Empagliflozin for type 2 diabetes mellitus - National Horizon ...

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April 2012 Efficacy and safety Trial NCT01177813, 2009- 016243-20, 1245.20; empagliflozin vs placebo vs sitagliptin; phase III. NCT01159600, 2009- 016258-41, 1245.23; empagliflozin vs placebo, both with metformin alone or in combination with a sulfonylurea; phase III. Boehringer Ingelheim Pharmaceuticals. Complete but unpublished. . NCT01368081, 1245.52; empagliflozin with an oral antidiabetic drug vs metformin; phase III. Sponsor Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals. Pharmaceuticals. Status Complete but unpublished. Ongoing. Source of information Trial registry 1 . Trial registry 22 23 Trial registry Location EU, USA, Canada, India, EU, USA, Canada and Japan. China and Japan. other countries. Design Randomised, active- and Randomised, placebo- Randomised, active- placebo-controlled. controlled.controlled. Participants n=986 (planned); adults; n=1,504; adults; type 2 n=1,122 (planned), 20 years and schedule type 2 diabetes mellitus; diabetes mellitus; and older; type 2 diabetes drug naive; HbA1c ≥7% insufficient glycaemic mellitus; pre-treated with an and ≤10%. control; pre-treatment oral anti-diabetic drug; Randomised to with metformin or HbA1c ≥7% and ≤10%. empagliflozin, 10mg or metformin with a Randomised to 25mg; placebo; sulfonylurea unchanged empagliflozin, 10mg or sitagliptin, 100mg; or for 12 weeks prior to 25mg oral once daily; or empagliflozin open-label, randomisation; HbA1c metformin, 500-2,250mg, 25mg. All administered ≥7% and ≤11%. oral daily. orally once daily. Randomised to empagliflozin, 10mg or 25mg; or empagliflozin open-label 25mg; or placebo. All administered orally once daily in combination with metformin ≥1,500mg daily or metformin with a sulfonylurea, administered at least half of the maximum recommended dose. Follow-up Active treatment period Active treatment period Active-treatment period 52 24 weeks. 24 weeks. weeks. Primary HbA1c. HbA1c. Adverse events (AEs); outcome hypoglycaemic events; protocol specified significant AEs; cardiovascular events; change in BP; change in laboratory values. Secondary Body weight; systolic and Body weight; mean HbA1c. outcomes diastolic blood pressure change in daily plasma (BP). glucose; target response (HbA1c
April 2012 Expected reporting date Previosuly reported as Mar 2012. Trial NCT01210001, 2009- 016154-40, 1245.19; empagliflozin vs placebo, both with pioglitazone alone or with metformin; phase III. (decrease in HbA1c by ≥0.5%); fasting plasma glucose (FPG); waist circumference; BP; composite endpoint of decrease in HbA1c by ≥0.5%, decrease in systolic BP by ≥3mmHg and decrease in body weight by >2%. Previously reported as Feb 2012. NCT01167881, 2009- 016244-39, 1245.28; empagliflozin vs glimepiride, both with metformin; phase III. Estimated study completion date, Mar 2013. NCT01289990, 2010- 022718-17, 1245.31; empagliflozin vs placebo, both with sitagliptin alone or with different background therapies; phase III Sponsor Boehringer Ingelheim Boehringer Ingelheim extension. Boehringer Ingelheim Pharmaceuticals. Pharmaceuticals. Pharmaceuticals. Status Ongoing. Ongoing. Ongoing. Source of information Trial registry 24 . 25 Trial registry . 26 Trial registry . Location EU, USA, Canada and EU (inc UK), USA, EU, USA, Canada and other other countries. Canada and other countries. countries. Design Randomised, placebo- Randomised, active- Non-randomised, active- and controlled.controlled. placebo-controlled. Participants n=468 (planned); adults; n=1,400; adults; type 2 n=1,920 (planned); adults; and schedule type 2 diabetes mellitus; diabetes mellitus; pre- type 2 diabetes mellitus; insufficient glycaemic treated with metformin 12 completed trials control; pre-treatment weeks prior to NCT01210001, with pioglitazone or randomisation; HbA1c NCT01177813, pioglitazone with ≥7% and ≤10%. NCT01159600. metformin unchanged for Randomised to Empagliflozin 10mg, 25mg; 12 weeks prior to empagliflozin 25mg; or or placebo, all oral once randomisation; HbA1c glimepiride 1-4mg, both daily, each arm alone or in ≥7% and ≤10%. oral once daily with combination with Randomised to metformin ≥1,500mg pioglitazone, metformin, empagliflozin, 10mg or daily. metformin and sulphonlurea, 25mg; or placebo. All or sitagliptin monotherapy administered orally once daily in combination with pioglitazone ≥30mg daily, alone or with metformin ≥1,500mg daily, unchanged throughout trial. 100mg, oral once daily. Follow-up Active treatment period Active treatment period Active treatment period 24 weeks. 104 weeks. minimum of 76 weeks. Primary HbA1c. HbA1c. Safety; tolerability; AEs; outcome changes in albumin/creatinine ratio; use of rescue therapy. 5
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