Study to evaluate the effect of dapagliflozin, exenatide and their combination on the loss of protein in urine in patients with type 2 diabetes

An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes - DECADE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004709-42-NL

Enrollment

Registered

2018-03-28

Start date

2018-04-24

Completion date

Unknown

Last updated

2018-05-07

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

Conditions

Type 2 diabetes

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Type 2 diabetes • HbA1c = 7.5% (58 mmol/mol) and 30 ml/min/1.73m2 • Albumin:creatinine ratio >3.5mg/mmol and =100 mg/mmol • Age = 18 years • RAS-blockade either by ACEI or ARB, or willingness to start ACEI or ARB treatment • Written informed consent 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 4 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13

Exclusion criteria

Exclusion criteria: • Pregnant women and women of child-bearing potential who are not using reliable contraception • Cardiovascular disease • Uncontrolled blood pressure (office bp > 160/ 100 mmHg) • Active malignancy • History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension) • Use of SGLT-2 inhibitor, GLP1-RA or DPP-4 inhibitor. • Lithium use

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes and elevated albuminuria (3.5-100 mg/mmol).;Primary end point(s): The primary outcome is the percentage change from baseline in albumin:creatinine ratio in the first morning void urine.;Timepoint(s) of evaluation of this end point: 6 weeks;Secondary Objective: Secondary objectives are to assess the correlation in albuminuria-lowering response of dapagliflozin and exenatide within each individual, to assess the effect of dapagliflozin, exenatide and their combination on extracellular volume, to evaluate the correlation between change in extracellular volume and effect on albuminuria, to assess the effect of dapagliflozin, exenatide and their combination on blood pressure and weight, and to evaluate the correlation between the pharmacokinetics of dapagliflozin and exenatide and their albumniria lowering effect.	—

Measure

Time frame

Main Objective: The main objective of this study is to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes and elevated albuminuria (3.5-100 mg/mmol).;Primary end point(s): The primary outcome is the percentage change from baseline in albumin:creatinine ratio in the first morning void urine.;Timepoint(s) of evaluation of this end point: 6 weeks;Secondary Objective: Secondary objectives are to assess the correlation in albuminuria-lowering response of dapagliflozin and exenatide within each individual, to assess the effect of dapagliflozin, exenatide and their combination on extracellular volume, to evaluate the correlation between change in extracellular volume and effect on albuminuria, to assess the effect of dapagliflozin, exenatide and their combination on blood pressure and weight, and to evaluate the correlation between the pharmacokinetics of dapagliflozin and exenatide and their albumniria lowering effect.

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Secondary

Measure	Time frame
Secondary end point(s): • Correlation in albuminuria response with each intervention • Change from baseline in extracellular volume • Change from baseline in fractional lithium excretion • Correlation between change in albuminuria and extracellular volume • Change in blood pressure • Change in weight • Assessment of pharmacokinetic parameters of each intervention ;Timepoint(s) of evaluation of this end point: 6 weeks	—

Measure

Time frame

Secondary end point(s): • Correlation in albuminuria response with each intervention • Change from baseline in extracellular volume • Change from baseline in fractional lithium excretion • Correlation between change in albuminuria and extracellular volume • Change in blood pressure • Change in weight • Assessment of pharmacokinetic parameters of each intervention ;Timepoint(s) of evaluation of this end point: 6 weeks

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Countries

Netherlands

Contacts

Public ContactClinical Trial Information

Martini Hospital

a.vd.aart@mzh.nl

Outcome results

None listed

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