New clinical trial to investigate impact of vitamin K2 and D3 in combination with diabetes medication

Photo © iStockphoto.com/nicolas_

Gnosis by Lesaffre (Marcq-en-Baroeul, France) has announced the publication of a new study protocol initiated by Scotmann Pharmaceuticals, Pakistan, who will execute a large scale, multi-centered study examining the impact of Empagliflozin, an oral anti-diabetic, in combination with vitamins K2 and D3 on various diabetic parameters, including quality-of-life. Scotmann will use vitamin K2 MK7 supplied by Gnosis by Lesaffre. Dubbed the VETA Trial (Vitamin D, K2 plus Empagliflozin combination in Type Two Diabetes Mellitus), the six-month prospective, randomized, controlled, open-label, multicenter trial will be conducted in collaboration with the University of Health Sciences Lahore (Pakistan) and the Pakistan Society of Internal Medicine.

The VETA Trial will enroll 340 participants, aged 40-60 years and having Type 2 Diabetes Mellitus (T2DM) for at least 10 years. Subjects will be allocated as follows: 1) the control group (continuing current oral anti-hyperglycemic other than SGLT2 inhibitors and no added D3 or K2 supplementation), 2) an interventional group receiving either 10 mg Empagliflozin (a medication used together with diet and exercise to treat Type 2 diabetes; as VORETA tablets), or 3) an interventional group receiving 10 mg Empagliflozin plus the combination of 2,000 IUs of vitamin D3 and 100 mcg of Vitamin K2 as MK7 (as SunnyD PRO soft gel). The doses of both Empagliflozin tablets and the combination D3 + K2 soft gel will be taken once daily.

“The idea is to follow the holistic approach guidelines for the management of T2DM,” says Syeda Saba Alsam, MBBS, head of Medical Affairs and Research with Scotmann Pharmaceuticals, Pakistan, in a press release. Alsam notes that baseline screening of serum 25(OH)D3 levels would be done on all patients. “Since Vitamin D deficiency is highly prevalent in this cohort and a typical Pakistani diet lacks Vitamin K2, we are exploring the potential beneficial effects of these two micronutrients in Diabetic patients,” she explains.

“While treatment is crucial for diabetes, the proper nutrient intake is also important for this group of patients. Deficiency of vitamin D is globally recognized; however, the research suggests that vitamin D3 should be combined with vitamin K2 for synergistic impact. Further, it has been shown that vitamin K2 supplementation can effectively improve clinical features of diabetes,” said Sophie Legrain, Gnosis by Lesaffre’s director of R&D, citing a study¹ that showed vitamin K2 intake, specifically, produced a 7% reduction in T2DM risk with each 10 mcg increment. “It is exciting to see our partner exploring the impact K2 and D3 could have for patients adding it to their therapy.”

Reference

1. Beulens JW, et al. “Dietary phylloquinone and menaquinones intakes and risk of type 2 diabetes.” Diabetes Care, vol 33 (2010): 1699–705.