Comparison of FDC Linagliptin/Pioglitazone Vs Monotherapy. Version 3.0

• Research type

  Research Study

• Full title

  A randomised, double-blind parallel group study to compare the efficacy and safety of initial combination therapy with linagliptin 5 mg + pioglitazone 15 mg, 30 mg, or 45 mg, vs. monotherapy with pioglitazone (15 mg, 30 mg, or 45 mg) or linagliptin 5 mg once daily for 30 weeks, followed by a 54 week blinded trial period on linagliptin 5 mg + pioglitazone 30 or 45 mg versus pioglitazone monotherapy 30 or 45 mg in type 2 diabetic patients with insufficient glycaemic control on diet and exercise

• IRAS ID

  53786

• Contact name

  John Reckless

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2008-008127-15

• ISRCTN Number

  n/a

• Research summary

  Part A of this study will compare treatment of fixed dose combinations (FDC) of the study drug linagliptin 5mg and pioglitazone 15mg, 30mg and 45mg, to treatment with linagliptin 5mg or pioglitazone 15mg, 30mg or 45mg alone. The study will assess if treatment with fixed dose combinations is superior in terms of glycaemic (blood glucose) control to treatment with monotherapy (single therapy) in patients with type 2 diabetes with insufficient glycaemic control on diet and exercise.Part B of the study will look at the maintenance of treatment effect and safety of the linagliptin/pioglitazone combination therapy (linagliptin 5mg and pioglitazone 30mg or 45mg) versus pioglitazone monotherapy (pioglitazone 30mg or 45mg)This study will be recruiting at a number of GP surgeries across Scotland and England from approximately October 2010 until November 2011. Patients enrolled in the trial will attend 14 study visits over an 88 to 97 week period. This will involve a Screening visit, Placebo run-in period of up to 2 weeks, 30 weeks Randomised period in Part A (visits 3 to 8), 54 weeks Randomised period in Part B (visits 9 to 13) and a Follow-up visit one week after completion of treatment.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/49

• Date of REC Opinion

  17 Sep 2010

• REC opinion

  Further Information Favourable Opinion