China-based drug development company Hua Medicine has reportedly declared positive results from a clinical trial called HMM0112. For the uninitiated, HMM0112 is a Phase I clinical trial that is conducted in the U.S., on patients having Type 2 Diabetes with not well-controlled blood glucose levels. The trial is conducted when these patients are on DPP-4 inhibitors, SGLT-2 inhibitors, or on metformin – either all by themselves, or in combination treatment.
The HMM0112 basically aims to investigate the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics of empagliflozin (a SGLT-2 inhibitor) and dorzagliatin, as either combination therapy or monotherapy. As per sources familiar with the matter, the pharmacodynamic results depicted a vivid synergistic effect in efficacy, under combination therapy. On the other hand, the PK results exhibited no impact whatsoever of empagliflozin (25 mg QD) and dorzagliatin (75 mg BID) and on their respective PK properties under co-administration.
Post OGTT, the combination treatment seemed to have accomplished enhanced glucose lowering effect (AUEC: 279 h*mg/dL) over dorzagliatin (AUEC: 364 h*mg/dL, P<0.05) monotherapy or empagliflozin (AUEC: 452 h*mg/dL, P<0.01). Increased C-peptide secretion had also been apparently observed for the combination treatment over empagliflozin monotherapy. Evidently, these results support the development of a combination therapy – dorzagliatin with empagliflozin, that will deliver improved outcomes for Type 2 diabetes patients.
Dr. Li Chen, Chief Executive Officer, Hua Medicine, has been quoted to state that HMM0112’s positive results are an indication of the fact that the add-on of dorzagliatin to SGLT-2 inhibitors has enhanced the blood sugar control for these patients, increasing the applicable patient population, apart from suggesting a synergistic impact of recovering pancreatic islet function. This successful outcome will advance Hua’s mission of offering dorzagliatin either as a monotherapy or in combination with the oral anti-diabetic drugs approved, Dr. Chen further added.
Dr. Chen also went on to say that presently, Hua has demonstrated similar positive results of dorzagliatin when combined with metformin (the global first-line oral anti-diabetic drug) and sitagliptin (a DPP-4 inhibitor and also a major oral anti-diabetic drug in the world). Through this manner, the company aims to deliver a new treatment for Type 2 diabetes patients so as to prevent or delay the occurrence of the diabetes, he added.
Source Credits: https://www.huamedicine.com/show_news.asp?s_id=65