A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
DERIVE
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III Study to Evaluate the Glycemic Efficacy and Renal Safety of Dapagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) Who Have Inadequate Glycemic Control.
1 other identifier
interventional
321
8 countries
87
Brief Summary
The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Jun 2015
Longer than P75 for phase_3 type-2-diabetes-mellitus
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 9, 2015
CompletedStudy Start
First participant enrolled
June 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2017
CompletedResults Posted
Study results publicly available
October 31, 2018
CompletedOctober 31, 2018
September 1, 2018
2.4 years
April 7, 2015
June 22, 2018
October 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m\^2). The "number analyzed" (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24.
Baseline, Week 24
Secondary Outcomes (3)
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
Baseline, Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
Baseline, Week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
Baseline, Week 24
Study Arms (2)
Dapagliflozin
EXPERIMENTAL10 mg Tablets, Oral, Once daily, 24 weeks
Placebo
PLACEBO COMPARATORMatching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
Interventions
Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Eligibility Criteria
You may qualify if:
- Female or male aged ≥18 years and \<75 years.
- 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
You may not qualify if:
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (87)
Research Site
Huntsville, Alabama, 35801, United States
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Burbank, California, 91505, United States
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Chula Vista, California, 91910, United States
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Concord, California, 94520, United States
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Fullerton, California, 92835-3404, United States
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Huntington Beach, California, 92648, United States
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Los Gatos, California, 95032, United States
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Newport Beach, California, 92663, United States
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Salinas, California, 93901-4446, United States
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Miami, Florida, 33015, United States
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Miami, Florida, 33144, United States
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Miami Springs, Florida, 33166, United States
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Pembroke Pines, Florida, 33027, United States
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Chicago, Illinois, 60643, United States
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Brownsburg, Indiana, 46112, United States
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Louisville, Kentucky, 40213, United States
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Monroe, Louisiana, 71203, United States
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Flint, Michigan, 48504, United States
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Jackson, Michigan, 39209, United States
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Chesterfield, Missouri, 63017, United States
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Kansas City, Missouri, 64111, United States
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Chapel Hill, North Carolina, 27517, United States
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Chattanooga, Tennessee, 37404, United States
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Houston, Texas, 77004, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78224, United States
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Manassas, Virginia, 20110, United States
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Blagoevgrad, 2700, Bulgaria
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Botevgrad, 2140, Bulgaria
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Kozloduy, 3320, Bulgaria
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Kyustendil, 2500, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1606, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Red Deer, Alberta, T4N 6V7, Canada
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Surrey, British Columbia, V3S 2N6, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Brampton, Ontario, L6S 0S9, Canada
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Cambridge, Ontario, N1R 6V6, Canada
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Concord, Ontario, L4K 4M2, Canada
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Courtice, Ontario, L1E 3C3, Canada
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Etobicoke, Ontario, M9R 4E1, Canada
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Greater Sudbury, Ontario, P3E 6C3, Canada
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Guelph, Ontario, N1H 1B1, Canada
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London, Ontario, N6G 5A9, Canada
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North York, Ontario, M3J 1N2, Canada
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Oakville, Ontario, L6M 4H8, Canada
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Toronto, Ontario, M3M 0B2, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Québec, Quebec, G1V 4G2, Canada
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Saskatoon, Saskatchewan, S7H 5M3, Canada
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Cheb, 350 02, Czechia
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Hořovice, 268 01, Czechia
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Krnov, 794 01, Czechia
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Kutná Hora, 284 30, Czechia
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Ostrava, 702 00, Czechia
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Prague, 104 00, Czechia
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Praha Klanovice, 190 14, Czechia
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Bari, 70124, Italy
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Bergamo, 24127, Italy
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Chieti Scalo, 66013, Italy
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Milan, 20122, Italy
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Napoli, 80138, Italy
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Padua, 35128, Italy
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Pisa, 56100, Italy
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San Giovanni Rotondo, 71013, Italy
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Bielsko-Biala, 43-300, Poland
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Bydgoszcz, 85-231, Poland
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Lodz, 90-132, Poland
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Mrągowo, 11-700, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Tczew, 83-110, Poland
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Wroclaw, 50-403, Poland
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A Coruña, 15006, Spain
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Alicante, 03010, Spain
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Ferrol, 15405, Spain
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La Laguna (Tenerife), 38320, Spain
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Lleida, 25198, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Málaga, 29010, Spain
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Pozuelo de Alarcón, 28223, Spain
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Gothenburg, 413 45, Sweden
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Lund, 221 85, Sweden
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Stockholm, 111 57, Sweden
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Stockholm, 11324, Sweden
Related Publications (2)
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.
PMID: 38770818DERIVEDFioretto 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.
PMID: 29888547DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anna Maria Langkilde, MD PhD
- Organization
- Global Clinical Leader-Dapagliflozin AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2015
First Posted
April 9, 2015
Study Start
June 15, 2015
Primary Completion
November 7, 2017
Study Completion
November 7, 2017
Last Updated
October 31, 2018
Results First Posted
October 31, 2018
Record last verified: 2018-09