Response To Oral Agents in Diabetes (ROAD)- Pilot Study
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
This proposal is to fund a pilot study to assess feasibility and refine methodology for an
intended large Scotland wide study on Response to Oral Agents in Diabetes (ROAD). The study
will collect cohorts of patients who have carefully controlled standardised dose titration
and monitoring with an assessment of drug response and side effects over a 6 month period.
The primary aim will be to use these cohorts to investigate phenotypic and genotypic
(pharmacogenetic) determinants of response.
Drug naïve patients will be treated with Metformin. Patients who have failed on Metformin or
are intolerant of Metformin will be randomised to gliclazide, pioglitazone or sitagliptin.
With the ability to capture patient data beyond 6 months via data linkage we will monitor
time to treatment failure and therefore compare which of the 3 oral agents is the best
therapy to use after Metformin in a cost efficient and "real world" RCT.