Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
A cluster of biochemical measurements (biomarkers) predict which diabetic patients will respond to treatment with a therapeutic dose of rosiglitazone over a 12 week treatment period.
The purpose of this study is to assess the predictive value of the biomarkers in diabetic patients treated with a full dose of a thiazolidinedione (eg 4mg bid rosiglitazone) for 12 weeks.
Specifically - the questions asked are:
- Do baseline measurements of a selected panel of biomarkers predict the patients' response to rosiglitazone over 12 weeks?
- How does the panel of biomarkers change over that 12 week treatment period?
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Evaluation of Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study|
- The performance of baseline biochemical biomarkers in plasma and urine in distinguishing patients who respond to rosiglitazone from those that do not, as classified by a change in HbA1C at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Variability in baseline levels of key biochemical markers in diabetic patients. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Effect of treatment on a variety of other novel potential predictive biomarkers and markers of insulin sensitisation in diabetic patients. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.
No Intervention: 2
Diet control +/- metformin
Rosiglitazone (Avandia) is a medicine used to treat type 2 diabetes. It works by increasing the sensitivity of body tissues to insulin.
This pilot study will examine the possibility that baseline biochemistry might predict the response to rosiglitazone. The study will be conducted in males and the biomarkers of interest measured by specific assays. In addition, since the biomarkers to be measured come from body fat, interpretation of the data would be facilitated by accurate measurements of changes in body fat mass during treatment and these data can be obtained from Echo-MRI scans.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481429
|Cambridge, United Kingdom, CB2 2GG|
|Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|London, United Kingdom, UB1 3HW|
|Imperial College London - Hammersmith Campus|
|London, United Kingdom, W12 ONN|
|Principal Investigator:||Martin R Wilkins, MD FRCP||Imperial College London|