Trials / Completed
CompletedNCT02433678
An Investigation Into The Anti-hypertensive And Potential Anti-inflammatory Actions Of Dapagliflozin
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- University at Buffalo · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Two groups of 26 patients each (total 52 patients) with type 2 diabetes on oral agents will be included in the study. One group will be randomized to dapagliflozin (a dose of 5 mg daily will be titrated to 10 mg daily during the first week) while the other will be placebo. The patients will be treated for 12 weeks. Only half the patients (equal numbers in both groups) will be tested for the secondary endpoints related to postprandial and single dose induced changes. The primary endpoint of the study is to detect a significant difference in the percent change in fasting Nuclear factor-k B (NFκB) activation (DNA binding activity) in mononuclear cells (MNC) before and after dapagliflozin use (0 week vs. 12 weeks) as compared to placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dapagliflozin | SGLT-2 inhibitor for the treatment of type 2 diabetes |
| DRUG | Placebo |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2018-03-01
- Completion
- 2018-11-01
- First posted
- 2015-05-05
- Last updated
- 2019-10-30
- Results posted
- 2019-10-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02433678. Inclusion in this directory is not an endorsement.