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Clinical Trial Details

Trial ID: L2733
Source ID: NCT05417880
Associated Drug: Oral Hypoglycemic Agents,Oral
Title: Vitamin D, K2 Plus Empagliflozin Combination in Type Two Diabetes Mellitus
Acronym: VETA
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus
Interventions: DRUG: Oral Hypoglycemic Agents,Oral|DRUG: Voreta|DRUG: Voreta plus SunnyD PRO
Outcome Measures: Primary: 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: Pain Visual Analogue Scale (VAS), Mean Change in Pain Visual Analogue Scale (VAS) at baseline and at the end of the study. The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). Higher the score, more the pain., 3 months|Weakness/fatigue, Patient's reported weakness, fatigue, tiredness or any subjective improvement, 3 months|Muscular aches and pain, Presence/absence of muscular aches and pain, 3 months|Backache, Presence/absence of backache and its severity and frequency, 3 months|Quality of sleep, Patient-reported quality of sleep during the study period, 3 months|Mood swings, Patient-reported incidence/frequency of mood swings including episodes of depression and anxiety, 3 months|Satisfaction with treatment and life, Patient-reported overall satisfaction with treatment and life, 3 months
Sponsor/Collaborators: Sponsor: Scotmann Pharmaceuticals | Collaborators: University of Health Sciences Lahore
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 340
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-08
Completion Date: 2023-06
Results First Posted:
Last Update Posted: 2022-06-14
Locations: University of Health Sciences, Lahore, Punjab, 48400, Pakistan
URL: https://clinicaltrials.gov/show/NCT05417880