Vitamin D, K2 Plus Empagliflozin Combination in Type Two Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
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
详细描述
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, and an insulin-independent mechanism, allowing its use in disease of any duration. Advantages include lack of hypoglycemia as a side effect, and mild reduction in blood pressure and body weight.
The SGLT2i class is well-tolerated, though some caution is also suggested, including adjustment of concomitant therapies, such as insulin and antihypertensives, especially loop diuretics.
The 2022 latest guidelines by the American Diabetes Association recommend that if insulin is used in adults with type 2 diabetes, it is recommended that, for better efficacy and durability of treatment effect, combination therapy be employed using a glucagonlike peptide 1 receptor agonist and consideration may be given to combined therapy employing a sodium-glucose cotransporter 2 inhibitor and a glucagon-like peptide 1 receptor agonist, both with demonstrated cardiovascular benefit, "for additive reduction in the risk of adverse cardiovascular and kidney events" in patients "with type 2 diabetes and established atherosclerotic cardiovascular disease or multiple risk factors for atherosclerotic cardiovascular disease". Moreover, among patients with type 2 diabetes who have established atherosclerotic cardiovascular disease (ASCVD), sodiumglucose cotransporter-2 (SGLT2) inhibitors or glucacon-like peptide 1 (GLP-1) receptor agonists with proven cardiovascular benefit are recommended as part of glycemic management. The same guidelines recommend that among patients with ASCVD in whom heart failure coexists or is of special concern, SGLT2 inhibitors are recommended and patients who are unable to maintain glycemic targets on basal insulin in combination with oral medications can have treatment intensified with GLP-1 receptor agonists, SGLT2 inhibitors, or prandial insulin.
Conclusively, it is recommended that a sodium-glucose cotransporter-2 (SGLT2) inhibitor or glucagonlike peptide-1 receptor agonist (GLP-1 RA) with demonstrated cardiovascular disease benefit be administered to patients with type 2 diabetes who have established atherosclerotic cardiovascular disease (ASCVD), indicators of high ASCVD risk, established kidney disease, or heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 1 (Control group)
Continue with current oral anti-hyperglycemic regime
干预措施: Oral Hypoglycemic Agents,Oral (Drug)
Group 2 (Voreta group)
Empagliflozin 10 mg OD
干预措施: Voreta (Drug)
Group 3 ( Voreta + SunnyD PRO group )
Empagliflozin 10 mg OD + Vitamin D3 (2000 IU) + Vitamin K2 (100 mcg)
干预措施: Voreta plus SunnyD PRO (Drug)
结局指标
主要结局
HbA1c
时间窗: 3 months
Mean change in HbA1c levels in % from baseline to end of study at 3 months
Hypotension
时间窗: 3 months
Number of times ( frequency) the patient experienced low blood pressure during the defined study time frame
Fungal infections
时间窗: 3 months
Incidence of clinically diagnosed or patient's self-reported Fungal Infections during the time frame of study
Mean change on body weight in kilogram (kg)
时间窗: 3 months
Mean change in body weight in kilograms during the defined study time frame of 3 months from baseline
Total Cholesterol
时间窗: 3 months
Mean Change in Total Cholesterol at baseline and at the end of the study
Urinary Tract Infection
时间窗: 3 months
Incidence of clinically diagnosed or patient's self-reported Urinary Tract Infections
Low Density Lipoprotein (LDL-C)
时间窗: 3 months
Mean Change in Low Density Lipoprotein (LDL) at baseline and at the end of the study
Blood Pressure change
时间窗: 3 months
Mean Change in Systolic and Diastolic blood pressures at baseline and at the end of the study
Fasting Blood Sugar (FBS)
时间窗: 3 months
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
Random Blood Sugar (RBS)
时间窗: 3 months
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)
Dehydration
时间窗: 3 months
Number of times (frequency) the patient felt dehydrated during the defined time frame
Diabetic Ketoacidosis
时间窗: 3 months
Incidence of clinically diagnosed Diabetic Ketoacidosis during the defined time frame of study
High Density Lipoprotein (HDL)
时间窗: 3 months
Mean Change in High Density Lipoprotein (HDL) at baseline and at the end of the study
Triglycerides
时间窗: 3 months
Mean Change in Triglycerides at baseline and at the end of the study
次要结局
- Quality of sleep(3 months)
- Satisfaction with treatment and life(3 months)
- Backache(3 months)
- Pain Visual Analogue Scale (VAS)(3 months)
- Weakness/fatigue(3 months)
- Mood swings(3 months)
- Muscular aches and pain(3 months)
