Comparison of FDC Empagliflozin/Metformin Vs Monotherapy. Version 1.0

• Research type

  Research Study

• Full title

  A 24-week phase III randomized, double-blind, parallel group study to evaluate the efficacy and safety of twice daily oral administration of empagliflozin + metformin compared with the individual components of empagliflozin or metformin in drug naive patients with type II diabetes mellitus.

• IRAS ID

  94882

• Contact name

  Nell Wyatt

• Sponsor organisation

  Boehringer Ingelheim Ltd

• Eudract number

  2010-021375-92

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study will compare treatment of fixed dose combinations (FDC) of empagliflozin and metformin to treatment with single therapy of empagliflozin 10mg or 25mg or metformin 500mg or 1000mg alone. The study will assess if treatment with fixed dose combinations is superior in terms of glycaemic (blood glucose) control compared to treatment with monotherapy (single therapy) in patients with type 2 diabetes that have insufficient glycaemic control on diet and exercise. Assignment to either a FDC or single therapy will be randomly assigned and will be double-blind (patient and investigator will not know what medication is assigned). There is also an open-label part (patient and investigators know what medication is being given) for patients who do not meet the full criteria for the double-blind, randomisation part of this study (as described above). The open-label arm is for patients with very poor glycaemic control and will be given a FDC of empagliflozin 12.5mg metformin 1000mg. Open label arm will look at safety and efficacy of empagliflozin as an add-on to standard of care. This will be an exploratory arm with no planned formal hypothesis. Paitents in open-label arm will be able to receive rescue medication also. The study will be recruiting at a number of GP centres in England and Scotland from approximately November 2012 until approximately February 2014. Patients enrolled in the trial will attend a total of 8 clinic visits over a 28 week period. This includes 1 week screening, 2 week run-in period, 24 week randomisation (visits 3-7) and 1 week follow-up visit.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0349

• Date of REC Opinion

  3 Sep 2012

• REC opinion

  Further Information Favourable Opinion