Phase 4
Completed N=52
An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
Source: ClinicalTrials.gov NCT02433678 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use — 0.762; 0.733; 0.802; 0.835 arbitrary unit
◆ Published Evidence
Highly cited
189citations · ~32 / year
Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis.
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.
Linked Publications
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Dapagliflozin Suppresses Hepcidin And Increases Erythropoiesis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use |
0.762; 0.733; 0.802; 0.835; 0.776; 0.815 | — |
| SECONDARY Changes in Expression of Inflammatory Mediators |
0.762; 0.733; 0.776; 0.815 | — |
| SECONDARY Changes in Expression of Inflammatory Mediators |
0.762; 0.733; 0.776; 0.815 | — |
| SECONDARY Changes in Expression of Inflammatory Mediators |
0.762; 0.733; 0.776; 0.815 | — |
| SECONDARY Changes in Expression of Inflammatory Mediators |
0.762; 0.733; 0.776; 0.815 | — |
| SECONDARY Changes in Expression of Inflammatory Mediators |
0.762; 0.733; 0.776; 0.815 | — |
| SECONDARY Changes in Expression of Inflammatory Mediators |
0.762; 0.733; 0.776; 0.815 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT02433678) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.