A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
NCT ID: NCT02413398
Last Updated: 2018-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2015-06-15
2017-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dapagliflozin
10 mg Tablets, Oral, Once daily, 24 weeks
Dapagliflozin 10 mg
Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Placebo
Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
Matching Placebo for Dapagliflozin
Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Interventions
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Dapagliflozin 10 mg
Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Matching Placebo for Dapagliflozin
Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of T2DM for more than 12 months.
* Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
* Stable anti-diabetic treatment regimen
* Renal impairment: CKD 3A
Exclusion Criteria
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
* Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
* Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:
Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
* History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
* Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
* Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
* Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
18 Years
74 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Huntsville, Alabama, United States
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Burbank, California, United States
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Chula Vista, California, United States
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Concord, California, United States
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Fullerton, California, United States
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Huntington Beach, California, United States
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Los Gatos, California, United States
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Newport Beach, California, United States
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Salinas, California, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Springs, Florida, United States
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Pembroke Pines, Florida, United States
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Chicago, Illinois, United States
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Brownsburg, Indiana, United States
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Louisville, Kentucky, United States
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Monroe, Louisiana, United States
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Flint, Michigan, United States
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Jackson, Michigan, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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Chapel Hill, North Carolina, United States
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Chattanooga, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Manassas, Virginia, United States
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Blagoevgrad, , Bulgaria
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Botevgrad, , Bulgaria
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Kozloduy, , Bulgaria
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Kyustendil, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Red Deer, Alberta, Canada
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Surrey, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Cambridge, Ontario, Canada
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Concord, Ontario, Canada
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Courtice, Ontario, Canada
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Etobicoke, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Guelph, Ontario, Canada
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London, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Cheb, , Czechia
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Hořovice, , Czechia
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Krnov, , Czechia
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Kutná Hora, , Czechia
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Ostrava, , Czechia
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Prague, , Czechia
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Praha Klanovice, , Czechia
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Bari, , Italy
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Bergamo, , Italy
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Chieti Scalo, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pisa, , Italy
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San Giovanni Rotondo, , Italy
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Bielsko-Biala, , Poland
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Bydgoszcz, , Poland
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Lodz, , Poland
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Mrągowo, , Poland
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Ostrowiec Świętokrzyski, , Poland
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Tczew, , Poland
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Wroclaw, , Poland
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A Coruña, , Spain
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Alicante, , Spain
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Ferrol, , Spain
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La Laguna (Tenerife), , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Pozuelo de Alarcón, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
Countries
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References
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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.
Fioretto P, Del Prato S, Buse JB, Goldenberg R, Giorgino F, Reyner D, Langkilde AM, Sjostrom CD, Sartipy P; DERIVE Study Investigators. Efficacy and safety of dapagliflozin in patients with type 2 diabetes and moderate renal impairment (chronic kidney disease stage 3A): The DERIVE Study. Diabetes Obes Metab. 2018 Nov;20(11):2532-2540. doi: 10.1111/dom.13413. Epub 2018 Jul 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D1690C00024
Identifier Type: -
Identifier Source: org_study_id
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