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

NCT05417880 | Unknown Phase 3 DMC

• 1 other identifier: VETAtrial
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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 in Diabetes Mellitus

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Empagliflozin; Vitamin D3; Vitamin K2

Outcome Measures

Primary Outcomes (14)

• HbA1c

  Mean change in HbA1c levels in % from baseline to end of study at 3 months

  3 months

• Fasting Blood Sugar (FBS)

  Mean change in Fasting blood sugar ( serum levels of Glucose in mg/dL after 6-8 hours of fasting) from baseline to end of study at 3 months

  3 months

• Random Blood Sugar (RBS)

  Mean change in Random blood sugar from baseline to end of study at 3 months. ( A random glucose test is one method for measuring the amount of glucose or sugar circulating in a person's blood. Doctors perform this test and use the result to determine whether a person is likely to have diabetes)

  3 months

• Hypotension

  Number of times ( frequency) the patient experienced low blood pressure during the defined study time frame

  3 months

• Dehydration

  Number of times (frequency) the patient felt dehydrated during the defined time frame

  3 months

• Urinary Tract Infection

  Incidence of clinically diagnosed or patient's self-reported Urinary Tract Infections

  3 months

• Diabetic Ketoacidosis

  Incidence of clinically diagnosed Diabetic Ketoacidosis during the defined time frame of study

  3 months

• Fungal infections

  Incidence of clinically diagnosed or patient's self-reported Fungal Infections during the time frame of study

  3 months

• Mean change on body weight in kilogram (kg)

  Mean change in body weight in kilograms during the defined study time frame of 3 months from baseline

  3 months

• Blood Pressure change

  Mean Change in Systolic and Diastolic blood pressures at baseline and at the end of the study

  3 months

• Total Cholesterol

  Mean Change in Total Cholesterol at baseline and at the end of the study

  3 months

• High Density Lipoprotein (HDL)

  Mean Change in High Density Lipoprotein (HDL) at baseline and at the end of the study

  3 months

• Low Density Lipoprotein (LDL-C)

  Mean Change in Low Density Lipoprotein (LDL) at baseline and at the end of the study

  3 months

• Triglycerides

  Mean Change in Triglycerides at baseline and at the end of the study

  3 months

Secondary Outcomes (7)

• Pain Visual Analogue Scale (VAS)

  3 months

• Weakness/fatigue

  3 months

• Muscular aches and pain

  3 months

• Backache

  3 months

• Quality of sleep

  3 months

Study Arms (3)

Group 1 (Control group)

ACTIVE COMPARATOR

Continue with current oral anti-hyperglycemic regime

Drug: Oral Hypoglycemic Agents,Oral

Group 2 (Voreta group)

ACTIVE COMPARATOR

Empagliflozin 10 mg OD

Drug: Voreta

Group 3 ( Voreta + SunnyD PRO group )

EXPERIMENTAL

Empagliflozin 10 mg OD + Vitamin D3 (2000 IU) + Vitamin K2 (100 mcg)

Drug: Voreta plus SunnyD PRO

Interventions

Oral Hypoglycemic Agents,Oral DRUG

Control group with routine current oral hypoglycemic agents for 3-6 months

Also known as: Control group

Group 1 (Control group)

Voreta DRUG

Empagliflozin 10 mg oral tablets Once Daily for 3-6 months

Also known as: Voreta group

Group 2 (Voreta group)

Voreta plus SunnyD PRO DRUG

Empagliflozin 10 mg oral tablets + Vitamin D3 ( 2000 IU ) + Vitamin K2 ( 100 mcg) Once Daily for 3-6 months

Also known as: Voreta and SunnyD PRO group

Group 3 ( Voreta + SunnyD PRO group )

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scotmann Pharmaceuticals: lead
• University of Health Sciences Lahore: collaborator

Study Sites (1)

University of Health Sciences

Lahore, Punjab Province, 48400, Pakistan

Location

Related Publications (1)

• Wanner C, Inzucchi SE, Lachin JM, Fitchett D, von Eynatten M, Mattheus M, Johansen OE, Woerle HJ, Broedl UC, Zinman B; EMPA-REG OUTCOME Investigators. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016 Jun 14.

  PMID: 27299675 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Javed Akram, MRCP,FRCP

  University of Health Sciences Lahore

  STUDY CHAIR

• Zaman Shaikh, MRCP,MSc

  Sir Syed Medical hospital, Khi College of Sciences & Qayyumabad,Khi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syeda Saba Aslam, MBBS, MPH

CONTACT

00923136674333; medicalaffairs@scotmann.com.pk

Suhail Khan, MSc

CONTACT

03332000853; suhailkhan@scotmann.com.pk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective Randomized controlled trial

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 14, 2022
• Study Start: August 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)