NDLI: Efficacy and safety of ipragliflozin in patients with type 2 diabetes inadequately controlled on metformin: a dose-finding study.

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Efficacy and safety of ipragliflozin in patients with type 2 diabetes inadequately controlled on metformin: a dose-finding study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Wilding, J. P. H. Ferrannini, E. Fonseca, V. A. Wilpshaar, W. Dhanjal, P. Houzer, A.
Spatial Coverage	United States Europe
Description	Country affiliation: United kingdom Author Affiliation: Wilding JP ( Department of Obesity and Endocrinology, Clinical Sciences Centre, University of Liverpool, University Hospital Aintree, Liverpool, UK. j.p.h.wilding@liv.ac.uk)
Abstract	AIMS: Ipragliflozin is a novel, selective inhibitor of sodium glucose co-transporter 2 (SGLT2 inhibitor) in clinical development for type 2 diabetes mellitus (T2DM) treatment. This study assessed the efficacy and safety of different doses of ipragliflozin. METHODS: In a 12-week, multicentre, double-blind, randomized, placebo-controlled, dose-finding study patients with inadequate glycaemic control on metformin monotherapy (≥1500 mg/day) were randomized to one of four ipragliflozin treatment groups (12.5, 50, 150 or 300 mg once daily) or placebo. Primary efficacy outcome was mean change from baseline in haemoglobin A1c (HbA1c) compared to placebo at week 12. Adverse events (AEs), vital signs and laboratory safety measurements were assessed. RESULTS: Ipragliflozin dose dependently decreased HbA1c from baseline to week 12 compared to placebo (-0.22, -0.34, -0.40 and -0.48% for ipragliflozin 12.5, 50, 150 and 300 mg, respectively). Decreases in body weight and blood pressure were observed for all ipragliflozin groups. AEs occurred in 39.7-51.4% of the ipragliflozin groups and 39.4% of placebo patients. Urinary tract infections (1.4-6.9 vs. 6.1%), genital infections (0-4.3 vs. 1.5%) and hypoglycaemia (0-5.9 vs. 3.0%) were similar in the ipragliflozin and placebo groups, respectively, without dose dependency. There were no clinically relevant effects on other safety measurements. CONCLUSIONS: Ipragliflozin treatment improved glycaemic control when added to metformin therapy and may be associated with weight loss and reductions in blood pressure compared to placebo. No safety or tolerability concerns were identified at any of the tested doses supporting the further development of ipragliflozin at ≥50 mg doses in T2DM patients.
File Format	HTM / HTML
ISSN	14628902
Issue Number	5
Volume Number	15
e-ISSN	14631326
Journal	Diabetes, Obesity and Metabolism
Language	English
Publisher	Wiley-Blackwell
Publisher Date	2013-05-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Metabolism Discipline Endocrinology Discipline Pharmacology Discipline Diabetology Blood Glucose Metabolism Diabetes Mellitus, Type 2 Blood Drug Therapy Glucosides Administration & Dosage Hemoglobin A, Glycosylated Hypoglycemic Agents Metformin Thiophenes Biological Markers Epidemiology Dose-response Relationship, Drug Double-blind Method Drug Administration Schedule Drug Therapy, Combination Europe Female Humans Male Middle Aged Time Factors Treatment Outcome United States Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Endocrinology, Diabetes and Metabolism Internal Medicine Endocrinology

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Efficacy and safety of ipragliflozin in patients with type 2 diabetes inadequately controlled on metformin: a dose-finding study.

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