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Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372955
Recruitment Status : Unknown
Verified February 2015 by Thomas Giles, Gulf Regional Research & Educational Services, LLC.
Recruitment status was:  Recruiting
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Giles, Gulf Regional Research & Educational Services, LLC

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: dapagliflozin Drug: glimpiride Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mechanistic Study of the Systolic Blood Pressure Lowering Effect of Dapagliflozin in Type 2 Diabetes
Study Start Date : February 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dapagliflozin 10 mg daily
dapagliflozin, 10 mg daily for 16 weeks
Drug: dapagliflozin
subjects will be randomly assigned to receive dapagliflozin 10 mg daily
Other Name: Farxiga

Active Comparator: glimpiride
glimpiride 4 mg daily for 16 weeks
Drug: glimpiride
subjects will be randomly assigned to receive glimpiride 4 mg daily
Other Name: Amaryl




Primary Outcome Measures :
  1. systolic blood pressure by ambulatory blood pressure monitoring (ABPM) [ Time Frame: 16 weeks ]
  2. arterial stiffness [ Time Frame: 16 weeks ]
    arterial stiffness will be assessed by measuring aortic pulse wave velocity (aPWV) and augmentation index


Secondary Outcome Measures :
  1. urinary sodium excretion [ Time Frame: 16 weeks ]
  2. composite intravascular volume status [ Time Frame: 16 weeks ]
    jugular venous pressure, body weight, orthostatic change in BP and pulse rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372955


Contacts
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Contact: Thomas D Giles, MD 504.834.8668 tgiles4@cox.net
Contact: Louise E Roffidal, BSN, MPH 504.220.6275 lroffidal.grres@gmail.com

Locations
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United States, Louisiana
Gulf Regional Research & Educational Services, LLC Recruiting
Metairie, Louisiana, United States, 70002
Contact: Thomas D Giles, MD    504-834-8668    tgiles4@cox.net   
Contact: Louise E Roffidal, BSN, MPH    504.220.6275    lroffidal.grres@gmail.com   
Sponsors and Collaborators
Gulf Regional Research & Educational Services, LLC
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Responsible Party: Thomas Giles, Medical Director, Gulf Regional Research & Educational Services, LLC
ClinicalTrials.gov Identifier: NCT02372955    
Other Study ID Numbers: ESR-14-10022/D1690L00020
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs