SGLT-2 Inhibition, Metabolomics and Cardiovascular/Kidney Disease

NCT03919656 | Completed Phase 4 DMC

• 1 other identifier: FIM-DAPA-2018-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.

Conditions

Type 2 Diabetes Mellitus

Keywords

Metabolomics; Dapagliflozin

Outcome Measures

Primary Outcomes (2)

• Metabolomics changes in blood

  Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines

  From baseline to week 12

• Metabolomics changes in urine

  Targeted and quantitative analysis by ultra-high-resolution liquid chromatography coupled to triple quadrupole mass spectrometry (UHPL-QqQ/MS). Analysis of specific families of metabolites selected from hypotheses generated by previous exploratory studies: changes in acylcarnitines and other intermediates of mitochondrial β-oxidation and the urea cycle, branched-chain amino acids and biogenic amines

  From baseline to week 12

Secondary Outcomes (5)

• BMI (body mass index) changes

  From baseline to to week 12

• Changes in insulin resistance

  From baseline to to week 12

• Changes in metabolic control

  From baseline to to week 12

• Changes in Quality of Life: 36-Item Short Form Health Survey (SF-36) questionnaire

  From baseline to to week 12

• Changes in albuminuria

  From baseline to to week 12

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg daily (orally)

Drug: Dapagliflozin 10 mg

Placebo

PLACEBO COMPARATOR

Matching placebo for dapagliflozin daily (orally). Does not contain active ingredient

Drug: Placebo Oral Tablet

Interventions

Dapagliflozin 10 mg DRUG

Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)

Also known as: Farxiga 10 mg

Dapagliflozin

Placebo Oral Tablet DRUG

Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient

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 18-75.
• BMI 27-39.9 kg/m2.
• T2DM on treatment with metformin and inadequate metabolic control (defined as HbA1c≥6.5 -7%).

You may not qualify if:

• Pregnancy (all women of child-bearing age, unless on treatment with contraceptive methods, will undergo a pregnancy test)
• Breastfeeding
• Intolerance/allergy to dapagliflozin.
• Treatment with antidiabetic drug other than metformin.
• Impaired kidney function: Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 (calculated using the CKD-EPI formula).
• 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/GPT levels three times higher than normal upper limit.
• Known HIV infection or active HBV or HCV infection.
• Other serious underlying diseases, which could affect the patient's ability to participate in the study.
• Reduced life expectancy (\<12 months) due to advanced or terminal concomitant diseases.
• In addition, female patients of child-bearing age will be advised to use contraceptive methods during the study period, given the contraindication of dapagliflozin and metformin during pregnancy as per normal clinical practice.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead

Study Sites (1)

Virgen de la Victoria University Hospital. Endocrinology Department

Málaga, Spain, 29010, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose Carlos Fernandez-Garcia, MD, PhD

  Virgen de la Victoria Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Dapagliflozin 10 mg, Green, plain, diamond shaped, film coated tablet (orally); Matching placebo for dapagliflozin Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 18, 2019
• Study Start: May 12, 2019
• Primary Completion: January 12, 2024
• Study Completion: May 23, 2024
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)