Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.

NCT02919059 | Unknown Phase 4

• 1 other identifier: ESR-14-10158
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2; DM

Outcome Measures

Primary Outcomes (1)

• Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period regarding central systolic blood pressure

  To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central systolic blood pressure estimated by applanation tonometry

  24 weeks

Secondary Outcomes (6)

• Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central systolic/diastolic blood pressure

  24 weeks

• Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central pulse pressure

  24 weeks

• Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure

  24 weeks

• Type and number of Adverse events in patienteSafety and tolerability of dapagliflozin relative to glimepiride.

  28 weeks

• Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation pressure

  24 weeks

Study Arms (2)

Dapagliflozin 10 mg

EXPERIMENTAL

Dapagliflozin 10 mg once daily during 24 weeks

Drug: Dapagliflozin 10 mg

Glimepiride 4 mg

ACTIVE COMPARATOR

Glimepiride 4 mg once daily during 24 weeks

Drug: Glimepiride 4 mg

Interventions

Dapagliflozin 10 mg DRUG

Dagliflozin will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.

Also known as: Dapagliflozin

Dapagliflozin 10 mg

Glimepiride 4 mg DRUG

Glimepiride will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.

Also known as: Glimepiride

Glimepiride 4 mg

Eligibility Criteria

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

You may qualify if:

• T2DM subjects with uncontrolled glycaemia, based on HbA1c levels (10% ≥ HbA1c ≥ 7%) at Visit 1.
• Patients may be treated for \>3 months with a stable doses of metformin at optimal doses tolerated.
• Participants will be able to give and sign informed consent form.
• Age \> 18 years of either gender.

You may not qualify if:

• Patients with two or more different oral antihyperglycemic agents.
• HbA 1c levels \> 10%.
• Systolic BP \>160 mm Hg and/or diastolic BP \> 100 mm Hg before randomization.
• History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation or diabetes secondary to any condition.
• History of one or more severe hypoglycaemic episode within 6 months before screening.
• Myocardial infarction, unstable angina pectoris, congestive heart failure, life threatening arrhythmia, history of cerebrovascular accident within 3 months.
• Clinically relevant renal disease; defines if serum creatinine equal or lager than 1.5 mg/dl or eGFR \< 60 ml/min/1.73m2, at screening.
• Liver function abnormal: glutamic-oxalacetic transaminase lager than 2 times of upper limit normal or glutamic-pyruvic transaminase lager than 2 times of upper limit normal
• Existence of any serious systemic disease
• Allergic history to the compounds of study medication
• Can not comply the study protocol or misunderstand the informed consent form
• Women of childbearing potential will be required to use a double-barrier method of birth control throughout study participation. Women who are surgically sterile or documented post-menopausal for at least 2 years are not considered to be of childbearing potential.
• Pregnant or breast-feeding or planning to become pregnant during the study.
• History of alcohol abuse (\>350 g/week) within 3 years before screening.
• Concurrent therapy with medications that could be affect glycaemia (e.g. corticosteroids) or disallowed therapy (e.g. digoxin).

Sponsors & Collaborators

• IInstituto Gallego de Medicina Vascular: lead

Study Sites (1)

Hospital Nuestra Señora de la Esperanza

Santiago de Compostela, Galicia, 15705, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; glimepiride

Condition Hierarchy (Ancestors)

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

Study Officials

• Alvaro Hermida, MD, PhD

  Hospital Nuestra Señora de la Esperanza

  STUDY DIRECTOR

Central Study Contacts

Alvaro Hermida, MD, PhD

CONTACT

0034 981 552 200; alvaro.hermida.ameijeiras@sergas.es

Study Design

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

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 29, 2016
• Study Start: December 13, 2016
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: March 29, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)