Phase 3 trial for Korea-made DPP-4 + SGLT-2 approved

Dong-A ST Suganon’s combination therapy with metformin and dapagliflozin

LG Chem Zemiglo’s combination drug with metformin and dapagliflozin

Apparently, Phase III clinical protocols of two new Korea-made anti-diabetic treatments based on DPP-4 inhibitor, Suganon (evoglitin by Dong-A ST) and Zemiglo (gemigliptin by LG Chem), have been approved to test their combination efficacy with SGLT-2 inhibitor drug.

 

Among nine new dipeptidyl peptidase 4 (DPP-4) inhibitor drugs competing in Korean anti-diabetic treatment market, the two investigational drugs are rare cases of Korea-developed drugs.

 

But also two of them have not yet confirmed combined efficacy with sodium-glucose cotransporter-2 (SGLT-2) inhibitor drug.

 

Currently, MSD’s Januvia, Bristol-Myers Squibb’s Onglyza, and Boehringer Ingelheim’s Trajenta are indicated in Korea as combination therapy with SGLT-2 inhibitor.

 

And recently, a few DPP-4 inhibitor plus SGLT-2 inhibitor combination drugs have been approved, but none of them are developed by a Korean company.

 

On Feb.

 

7, Ministry of Food and Drug Safety (MFDS) has approved Phase III protocols on Suganon plus metformin plus dapagliflozin combination therapy and Zemglo plus metformin plus dapagliflozin combination drug.

 

The health authority green lit Dong-A ST Suganon’s multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III trial that aims to test efficacy and safety of metformin plus evoglitin (brand name: Suganon) combination therapy added with dapagliflozin, treating type 2 diabetic patients with insufficient control of blood sugar level.

 

LG Chem’s Phase III protocol on gemigliptin (brand name: Zemiglo) plus SGLT-2 inhibitor combination drug has been cleared to test efficacy and safety of metformin plus gemigliptin plus dapagliflozin combination therapy treating type 2 diabetic patients, who cannot sufficiently control blood sugar level after treated by metformin monotherapy.

 

The Phase III trial would be multicenter, randomized, double-blind, double-placebo, active-control, parallel-group study comparing the investigational combination with dapagliflozin plus metformin combination therapy.

 

Dapagliflozin apparent in both combination therapies is AstraZeneca’s SGLT-2 inhibitor anti-diabetic treatment, Forxiga’s active pharmaceutical ingredient.

 

So far, Suganon has been indicated as monotherapy and combination therapy with metformin.

 

And Zemiglo has been indicated as combination therapy with metformin, combination therapy with metformin plus sulfonylurea, and combination therapy with insulin.

 

The most frequently used substance for anti-diabetic drug, DPP-4 inhibitor, controls blood sugar level by blocking enzyme dipeptidyl peptidase-4 to activate insulin-secretion stimulating hormone incretin.

 

SGLT-2 inhibitor inhibits sodium-glucose transport protein 2 to prevent reabsorption of glucose in the kidney to lower blood sugar level.

 

The medication is the newest drug in the anti-diabetic drug market rapidly increasing the volume in the market.

 

Experts evaluate the combined use of two drugs would be more effective as both DPP-4 inhibitor and SGLT-2 inhibitor medications have confirmed outstanding efficacy of controlling blood sugar level and safety.

 

But only limited number of drugs has been indicated as DPP-4 inhibitor plus SGLT-2 inhibitor combination therapy.

 

Moreover, those drugs are all imported.

 

The industry expects the Korea-made Suganon and Zemiglo to enhance their market competitiveness, when they win the SGLT-2 combination therapy indication.

 

According to UBIST last year, Suganon has generated 7 billion won for outpatient prescription, and Sugamet, an evogliptin plus metformin combination drug, generated 8.6 billion.

 

Moreover, Zemiglo has made 34 billion won, and its combination drug with metformin, Zemimet raised 63.5 billion won.

 

The overall DPP-4 inhibitor market volume in Korea is approximately 500 billion won.