跳至主要内容
临床试验/NCT05417880
NCT05417880Unknown3 期

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

Scotmann Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2022年8月最近更新:
适应症
干预措施

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

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)

Active Comparator

Continue with current oral anti-hyperglycemic regime

干预措施: Oral Hypoglycemic Agents,Oral (Drug)

Group 2 (Voreta group)

Active Comparator

Empagliflozin 10 mg OD

干预措施: Voreta (Drug)

Group 3 ( Voreta + SunnyD PRO group )

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验