Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

Summary

* To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy. * To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy. * To evaluate the safety of HMR1964.

Timeline

Start

2003-12

Primary completion

—

Completion

—

Outcome

Met primary endpoint

paper Superiority of glulisine + OAD and glulisine monotherapy vs. OAD only was shown by differences in adjusted mean HbA(1c) change from baseline values of -1.46% (p < 0.0001) and -0.64% (p < 0.0001) respectively. PMID 19614946 ↗

Publications

• Results Kawamori R, Iwamoto Y, Kadowaki T, Iwasaki M, Kim SW, Woo JT, Baik SH, Yoon KH. Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Sep;11(9):900-9. doi: 10.1111/j.1463-1326.2009.01088.x. Epub 2009 Jul 13.

Drugs

Indications