Combination well-tolerated in patients with type 2 diabetes….
Ipragliflozin is an oral medication in development by Astellas Pharma for the treatment of type 2 diabetes. A novel selective sodium glucose co-transporter-2 (SGLT-2) inhibitor, ipragliflozin works similarly to the first in class marketed SGLT-2 inhibitor drug canagliflozin by increasing urinary excretion of glucose.
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A recent RCT set out to determine the safety and tolerability of ipragliflozin in combination with metformin on lowering glucose in patients with type 2 diabetes. The study also looked at the pharmacokinetic (PK) properties of metformin.
Patients with type 2 diabetes (N=36) already receiving stable metformin treatment (doses of 850, 1000, or 1500 mg BID) were randomized to receive ipragliflozin 300mg once daily (n=18) or matching placebo (n=18). Researchers assessed safety, adverse events, laboratory values, and vital signs during the treatment period. Additionally, PK parameters were assessed via geometric mean ratio and AUC for the combination treatment group versus the metformin treatment alone on day 1.
Researchers found an overall low adverse event rate, with 15 AEs observed in the ipragliflozin treatment group in 38.9% of patients, and 19 AEs observed in the placebo group in 44.4% of patients. There were no episodes of hypoglycemia reported in either group. With regards to PK analysis, researchers found geometric mean ratios for Cmax and AUC(0-10) of metformin + ipragliflozin and metformin alone to be 1.11 and 1.18, respectively.
Authors concluded that 14-day combination treatment with metformin + ipragliflozin is well tolerated with few AEs in patients with type 2 diabetes. They also noted that no major PK changes resulted from the addition of ipragliflozin 300mg daily to metformin therapy.
- Ipragliflozin is an oral medication in development for the treatment of type 2 diabetes that works by increasing urinary excretion of glucose.
- Combination treatment with metformin + ipragliflozin is well tolerated with few AEs in patients with type 2 diabetes.
- No clinically relevant PK changes resulted from the addition of ipragliflozin 300mg daily to metformin therapy.
Diabetes/Metabolism Research & Reviews 2014 [Veltkamp, S.A. et al. Combination Treatment With Ipragliflozin and Metformin: A Randomized, Double-Blind, Placebo-Controlled Study in Patients With Type-2 Diabetes Mellitus. Clinical Therapeutics. 2012;34(8):1761-1770.]