A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and … (NCT02547935) | Clinical Trial Compass
CompletedPhase 2/3
A Study to Evaluate the Effect of Dapagliflozin With and Without Saxagliptin on Albuminuria, and to Investigate the Effect of Dapagliflozin and Saxagliptin on HbA1c in Patients With Type 2 Diabetes and CKD
United States, Australia, Canada459 participantsStarted 2015-09-21
Plain-language summary
The purpose of this clinical research study is to determine whether dapagliflozin alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures
* Female or male aged ≥18 years
* History of type 2 diabetes mellitus for more than 12 months
* HbA1c≥7.0% and ≤11.0%
* Stable antidiabetic treatment during the last 12 weeks up to randomization
* eGFR 25-75 mL/minute/1.73m2, inclusive
* Micro or macroalbuminuria (UACR 30 - 3500 mg/g)
* Treatment with ACE inhibitor or an ARB for at least 3 months prior to screening
* Body mass index between 20 and 45 kg/m2
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) \>2 mg/dL (34.2 μmol/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 whi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
Timeframe: Baseline and Week 24
2
Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24