An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, prospective, randomized, placebo -controlled, parallel design and double blind study to evaluate oxidative stress, inflammation and hypertension markers and mediators before and after treatment with dapagliflozin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University at Buffalo
• Collaborator: Kaleida Health
• Treatments: Anti-Inflammatory Agents; Antihypertensive Agents; Dapagliflozin

Criteria

Inclusion Criteria:

• Age 20-80 years inclusive.

• Type 2 diabetes

• BMI ≥30 kg/m2

• Subjects on statins, ACE inhibitors, ARBs, thiazolidinediones and -antioxidants will be allowed as long as they are on stable doses of these -compounds and the dosage in not changed during the course of study. -Patients will be evenly distributed between the 2 groups based on statins, -ARBs, TZDs and ACE inhibitors use.

• HbA1c ≤ 8.0%

Exclusion Criteria:

• Use of GLP-1 agonists or DPP-IV or SGLT-2 inhibitors therapy in the last 3 -months.

• Risk for pancreatitis, i.e., history of gallstones, alcohol abuse, and -hypertriglyceridemia.

• Coronary event or procedure (myocardial infarction, unstable angina, coronary -artery bypass, surgery or coronary angioplasty) in the previous 3 months.

• Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver -function defined as:

• aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or -alanine aminotransferase (ALT) >3x ULN

• Total bilirubin >2.0 mg/dL (34.2 µmol/L)

• Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody

• (liver function tests more than 3 times the upper limit of normal)

• Renal impairment (serum eGFR <60 ml/min)

• Any other life-threatening, non-cardiac disease

• Uncontrolled hypertension (BP > 160/100 mm of Hg)

• Congestive Heart Failure class III or IV.

• Use of an investigational agent or therapeutic regimen within 30 days of study

• Participation in any other concurrent clinical trial

• pregnant or breastfeeding patients

• Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics