SGLT-2 Inhibition, Metabolomics and Cardiovascular Disease

Phase 1

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-005136-41-ES
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina Y Salud (FIMABIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Age 18-75.
- BMI 27-39.9 kg/m2.
- T2DM under treatment with metformin and inadequate metabolic control (defined as HbA1c=6.5% and =7%).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Pregnancy (all women of child-bearing age, unless treatment with contraceptive methods, will undergo a pregnancy test)
- Intolerance/allergy to dapagliflozin.
- Treatment with antidiabetic drug other than metformin.
- Impaired kidney function: Estimated glomerular filtration rate (eGFR) (calculated using the CKD-EPI formula) <60 ml/min/1.73m2.
- Patients with established cardiovascular disease.
- Previous or current history of cancer of any kind.
- Uncontrolled hypertension (systolic blood pressure=160 mmHg or diastolic blood pressure=110 mmHg, despite adequate antihypertensive treatment).
- History of liver tumour or acute or chronic liver disease with impaired liver function: total bilirubin levels> 2.0 mg / dl or GOT levels three times higher than normal upper limit.
- Known HIV infection or active HBV or HCV infection.
- Serious underlying diseases, which could affect the patient's ability to participate in the study.
- Reduced life expectancy (<12 months) due to the presence of advanced or terminal concomitant diseases.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the metabolomics changes associated with dapagliflozin or placebo after 12 weeks of treatment, both in plasma and urine;<br> Secondary Objective: - Changes in body mass index (BMI) after 12 weeks of treatment with dapagliflozin or placebo.<br> - Changes in insulin resistance (measured by HOMA-IR) after 12 weeks of treatment with dapagliflozin or placebo.<br> - Changes in HbA1c after 12 weeks of treatment with dapagliflozin or placebo.<br> - Changes in the SF-36 questionnaire (quality of life) after 12 weeks of treatment with dapagliflozin or placebo.<br> ;Primary end point(s): Metabolomics changes, both in plasma and urine.;Timepoint(s) of evaluation of this end point: Baseline and after 12 weeks of treatment with dapagliflozin or placebo.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - BMI changes<br> - Insulin resistance changes (measured as HOMA-IR)<br> - Metabolic control (measured as HbA1c)<br> - Quality of Life (measured as SF-36 questionnaire).<br> ;Timepoint(s) of evaluation of this end point: Baseline and after 12 weeks of treatment with dapagliflozin or placebo.