CKD3 patients with type 2 diabetes mellitus and albuminuria. MedDRA version: 18.0 Level: LLT Classification code 10045250 Term: Type II diabetes mellitus with renal manifestations System Organ Class: 100000004857
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female or male aged > o = 18 years and o = 7.5% and =65 years) yes F.1.3.1 Number of subjects for this age range 225
Exclusion criteria
Exclusion criteria: Main exclusion criteria are:- History of ?2 major hypoglycaemic events in the 3 months prior to enrolment visit, defined as symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with blood glucose level <3.0 mmol/L, <54 mg/dL (plasma glucose level <3.5 mmol/L, <63 mg/dL) and prompt recovery after glucose or glucagon administration.- Patients with Type 1 DM, history of diabetes insipidus, diabetic ketoacidosis, hyperosmolar nonketotic coma- Severe uncontrolled hypertension or any CV/Vascular Diseases within 3 month prior to signing the following: - Myocardial infarction. - Cardiac surgery or revascularization.- Unstable angina.- Unstable heart failure.- HF New York Heart Association Class III-IV.- Transient ischemic attack or significant cerebrovascular disease.- Unstable or previously undiagnosed arrhythmia.-Significant hepatic disease, severe hepatobiliary disease or hepatotoxicity with any medication- History of haemoglobinopathy or acute kidney injury requiring renal replacement therapy or any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.- History of unexplained microscopic or gross haematuria, or microscopic haematuria, confirmed by a follow-up sample at next scheduled visit- Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors.- Simultaneous treatment with both an ACEi and an ARB- A metformin dose which is outside the specified dose range for moderate renal impairment (eGFR 30-59 mL/minute/1.73 m^2,) according to local guidelines and investigators judgement.- Any condition which, in the ju gment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk or suspected risk to the patient or with confirmed poor protocol or medication compliance - Patients at risk for volume depletion as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives for the Saxagliptin/Dapagliflozin treatment arm - To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3.- To compare the mean percent change from baseline in urine albumin-to creatinine ratio (UACR) between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3. Primary objective for the Dapagliflozin treatment arm. - To compare the mean percent change from baseline in urine albumin-to creatinine ratio (UACR) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3.;Secondary Objective: ·To compare the mean percent change from baseline in total body weight, and to compare the mean change from baseline in fasting plasma glucose or seated systolic blood pressure between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo. ·To compare the proportion of patients achieving a 30% reduction in Urine albumin-to-creatinine ratio or a reduction in HbA1c <7.0% between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo. ·To compare the mean percent change from baseline in total body weight and to compare the mean change from basleine in seated systolic blood pressure, HbA1c, or fasting plasma glucose between dapagliflozin 10 mg and placebo. ·To compare the proportion of patients achieving a 30% reduction in Urine albumin-to-creatinine ratio or a reduction in HbA1c <7.0% between dapagliflozin 10 mg and placebo.;Primary end point(s): Outcome Measure for the Saxagliptin/Dapagliflozin treatment arm?Change from baseline in HbA1c at Week 24.- Percent change from baseline in UACR at Week 24 Outcome Measure for the Dapagliflozin treatment arm.- Percent change from | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Outcome Measure for the Saxagliptin/Dapagliflozin treatment arm: 1. Percent change from baseline in total body weight at Week 24 2. Change from baseline in FPG at Week 24 3. 30% reduction in UACR at Week 24 4. HbA1c < 7.0 % at Week 24 5. Change from baseline in seated SBP at Week 24 Outcome Measure for the Dapagliflozin treatment arm: 1. Percent change from baseline in total body weight at Week 24 2. 30% reduction in UACR at Week 24 3. Change from baseline in seated SBP at Week 24 4. Change from baseline in HbA1c at Week 24 5. Change from baseline in FPG at Week 24 6. HbA1c < 7.0 % at Week 24;Timepoint(s) of evaluation of this end point: Baseline to the end of treatment | — |
Countries
Australia, Canada, Japan, Mexico, Spain, Taiwan, United States
Contacts
Public ContactUnidad de Investigación Clínica
AstraZeneca Farmacéutica Spain, S.A.
Outcome results
None listed