions: Type 2 diabetes; Hyperuricaemia; Metabolic and Endocrine - Diabetes; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12621000829819
• Lead Sponsor: Timothy Davis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-29
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•Type 2 diabetes diagnosed at least 3 months previously and treated with stable oral blood glucose lowering therapies
•Age between 18 and 70 years apart from women of child-bearing age who will be excluded.
•Body mass index between 20 and 40 kg/m²
•Glycated haemoglobin >6.5% and <9.0%
•Hyperuricaemia (serum uric acid above the upper limit of the laboratory reference range i.e. greater than to equal to 0.42 mmol/L)
• No current therapy with either an SGLT2i or a fibrate, or allopurinol or febuxostat
•No history of intolerance or adverse effects with past use of an SGLT2i or a fibrate
•No contraindications to SGLT2i or fibrate use including renal impairment (eGFR <45 mL/min), past history of recurrent genitourinary infections and/or symptomatic postural hypotension
•Stable doses of any medications (such as aspirin and thiazide diuretics) known to influence serum uric acid concentrations
•Stable alcohol intake of <3 standard drinks/day
•No recent history of smoking
•No significant co-morbidity such as cancer or mental health issues that would affect the ability to follow a normal lifestyle and take regular medications including allocated
•Ability to provide written informed consent and to attend all scheduled study assessments

Exclusion Criteria

•Type 1 or other non-Type 2 forms of diabetes
•Diagnosed within the last 3 months
•Recent changes in oral blood glucose lowering therapies
•Age lower than 18 years and greater than 70 years
•Women of child-bearing age
•Body mass index below 20 and greater than40 kg/m²
•Glycated haemoglobin <6.5% and >9.0%
•Normal serum uric acid (below the upper limit of the laboratory reference range or <0.42 mmol/L)
•Current therapy with either an SGLT2i or a fibrate, or allopurinol or febuxostat
•A history of intolerance or adverse effects with past use of an SGLT2i or a fibrate
•Contraindications to SGLT2i or fibrate use including renal impairment (eGFR <45 mL/min), past history of recurrent genitourinary infections and/or symptomatic postural hypotension
•Unstable doses of any medications (such as aspirin and thiazide diuretics) known to influence serum uric acid concentrations
•Alcohol intake of >3 standard drinks/day
•Recent smoking
•Significant co-morbidity such as cancer or mental health issues that would affect the ability to follow a normal lifestyle and take regular medications including allocated
•Inability to provide written informed consent and to attend all scheduled study assessments

Study & Design

• Study Type: Interventional
• Study Design: Not specified