Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study
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|ClinicalTrials.gov Identifier: NCT00481429|
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : January 29, 2009
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?
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Rosiglitazone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Predictive Markers of Glitazone Efficacy in Diabetic Patients - Pilot Study|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
Active Comparator: 1
Rosiglitazone 4mg od, increased to 4mg bg at 4 weeks if HbA1C above 7%.
No Intervention: 2
Diet control +/- metformin
- 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 ]
- Variability in baseline levels of key biochemical markers in diabetic patients. [ Time Frame: 12 weeks ]
- Effect of treatment on a variety of other novel potential predictive biomarkers and markers of insulin sensitisation in diabetic patients. [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481429
|Cambridge, United Kingdom, CB2 2GG|
|London, United Kingdom, UB1 3HW|
|Imperial College London - Hammersmith Campus|
|London, United Kingdom, W12 ONN|
|Charing Cross Hospital|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Martin R Wilkins, MD FRCP||Imperial College London|