drugset / Trial / NCT01257334

Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

NCT01257334

Phase 3 Unknown 1390 enrolled Taipei Medical University WanFang Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control. Open-label arm: to estimate efficacy and safety of 25 mg BI 10773 in very poorly controlled patients (HbA1c \> 10%)

Timeline

Start
2010-09
Primary completion
2011-09
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 10 mg Oral
Subject Empagliflozin Small molecule 25 mg Oral