Status:
UNKNOWN
Vitamin D, K2 Plus Empagliflozin Combination in Type Two Diabetes Mellitus
Lead Sponsor:
Scotmann Pharmaceuticals
Collaborating Sponsors:
University of Health Sciences Lahore
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
40-60 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Empagliflozin: Generally, Sodium-glucose co-transporter-2 inhibitors (SGLT2i), have important benefits for older people, such as a low risk of hypoglycemia, reduction of cardiovascular and renal risk...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT05417880
Start Date
August 1 2022
End Date
June 1 2023
Last Update
June 14 2022
Active Locations (1)
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1
University of Health Sciences
Lahore, Punjab Province, Pakistan, 48400