Effects of Dapagliflozin on Central Hemodynamics and Urine Albumin Excretion in Patients With Type 2 Diabetes.

NCT02887677 | Terminated Phase 4

• 1 other identifier: ESR-15-10964
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed to test the hypothesis that the treatment-induced reductions in the ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the group of placebo. It is a 12 week, double-blind, randomized, placebo-controlled clinical trial of dapagliflozin versus placebo in 160 adult patients with type 2 diabetes mellitus (DM). It will be conducted in three centers. Potentially eligible patients will be asked to provide written informed consent (Screening Visit). Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit the sites one week (Visit 1 - V1) after the screening visit. On Visit 2 (V2) all eligible patients will be randomized to one of the two treatment arms and will continue with the next visits as appropriate (Visit 3, Telephone Visit 1, Visit 4-end of study). Aortic blood pressure (BP) and arterial stiffness parameters will be measured as indicated by the protocol in V1 and V3 with the Mobil-O-Graph monitor. Blood samples will be collected as indicated by the protocol in Screening Visit for the measurement of glycated hemoglobin (HbA1c), creatinine and liver function parameters. In addition, blood samples will be collected in V1 and V3 for routine hematological and biochemical tests including creatinine, fasting glucose, HbA1c, lipid profile and liver function parameters. Urine samples will be collected as indicated by the protocol in V1 and V3 for the measurement of albumin to creatinine ratio.

Conditions

Diabetes Mellitus

Keywords

Dapagliflozin; Arterial Stiffness; Aortic Pressure

Outcome Measures

Primary Outcomes (1)

• Ambulatory systolic aortic pressure

  12 weeks

Secondary Outcomes (8)

• Ambulatory aortic (central) diastolic blood pressure (DBP)

  12 weeks

• Ambulatory brachial systolic blood pressure (SBP) and DBP

  12 weeks

• Ambulatory augmentation index (AIx)

  12 weeks

• Ambulatory pulse wave velocity (PWV)

  12 weeks

• Office brachial SBP and DBP

  12 weeks

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

Dapagliflozin for oral administration. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group.

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo for oral administration. Patients will be randomized in a 1:1 ratio to the dapagliflozin or placebo group.

Drug: Placebo

Interventions

Dapagliflozin DRUG

Administration of dapagliflozin (film-coated tablet of 10mg, per os, q24h, 12 weeks)

Also known as: Forxiga

Dapagliflozin

Placebo DRUG

Administration of placebo (film-coated tablet of same color and texture with dapagliflozin, 10mg, per os, q24h, 12 weeks).

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 and ≤75 years old
• Type 2 diabetes mellitus
• Glycated hemoglobin ≥7% and ≤ 9%
• Patients on monotherapy or combination of two of the following type of antidiabetic agents :metformin, sulphonylurea,DPP-4 inhibitor,or insulin for the past 3 months.
• Patient to provide informed consent

You may not qualify if:

• Hypovolemic patients.
• Patients on loop diuretics.
• Patients with low BP (office SBP \<110 mmHg) or orthostatic hypotension (BP drop \>20 mmHg and SBP \<110 mmHg in standing position at 1 min).
• Patients on GLP-1 receptor agonist or pioglitazone.
• Secondary hypertension.
• Stage 2 hypertension or higher (office SBP ≥160 mmHg or DBP ≥100 mmHg).
• Chronic kidney disease stage 3 or higher (GFR\<60 mL/min/1.73 m2).
• Myocardial infarction or unstable angina episode within the past 3 months, or congestive heart failure class III-IV according to New York Heart Association criteria.
• Pregnancy or childbearing potential \[defined as women which have entered menses and are not post-menopausal (menopause is defined as the absence of menses for at least 12 months without any other medical cause in women of typical age) or women that have been subjected to permanent sterilization (ie. tubal ligation, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)\].
• History of liver disease or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN or total bilirubin \>2.0 mg/dL.
• History of malignancy of any organ system (resected basal cell carcinoma considered cured is exempted) within the past 5 years prior to Visit 1 (V1).
• History of drug or alcohol abuse within the last one year.
• Any contraindication or history of hypersensitivity to the study drug or to drugs with similar chemical structures.
• Any other surgical or medical condition that, in the opinion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
• Intake of an investigational drug in another trial within 30 days prior to Visit 1 (V1).

Sponsors & Collaborators

• Hellenic Society for Medical Education: lead

Study Sites (3)

Ahepa Hospital

Thessaloniki, 54621, Greece

Location

Hippokrateio Hospital

Thessaloniki, 54642, Greece

Location

Papageorgiou Hospital

Thessaloniki, 56429, Greece

Location

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MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Pantelis Sarafidis

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 2, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: October 1, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)