A pharmaceutical firm has developed a glucokinase activator that may lead to diabetic remission, according to reports on September 26. Is it really a DREAM come true?

Diabetes remission with Dorzagliatin - A DREAM come true?

In a study conducted by Hua medicine, a first-in-class novel drug Dorzagliatin may be a "Dream" come true in the field of diabetes according to phase III of the SEED study. In the "DREAM" research of the study, individuals with drug-naive type 2 diabetes are being studied to see whether dorzagliatin, a first-of-its-kind glucokinase activator, is safe and effective in the same way it was in the Phase III SEED study, which was performed in healthy volunteers.

Its primary goal is to see if patients who took part in the SEED trial and attained the investigators' definition of glycaemic control can maintain it for at least 52 weeks without the assistance of any glucose-lowering medication. In fact, a large number of them did so. The study's findings revealed that 65.2% of the 69 patients were in remission after 52 weeks.

DREAM study findings

Researchers involved in the SEED study started the DREAM project, an observational, non-pharmacological, and non-interventional clinical trial (also called HMM0301). Dorzagliatin as monotherapy in drug-naive type 2 diabetes patients is being studied in the SEED research for its long-term effectiveness and safety, which is registered as a phase III clinical trial.

To determine whether patients with type 2 diabetes who completed our SEED trial and achieved glycaemic control (i.e., type 2 diabetes remission) are able to keep their glucose levels near normal without the need for hypoglycaemic medications for at least a 52-week follow-up period after finishing the SEED study.

A total of 69 individuals took part in the DREAM research, which was performed at five clinical facilities in China. During the study period, the patients had a 52-week blood glucose remission rate of 65,2% (CI at 95 per cent, 53,4%, 77,0%) after the researchers evaluated them thoroughly and established their specific HbA1c control objectives.

Researchers have discovered a novel family of glucokinase activators (GKAs) called dorzagliatin, and have shown that it may significantly enhance early-phase insulin production, beta-cell function, and insulin resistance, leading to remission of type 2 diabetes in certain patients.

Dorzagliatin monotherapy had a favourable safety profile and showed sustained long-term effectiveness in the earlier SEED trial. Following dorzagliatin therapy, the DREAM research found that individuals with normal blood sugar levels could keep them and their beta-cell activity even after discontinuing the medication.

What is Dorzagliatin?

Patients with type 2 diabetes treated with the experimental glucokinase activator dorzagliatin, the first of its kind, may be able to slow the progression of their disease and prevent it from becoming irreversible. Difficult in the glucose sensor function, dorzagliatin may help patients with type 2 diabetes regain normal insulin and GLP-1 secretion and provide as a starting point for treatment that targets the disease's underlying causes.

Studies on the synergy of drug mechanisms including sitagliptin (DPP-4 inhibitor) and empagliflozin and two phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin were completed in China (SGLT-2 inhibitor).

The concept of diabetic remission has been discussed before. Diabetes remission with weight reduction is feasible for younger patients who lose more weight and have had the illness for a shorter length of time, according to Dr. Ebaa Al Ozairi, chief medical officer of the Dasman Diabetes Institute in Kuwait in 2020.

According to Dr. Ebaa Al Ozairi:

No longer can we say to our patients that diabetes is a chronic illness. Let them know that diabetes remission isn't just a myth; it's a genuine possibility. Type 2 diabetes therapy must be rethought in order to achieve remission if caught early.

In 2018, Novo Nordisk, the leading Danish diabetes company, stated that it was increasing its emphasis on stem cell treatment to replace the beta cells lacking in Type 1 diabetes patients in order to liberate patients from insulin dependency. Cell therapy efforts were given an update in February when the firm said that it planned to submit an investigational new drug (IND) application by the end of 2022, but that the first indication will be Parkinson's disease rather than diabetes.

The FDA authorised an investigational new drug (IND) for Vertex Pharmaceuticals' own cell treatment for Type 1 diabetes in January. With the recent publication of the ADA's Diabetes Remission Consensus Report, clinical researchers and medication companies have begun to reexamine how to prevent diabetes from becoming a lifelong condition. The DREAM study's encouraging findings have given us more hope for finding a cure for type 2 diabetes.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.