Type 2 Diabetes Clinical Trial
Official title:
MASTERMIND - Understanding Individual Variation in Treatment Response in Type 2
Response to treatment in Type 2 Diabetes is highly variable; the same medicine may have
little effect in one person but a large effect in another. Understanding mechanisms of
altered response to treatment could aid treatment selection and assist the design of new
medications with lower nonresponse rates.
This study will examine the physiological mechanisms and potential clinical/biomarker
predictors of altered response to sulphonylurea and DPPIV inhibitor glucose lowering
medication and answer fundamental methodological questions for the future study of variation
in treatment response in Type 2 Diabetes. Participants will withdraw sulphonylurea therapy
for up to 2 weeks with assessment of baseline characteristics and glycaemic response.
Participants will then enter an optional extension where they receive sulphonylurea or DPPIV
inhibitor therapy in crossover fashion.
Participants will withdraw sulphonylurea therapy for up to 2 weeks (part 1) followed by an
optional cross-over extension (part 2)where they are randomized to 4 weeks of treatment with
Gliclazide (DPP-IV thera) or Sitagliptin (sulphonylurea), followed by 4 weeks of the second
treatment with a 2 week wash-out period in between.
Part 1 will allow assessment of response rates to long standing sulphonylurea treatment in
clinical practice and potential predictors of this, as well as whether a very brief period (1
week) of treatment withdrawal is a valid assessment of an individual's response to therapy.
Part 2 will allow comparison of the approach in part one with response to the same treatment
in a trial setting and will allow assessment on whether response is consistent across
therapies with different mechanisms of action.
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