Assessing Bladder Cancer Risk in Type 2 Diabetes Clinical Trials: the Dapagliflozin Drug Development Program as a 'Case Study'.

ABSTRACT:

Introduction

Dapagliflozin, a sodium-glucose co-transporter 2 inhibitor, decreases plasma glucose levels by suppressing renal glucose reabsorption and increasing urinary glucose excretion. Previously published pre-clinical data suggest that dapagliflozin lacks carcinogenic potential. This article reviews data on bladder cancer with dapagliflozin to illustrate the challenges in assessing bladder cancer in drug development programs in patients with type 2 diabetes mellitus (T2DM).

Methods

Clinical cases of bladder cancer were analyzed in a pooled population of >9000 patients in 21 phase 2b/3 dapagliflozin clinical trials of up to 208 weeks' duration.

Results

In the 21-study pool, demographic and baseline characteristics were generally consistent between dapagliflozin an

SUBMITTER: Ptaszynska A 

PROVIDER: S-EPMC4575305 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature