Repeat dose study in Type 2 Diabetics with an SGTL-1 inhibitor

• Research type

  Research Study

• Full title

  A 2-Part trial including a randomized, double-blind, double dummy, 6-day repeat-dose, parallel-group study in subjects with type 2 diabetes mellitus, to assess the safety and tolerability of GSK1614235 when administered in doses up to 40mg BID as compared to placebo and sitagliptin 100mg QD and a randomized, double-blind, single-dose, crossover study in healthy volunteers to assess safety and tolerability differences that might occur when single doses of GSK1614235 are administered to healthy subjects immediately before and 30 min after meals.

• IRAS ID

  25901

• Contact name

  Antonella Napolitano

• Eudract number

  2009-012415-17

• ISRCTN Number

  NA

• Research summary

  The current trial is designed in two parts, Part A will evaluate repeat doses of GSK1614235 in Type 2 Diabetes Mellitus (T2DM) patients and Part B will evaluate the time of dosing relative to meals with single dose administration in healthy volunteers. Part A will be conducted in the UK and other centres in the EU and Part B will be carried out in the US. GSK1614235 is being investigated as a new mechanism for treating Type 2 Diabetes by controlling glucose levels in blood after meals. In part A, the aim of the study is to test whether GSK1614235 can prevent the occurrence of high blood glucose levels after a meal (characteristic in Type 2 Diabetes) and to even out the blood glucose levels between. The study will provide information on the safety and tolerability of GSK1614235, its blood levels of drug, and how these affect blood markers of glucose and diabetes control. The subjects in this study will receive dietary and activity instructions and the study will determine both the maximum tolerated dose and minimally effective dose of GSK1614235 in subjects with T2DM. The repeat dose component of the study will assess early clinical safety and tolerability the drug.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  09/H0605/82

• Date of REC Opinion

  13 Aug 2009

• REC opinion

  Further Information Favourable Opinion