Phase 4
Completed N=11
Inhibition of Urinary Angiotensinogen and the Reduction of Blood Pressure by SGLT2 Inhibition in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT02796170 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcomePrimary: Change in Blood Pressure From Baseline to 6 Weeks Measured by ABPM — -10.72; 1.94; -3.34; 1.56 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To assess the effect of sodium-glucose cotransporter 2 (SGLT-2) inhibitors on blood pressure and urinary angiotensinogen. This is a cross over study design, where 40 subjects will receive Dapagliflozin for 6 weeks followed by placebo for 6 weeks, or placebo for 6 weeks followed by Dapagliflozin for 6 weeks. In addition there will be an arm of 10 subjects who will receive sulfonylurea in an open label as a comparative to the cross over subjects to assess if the effect of Dapagliflozin may also be in part due to improved glycemic control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood Pressure From Baseline to 6 Weeks Measured by ABPM |
-10.72; 1.94; -3.34; 1.56 | — |
| SECONDARY Change in Urinary AGT Levels From Baseline to 6 Weeks |
53.85; 39.69 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes with hypertension and on RAAS blocking drugs OR
- Type 2 diabetes without hypertension and not on RAAS blocking drugs
- Hemoglobin A1c between 7% and 9% (inclusive)
- Estimated glomerular filtration rate (eGFR) ≥60 ml/min
- Capacity to understand and sign informed consent
Exclusion Criteria
- Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3x upper limit of normal (ULN)
- Total bilirubin >2.0 mg/dL
- Positive serologic evidence of current infectious liver disease, including Hepatitis B viral antibody immunoglobulin M (IGM), Hepatitis B surface antigen, and Hepatitis C virus antibody
- Estimated glomerular filtration rate (eGFR) <60 ml/min
- Recent cardiovascular events with the last 2 months: acute coronary syndrome (ACS), hospitalization for unstable angina or acute myocardial infarction, acute stroke or transient ischemic attack (TIA), or post coronary artery revascularization
- Congestive Heart Failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure
- Pregnant or breastfeeding patients
- Patients who, in the judgement of the investigator, may be at risk for dehydration
- Blood pressure at enrollment: Systolic ≥165 mmHg and/or Diastolic ≥110 mmHg; At randomization: Systolic ≥160 mmHg and/or Diastolic ≥100 mmHg
- Use of SGLT-2 inhibitor class drugs is an exclusion for all patients. For patients in the sulfonylurea arm, use of sulfonylurea class drugs is an exclusion.
Data sourced from ClinicalTrials.gov (NCT02796170). 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.