Evaluation of the Tubular Effects of Dapagliflozin Using 1HNMR Spectroscopy

NCT02798757 | Completed Phase 4

• 1 other identifier: ESR-14-10613 - D1690L00044
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase IV study that will explore the mechanisms of action of a drug (dapagliflozin) that is already commercially available in the country where the study will be conducted (Greece). The drug will be used according to its approved clinical indications (as add-on treatment in patients failed to achieve glycemic targets on metformin monotherapy) and in the approved posology (10 mg/day). Additionally, although there is limited data on the coadministration of dapagliflozin with thiazides, the excellent safety profile of the drug even when it is used in combination with drugs that induce significant volume depletion (such as loop diuretics) suggests that, in properly selected patients, the possibility of important adverse events during the coadministration of dapagliflozin with chlorthalidone is very low. All patients will give written informed consent prior to their enrollment in the study. The study protocol will be approved by the scientific committee of the University Hospital of Ioannina.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Composite outcome measure. % change to the concentrations of specific metabolites.

  % change in the concentrations of metabolites such as 1) glucose, creatinine, creatine, choline, taurine, dimethylamine, betaine, trimethylaminoxide 2) amino acids such as glycine, valine, alanine, leucine, histidine, lysine, threonine and 3) organic acids such as citrate, hippurate, lactate, acetate, succinate, and formate

  6 months

Study Arms (1)

Dapagliflozin

EXPERIMENTAL

All patients will take dapagliflozin, the intervention does not refer to a drug or device but to the specific 1HNMR test spectroscopy

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

Urine samples will be collected for 1HNMR spectroscopies

Dapagliflozin

Eligibility Criteria

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

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Female and/or male aged 18-70 years. Women with childbearing potential can only be included in the study if a serological pregnancy test is negative and a safe contraception method is used throughout the study.
• Uncontrolled type 2 diabetes mellitus (HbA1c \> 7%) on metformin monotherapy (≥ 2000 mg qd or maximum tolerated dose)
• Stage 1 hypertension (BP 140-159/90-99 mmHg)

You may not qualify if:

• Known primary kidney disease (eGFR \< 60 ml/min)
• History of cardiovascular disease
• Type 1 diabetes
• History of heart failure
• Diseases that shorten the life expectancy (cancers, degenerative neurological disorders etc.)
• Pregnancy-lactation
• Patients with eGFR values lower than 45 ml/min (on repeated measurements) during the study period will be excluded

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University of Ioannina

Ioannina, 45500, Greece

Location

Related Publications (2)

• Filippas-Ntekouan S, Dimou A, Dafopoulos P, Kostara C, Bairaktari E, Chasapi S, Spyroulias G, Koufakis T, Koutsovasilis A, Tsimihodimos V. Effect of dapagliflozin on the serum metabolome in patients with type 2 diabetes mellitus. J Diabetes Metab Disord. 2024 Dec 16;24(1):4. doi: 10.1007/s40200-024-01508-1. eCollection 2025 Jun.

  PMID: 39697865 DERIVED

• Bletsa E, Filippas-Dekouan S, Kostara C, Dafopoulos P, Dimou A, Pappa E, Chasapi S, Spyroulias G, Koutsovasilis A, Bairaktari E, Ferrannini E, Tsimihodimos V. Effect of Dapagliflozin on Urine Metabolome in Patients with Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1269-1283. doi: 10.1210/clinem/dgab086.

  PMID: 33592103 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 14, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: April 19, 2019

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)