Recruiting

Dapagliflozin

Sponsor:

Gulf Regional Research & Educational Services, LLC

Code:

NCT02372955

Conditions

Diabetes Mellitus Type 2

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

dapagliflozin

glimpiride

Study Details

Brief summary:

Dapagliflozin has been shown to lower clinic systolic and diastolic blood pressure in patients with type 2 diabetes mellitus. The exact mechanism(s) by which dapagliflozin lowers clinic SBP is unknown. The primary objective of the study is to determine the effect of dapagliflozin , 10 mg daily, on parameters of arterial stiffness: aPWV, augmentation index (AI), 24-hour blood pressure patterns, SBP, and pulse pressure. Urinary sodium excretion, and Intravascular volume status will be recorded. The study will involve 21 subjects for a duration of 16 weeks.

Conditions

Diabetes Mellitus Type 2

Study ID

NCT02372955

Start date

Feb, 2015

Status verified date

Feb, 2015

Completion date

Dec, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Metformin treatment

Exclusion Criteria:

  • • Type 1 diabetes mellitus

  • Hgb A1c > 9
  • Advanced diabetic complications, e.g. diabetic renal disease (eGFR < 60 cc/min), heavy proteinuria, diabetic retinopathy, autonomic neuropathy
  • Pregnancy or unwilling to practice contraception.
  • Uncontrolled hypertension (SBP > 150 mm Hg; DBP > 100 mm Hg)
  • Chronic substance abusers
  • Carcinoma of the urinary bladder
  • Subjects deemed at risk for dehydration

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: dapagliflozin 10 mg daily

dapagliflozin, 10 mg daily for 16 weeks

active comparator: glimpiride

glimpiride 4 mg daily for 16 weeks

Interventions

dapagliflozin

subjects will be randomly assigned to receive dapagliflozin 10 mg daily

glimpiride

subjects will be randomly assigned to receive glimpiride 4 mg daily

Primary outcome measure

  • systolic blood pressure by ambulatory blood pressure monitoring (ABPM) [ Time Frame: 16 weeks ]
  • arterial stiffness [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Thomas D Giles, MD

504.834.8668tgiles4@cox.net

Louise E Roffidal, BSN, MPH

504.220.6275lroffidal.grres@gmail.com

Locations

Gulf Regional Research & Educational Services, LLC

Recruiting

Metairie, Louisiana, United States, 70002

Contacts

Thomas D Giles, MD

504-834-8668tgiles4@cox.net

Louise E Roffidal, BSN, MPH

504.220.6275lroffidal.grres@gmail.com

More Information

Sponsor

Gulf Regional Research & Educational Services, LLC

Last update posted

Feb 26, 2015

Last verified

Feb, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gulf Regional Research & Educational Services, LLC on 2015-02-26.