At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Response To Oral Agents in Diabetes (ROAD)- Pilot Study
In Brief
A Phase 4 clinical trial evaluating Gliclazide MR, Sitagliptin, and 2 other interventions for Diabetes Mellitus, Type 2. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
30mg daily increased to 60mg if HbA1c \> 7% at 3 months
Sitagliptin 100mg daily for 6 months
Pioglitazone 30mg daily , increased to 45mg daily if HbA1c \>7% at 3 months. 6 months duration
Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment