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
NCT ID: NCT02547935
Last Updated: 2019-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
459 participants
INTERVENTIONAL
2015-09-21
2018-05-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
NCT02413398
ESR-15-11293 - Saxa/Dapa, Safety and Efficacy Study
NCT02613897
The Study Will Evaluate Average 24-hr Sodium Excretion During Dapagliflozin Treatment in Patients With Type 2 Diabetes Mellitus With Preserved or Impaired Renal Function or Non-diabetics With Impaired Renal Function.
NCT03152084
Dapagliflozin Treatment in Type 2 Diabetes
NCT04620590
A Clinical Study to Investigate the Effects of Dapagliflozin on Heart Work, Heart Nutrient Uptake, and Heart Muscle Efficiency in Type 2 Diabetes Patients
NCT03387683
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dapagliflozin 10mg
Tablets administered orally once daily for 24 weeks
Dapagliflozin 10 mg
Tablets administered orally once daily for 24 weeks.
Dapagliflozin 10mg + Saxagliptin 2.5mg
Tablets administered orally once daily for 24 weeks
Saxagliptin 2.5 mg
Tablets administered orally once daily for 24 weeks.
Placebo
Tablets administered orally once daily for 24 weeks
Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Tablets administered orally once daily for 24 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dapagliflozin 10 mg
Tablets administered orally once daily for 24 weeks.
Saxagliptin 2.5 mg
Tablets administered orally once daily for 24 weeks.
Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Tablets administered orally once daily for 24 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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 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
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Peoria, Arizona, United States
Research Site
Chula Vista, California, United States
Research Site
Concord, California, United States
Research Site
El Centro, California, United States
Research Site
La Mesa, California, United States
Research Site
Long Beach, California, United States
Research Site
Los Gatos, California, United States
Research Site
North Hollywood, California, United States
Research Site
Riverside, California, United States
Research Site
San Diego, California, United States
Research Site
San Dimas, California, United States
Research Site
Hollywood, Florida, United States
Research Site
Miami, Florida, United States
Research Site
New Port Richey, Florida, United States
Research Site
Palm Harbor, Florida, United States
Research Site
Pompano Beach, Florida, United States
Research Site
Augusta, Georgia, United States
Research Site
Meridian, Idaho, United States
Research Site
Chicago, Illinois, United States
Research Site
Bangor, Maine, United States
Research Site
Kansas City, Missouri, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Springfield Gardens, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Greensboro, North Carolina, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Rocky Mount, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Research Site
Brownsville, Texas, United States
Research Site
Cypress, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Sugar Land, Texas, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Burke, Virginia, United States
Research Site
Richmond, Virginia, United States
Research Site
Box Hill, , Australia
Research Site
Campbelltown, , Australia
Research Site
Geelong, , Australia
Research Site
Herston, , Australia
Research Site
Winnipeg, Manitoba, Canada
Research Site
Moncton, New Brunswick, Canada
Research Site
Ajax, Ontario, Canada
Research Site
Cambridge, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Jérôme, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Chūōku, , Japan
Research Site
Chūōku, , Japan
Research Site
Chūōku, , Japan
Research Site
Hachioji-shi, , Japan
Research Site
Higashiosaka-shi, , Japan
Research Site
Kisarazu-shi, , Japan
Research Site
Kyoto, , Japan
Research Site
Neyagawa, , Japan
Research Site
Nishinomiya-shi, , Japan
Research Site
Osaka, , Japan
Research Site
Osaka, , Japan
Research Site
Ōita, , Japan
Research Site
Sendai, , Japan
Research Site
Shinjuku-ku, , Japan
Research Site
Toyonaka-shi, , Japan
Research Site
Aguascalientes, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
México, , Mexico
Research Site
México, , Mexico
Research Site
México, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Querétaro, , Mexico
Research Site
Zapopan, , Mexico
Research Site
Zapopan, Jalisco, , Mexico
Research Site
Benoni, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Kuilsrivier, , South Africa
Research Site
Mamelodi East, , South Africa
Research Site
Muckleneuk, , South Africa
Research Site
Paarl, , South Africa
Research Site
Pretoria, , South Africa
Research Site
Ansan-si, , South Korea
Research Site
Busan, , South Korea
Research Site
Cheongju-si, , South Korea
Research Site
Daejeon, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Suwon, , South Korea
Research Site
Wŏnju, , South Korea
Research Site
A Coruña, , Spain
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Sabadell (Barcelona), , Spain
Research Site
Santiago(A Coruña), , Spain
Research Site
Valencia, , Spain
Research Site
Changhua, , Taiwan
Research Site
Kaohsiung Hsien, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Yongkang District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Koshino A, Neuen BL, Jongs N, Pollock C, Greasley PJ, Andersson EM, Hammarstedt A, Karlsson C, Langkilde AM, Wada T, Heerspink HJL. Effects of dapagliflozin and dapagliflozin-saxagliptin on erythropoiesis, iron and inflammation markers in patients with type 2 diabetes and chronic kidney disease: data from the DELIGHT trial. Cardiovasc Diabetol. 2023 Nov 28;22(1):330. doi: 10.1186/s12933-023-02027-8.
Pollock C, Stefansson B, Reyner D, Rossing P, Sjostrom CD, Wheeler DC, Langkilde AM, Heerspink HJL. Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):429-441. doi: 10.1016/S2213-8587(19)30086-5. Epub 2019 Apr 13.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D1690C00023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.