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

Completed · Phase 4 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT02433678

Run by

University at Buffalo

People needed

52

Starts

2015-11-01

Expected to finish

2018-11-01

Last updated by the study team

2019-10-30

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• ECMC Ambulatory Center, 3rd Floor — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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