Apr 13: Ertugliflozin is PIII ready, with trials expected to begin later in 2013 [1]. 30/04/2013 13:14:53
Trial or other data
Apr 14: NCT02099110 is a PIII, randomized, double-blind, multicenter study of the combination of ertugliflozin + sitagliptin vs ertugliflozin and sitagliptin alone, in the treatment of 1250 subjects with T2DM with inadequate glycaemic control on metformin monotherapy. The primary outcomes are: change from baseline in HbA1C to week 26, and number who experience an adverse event (AE) and the number who discontinue because of an AE over 1 year. The study starts in Apr 14 and is due to complete May 16. [6] 10/04/2014 09:00:53
Jan 14: NCT02033889 is a PIII randomized, double-blind, placebo-controlled, 26-week multicenter study with a 78-week extension of ertugliflozin in 600 subjects with type 2 diabetes mellitus and inadequate glycemic control on metformin monotherapy. The primary outcomes are change from baseline in HbA1C at Week 26, number of participants experiencing an adverse event up to week 106 and number of participants discontinuing study treatment. The study starts Jan 14 and is due to complete Sep 17 (primary completion date Dec 15) [5]. 15/01/2014 21:04:37
Jan 14: NCT02036515 is a PIII, multicentre, randomized, double-blind, placebo-controlled trial of ertugliflozin in the treatment of 405 subjects with type 2 diabetes mellitus who have inadequate glycaemic control on metformin and sitaglIptin. The primary outcomes are change from baseline in HbA1C at Week 26, number of participants experiencing an adverse event up to week 54 and number of participants discontinuing study treatment. The study starts Mar 14 and is due to complete Apr 16 (primary completion date Sep 15) [5]. 15/01/2014 21:04:23
Dec 13: NCT01999218 is a PIII, multicentre, randomized, double-blind, active-comparator-controlled study of the addition of ertugliflozin (5 or 15mg/daily) vs glimepiride (up to 8mg daily) in 1230 subjects with T2DM who have inadequate glycaemic control on metformin. Open label sitagliptin will be allowed as rescue medication. The primary outcomes are: change from baseline in HbA1C at week 52; and number of participants experiencing an adverse event and discontinuing study treatment because of an AE up to week 106. The study starts Dec 13 and is due to complete Mar 17 [4]. 05/12/2013 08:54:35
Nov 13: NCT01986881 is a randomized, double-blind, placebo-controlled, study to assess cardiovascular outcomes following treatment with ertugliflozin in 3900 subjects with T2DM and established vascular disease. The primary outcome is time to first occurrence of any component of the composite endpoint of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The study starts Dec 13 and is due to complete Apr 20 [3]. 21/11/2013 15:50:44
Nov 13: NCT01986855 this study will eva luate efficacy and safety of ertugliflozin (5mg and 15mg) vs placebo in 468 participants with T2DM with Stage 3 Chronic Kidney Disease (CKD) who have inadequate glycemic control on background antihyperglycemic therapy. The 67 week study will comprise a 1-week Screening Period, a 10-week wash-off period from metformin, if needed, and a 2-week placebo run-in period, a 52-week double-blind treatment period, and a 14-day post-treatment follow-up period. The primary outcome is change from baseline in A1C at Week 26. The study starts Dec 13 and is due to complete Aug 16 [3]. 21/11/2013 15:50:30
Oct 13: NCT01958671 is a PIII, randomized, double-blind, placebo-controlled, 26-week multicentre study with a 26-week extension to eva luate the efficacy and safety of ertugliflozin monotherapy in the treatment of 450 subjects with T2DM and Inadequate glycaemic control despite diet and exercise. The primary outcome is change from baseline in HbA1c and the number of AEs and discontinuations. The study starts Oct 13 and is due to complete Mar 16 [2]. 11/10/2013 14:35:40
Apr 13: Merck (MSD) and Pfizer have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer’s ertugliflozin.including ertugliflozin-containing fixed-dose combinations with metformin and sitagliptin tablets [1] 30/04/2013 13:15:13
References
Available only to registered users
Category
BNF Category:
Other antidiabetics (06.01.02.03)
Pharmacology:
sodium glucose cotransporter (SGLT2) inhibitor
Epidemiology:
Estimated UK preva lence of diagnosed diabetes was 2.9 million people in 2011; 85% have T2DM and about 72% are receiving medication. It is thought a further 850,000 are undiagnosed.
