DELIGHT

An Exploratory Phase 2/3, Randomized, Double-blind, Placebo Controlled, Parallel Design Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Dapagliflozin and Dapagliflozin in Combination With Saxagliptin in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria Treated With ACEi or ARB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223076

Enrollment

Registered

2016-01-14

Start date

2016-02-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Type 2 Diabetes Mellitus, CKD and Albuminuria

Interventions

investigational material(s) Generic name etc : Dapagliflozin 10 mg, Dapagliflozin 10mg+Saxagliptin 2.5mg INN of investigational material : dapagliflozin Therapeutic category code : 396 Antidiabetic ag

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Provision of informed consent prior to any study specific procedures - History of type 2 diabetes mellitus for more than 12 months - HbA1c 7.0% or more and less than 11.0% - Stable antidiabetic treatment during the last 12 weeks up to randomization - eGFR 25-75mL/minute/1.73m2, inclusive - Micro or macroalbuminuria (UACR 30 - 3500mg/g) - Treatment with ACE inhibitor or an ARB for at least 3 months prior to screening - Body mass index between 20 and 45kg/m2

Exclusion criteria

Exclusion criteria: - Any of the following CV/Vascular Diseases within 3 month prior to signing the consent at Visit 1 - Myocardial infarction - cardiac surgery or revascularization (CABG/PTCA) - unstable angina - unstable HF - New York Heart Association (NYHA) Class III-IV - transient ischemic attack (TIA) or significant cerebrovascular disease - unstable or previously undiagnosed arrhythmia - Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency - Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 3X ULN - Total Bilirubin (TB) >2mg/dL (34.2 micro mol/L) - History of acute kidney injury requiring renal replacement therapy (dialysis or ultrafiltration) or any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis - Ongoing treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors - Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance

Design outcomes

Primary

Measure	Time frame
safety efficacy exploratory -	—

Secondary

Measure	Time frame
safety efficacy exploratory -	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026