Phase 4
Completed N=29
Response To Oral Agents in Diabetes (ROAD)- Pilot Study
Source: ClinicalTrials.gov NCT00780715 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: HbA1c Change — -0.42; -0.58; -1.04; -1.59 absolute change in %HbA1c
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change |
-0.42; -0.58; -1.04; -1.59 | — |
Eligibility Criteria
Inclusion Criteria
- Cohort 1 - metformin treatment
- Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
- GP considers adequate diet and lifestyle advice given
- Age >35 and 35
- White European
- HbA1c >7% & =50 ml/min
- ALT 35 and 35
- White European
- HbA1c >7% & =50 ml/min
- ALT 9% or 2.5*ULN
- Alcohol consumption in excess of 50 units per week
- Pregnancy, lactation or a female planning to conceive within the study period
- Any other significant medical reason for exclusion as determined by the investigator
- Cohort 2
- Type 1 diabetes
- HbA1c >9% or 2.5*ULN
- Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
- Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
- Previous diagnosis of osteoporosis
- Pregnancy, lactation or a female planning to conceive within the study period
- Any other significant medical reason for exclusion as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT00780715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.