Vitamin D, K2 Plus Empagliflozin Combination in Type Two Diabetes Mellitus

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the VETA trial is to verify the potential beneficial effects of the combination of micronutrients namely Vitamin D3 and K2 in combination with oral antihyperglycemic Empagliflozin in Diabetes Mellitus

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scotmann Pharmaceuticals
• Collaborator: University of Health Sciences Lahore
• Treatments: Hypoglycemic Agents

Criteria

Inclusion Criteria:

• Patients aged 40-60 years

• Type 2 DM for at least 10 years

• Currently on at least 1 regular monotherapy of oral Anti-hyperglycemic agents

• Vitamin D levels < 30 mg/mL

Exclusion Criteria:

Other types of Diabetes

• Pregnant or lactating mothers or women of child bearing potential not practicing an acceptable method of birth control

Diabetic ketoacidosis (DKA) and/or recent history of DKA in last 3 months

• Severe renal (CKD Stage 5, ESRD, eGFR < 45 mL/min/1.73 m 2 or dialysis) or hepatic impairment (Liver cirrhosis, hepatitis)

• Presence of any of the following diseases o Hypothyroidism/hyperthyroidism o Blood disorders causing unstable red blood cells or hemolysis, blood dyscrasias o Benign Prostate Hyperplasia o Recent Acute Coronary Syndrome (ACS), stroke or transient Ischemic attack (TIA) in last 3 months.

• Patients taking any of the following medications o Anti-epileptics o Diuretics o Insulin or Insulin Secretagogues o Anti-Obesity or weight loss drugs (eg Orlistat)

• Presence of any granulomatous disease like Tuberculosis or sarcoidosis

• History of allergy or hypersensitivity reaction to Empagliflozin, Cholecalciferol or Menaquinone MK-7

• Risk of hypotension including low systolic Blood pressure

• Patients with recurrent and/or recent (past 3 months) history of Urosepsis, Pyelonephritis, Urinary Tract Infections and genital mycotic infections and/or positive Urine Culture

• High Low Density Lipoprotein (LDL-C) > 160 mg/dL