Investigation of the renal effects of dapagliflozin regarding potential protective effects on renal function, by analysis of urine samples utilizing a method called nuclear magnetic resonance spectroscopy, used to identify molecules.

Evaluation of the tubular effects of dapagliflozin using 1HNMR spectroscopy.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003873-13-GR

Enrollment

Registered

2015-10-23

Start date

2016-02-25

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2. MedDRA version: 18.1 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Forxiga Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Dapagliflozin CAS Number: 960404-48-2 Other descriptive name: DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. 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. 3. Uncontrolled type 2 diabetes mellitus (HbA1c > 7%) on metformin monotherapy (= 2000 mg qd or maximum tolerated dose) 4. Stage 1 hypertension (BP 140-159/90-99 mmHg) 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: 1. Known primary kidney disease (eGFR < 60 ml/min) 2. History of cardiovascular disease 3. Type 1 diabetes 4. History of heart failure 5. Diseases that shorten the life expectancy (cancers, degenerative neurological disorders etc.) 6. Pregnancy-lactation 7. Patients with eGFR values lower than 45 ml/min (on repeated measurements) during the study period will be excluded

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize the effect of dapagliflozin on the renal tubular function using 1HNMR spectroscopy. ;Secondary Objective: Secondary objectives: To assess the effects of the coadministration of dapagliflozin with chlorothalidone on the extracellular volume status and electrolyte concentrations in diabetic patients with hypertension. The doses of blood pressure-lowering drugs for controlling BP (< 140/90 mmHg) will be assessed at the end of the dapagliflozin monotherapy period and at the end of the dapagliflozin-chlorothalidone coadministration period. Safety objective: Safety monitoring will be performed at monthly intervals. On each visit, the presence of adverse events will be assessed by history, detailed physical examination and appropriate laboratory tests. Exploratory objectives: As NMR spectroscopy is a non-selective technique, novel, unexpected, metabolites related to the disease process can be revealed and identified from their characteristic spectrum. The drug-induced changes in the concentrations of these metabolites will be recorded and the mechanisms that underlie them will be investigated.;Primary end point(s): To characterize the effect of dapagliflozin on the renal tubular function using 1HNMR spectroscopy. ;Timepoint(s) of evaluation of this end point: At baseline, at week 13 and week 17.	—

Measure

Time frame

Main Objective: To characterize the effect of dapagliflozin on the renal tubular function using 1HNMR spectroscopy. ;Secondary Objective: Secondary objectives: To assess the effects of the coadministration of dapagliflozin with chlorothalidone on the extracellular volume status and electrolyte concentrations in diabetic patients with hypertension. The doses of blood pressure-lowering drugs for controlling BP (< 140/90 mmHg) will be assessed at the end of the dapagliflozin monotherapy period and at the end of the dapagliflozin-chlorothalidone coadministration period. Safety objective: Safety monitoring will be performed at monthly intervals. On each visit, the presence of adverse events will be assessed by history, detailed physical examination and appropriate laboratory tests. Exploratory objectives: As NMR spectroscopy is a non-selective technique, novel, unexpected, metabolites related to the disease process can be revealed and identified from their characteristic spectrum. The drug-induced changes in the concentrations of these metabolites will be recorded and the mechanisms that underlie them will be investigated.;Primary end point(s): To characterize the effect of dapagliflozin on the renal tubular function using 1HNMR spectroscopy. ;Timepoint(s) of evaluation of this end point: At baseline, at week 13 and week 17.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary objectives: To assess the effects of the coadministration of dapagliflozin with chlorothalidone on the extracellular volume status and electrolyte concentrations in diabetic patients with hypertension. In addition, the doses of blood pressure-lowering drugs needed to control BP values (< 140/90 mmHg) will be assessed at the end of the dapagliflozin monotherapy period as well as at the end of the dapagliflozin-chlorothalidone coadministration period. Safety objective: Safety monitoring will be performed at monthly intervals. On each visit, the presence of adverse events will be assessed by history, detailed physical examination and appropriate laboratory tests (glucose, uric acid, urea, creatinine, electrolytes, complete blood count and urinalysis). In addition, patients will be instructed to contact the study personnel in case of an emergency situation, whereas an adverse event reporting system will be available throughout the study. In the case of a serious adverse event requiring hospitalization the participant will be excluded from the study. Exploratory objectives: As NMR spectroscopy is a non-selective technique, novel, unexpected, metabolites related to the disease process can be revealed and identified from their characteristic spectrum. The drug-induced changes in the concentrations of these metabolites will be recorded and the mechanisms that underlie them will be investigated.;Timepoint(s) of evaluation of this end point: Secondary: according to the timepoint of collection of each specific variable (e.g. at weeks 5, 9, 13, 17) as applicable. Safety: data collection and assessment of assessment are continuous. The safety data will be analyzed at the end of the study.	—

Measure

Time frame

Secondary end point(s): Secondary objectives: To assess the effects of the coadministration of dapagliflozin with chlorothalidone on the extracellular volume status and electrolyte concentrations in diabetic patients with hypertension. In addition, the doses of blood pressure-lowering drugs needed to control BP values (< 140/90 mmHg) will be assessed at the end of the dapagliflozin monotherapy period as well as at the end of the dapagliflozin-chlorothalidone coadministration period. Safety objective: Safety monitoring will be performed at monthly intervals. On each visit, the presence of adverse events will be assessed by history, detailed physical examination and appropriate laboratory tests (glucose, uric acid, urea, creatinine, electrolytes, complete blood count and urinalysis). In addition, patients will be instructed to contact the study personnel in case of an emergency situation, whereas an adverse event reporting system will be available throughout the study. In the case of a serious adverse event requiring hospitalization the participant will be excluded from the study. Exploratory objectives: As NMR spectroscopy is a non-selective technique, novel, unexpected, metabolites related to the disease process can be revealed and identified from their characteristic spectrum. The drug-induced changes in the concentrations of these metabolites will be recorded and the mechanisms that underlie them will be investigated.;Timepoint(s) of evaluation of this end point: Secondary: according to the timepoint of collection of each specific variable (e.g. at weeks 5, 9, 13, 17) as applicable. Safety: data collection and assessment of assessment are continuous. The safety data will be analyzed at the end of the study.

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Countries

Greece

Contacts

Public ContactVasilis Tsimihodimos

2nd Department of Internal Medicine, University General Hospital of Ioannina

tsimiho@gmail.com302651099846

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026