None listed
Conditions
Brief summary
This is a two-period (4 months each), two-treatment, randomised crossover study of a DPP4 inhibitor (vildagliptin), and thiazolidinedione (pioglitazone) as second or third line oral therapy in patients with type 2 diabetes who have suboptimal glycaemic control on therapy with either metformin alone, or metformin and a sulphonylurea. The study aims to determine whether baseline characteristics such as ethnicity, genotype, obesity, lipids impacts on the glucose lowering response achieved by either of these two oral medications used to treat Type 2 diabetes.
Interventions
Crossover study of two medications:
Vildagliptin 50mg oral tablet, once daily for 4 months
Pioglitazone 30mg oral tablet, once daily for 4 months
In random order without any washout period.
Adherence monitored by bottle returns and participant recall.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Clinical diagnosis of Type 2 diabetes • Diabetes duration greater than or equal to 12 months • Age between 18 and 80 years inclusive • Currently treated with metformin and/or sulphonylureas and no past or current treatment with a DPP4-inhibitor or a thiazolidinedione. • No treatment with insulin in the last 3 months • Diabetes duration greater than or equal to 12months • No change in diabetes treatment (new treatments or dose change) within previous 3 months • HbA1c greater than 58mmol/mol (7.5%) and less than or equal to 110mmol/mol (12.2%) – confirmed at screening • Able and willing to give informed consent
Exclusion criteria
• Changes in glucose-lowering therapy or dose within last 3 months • Insulin treated within the last 3 months • Treatment with study drugs in the past • Currently treated with oral corticosteroids • Currently treated with rifampicin, gemfibrozil, phenytoin or carbamazepine • Active infection (any infection requiring antibiotics at present) • Active liver disease (AST or ALT over 3 times upper limit of normal) • Heart failure greater than NYHA class 2 • History of bladder carcinoma • Current/ongoing investigation for macroscopic haematuria • History of Diabetic Ketoacidosis • History of pancreatitis • Pregnant, breastfeeding or planning a pregnancy over the study period • Concurrent Participation on another Clinical Trial of an Investigational Medicinal Product, where the IMP is currently being taken, or without sufficient washout period* and without consultation with the CTIMP research team. • Unable or unwilling to give informed consent * Sufficient washout period equals five times the half-life of the IMP / potential IMP if involving a placebo / longest half-life if a trial includes more than one drug.
Outcome results
None listed