Clinical trial NCT02413398: A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
timeFrame: Baseline, Week 24
measure: Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
timeFrame: Baseline, Week 24
measure: Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Burbank
country: United States
facility: Research Site
state: California
city: Chula Vista
country: United States
facility: Research Site
state: California
city: Concord
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Los Gatos
country: United States
facility: Research Site
state: California
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Salinas
country: United States
facility: Research Site
state: California
city: Miami Springs
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Brownsburg
country: United States
facility: Research Site
state: Indiana
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Monroe
country: United States
facility: Research Site
state: Louisiana
city: Flint
country: United States
facility: Research Site
state: Michigan
city: Jackson
country: United States
facility: Research Site
state: Michigan
city: Chesterfield
country: United States
facility: Research Site
state: Missouri
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Manassas
country: United States
facility: Research Site
state: Virginia
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Botevgrad
country: Bulgaria
facility: Research Site
city: Kozloduy
country: Bulgaria
facility: Research Site
city: Kyustendil
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Red Deer
country: Canada
facility: Research Site
state: Alberta
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: Concord
country: Canada
facility: Research Site
state: Ontario
city: Courtice
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Guelph
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: North York
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Cheb
country: Czechia
facility: Research Site
city: Horovice
country: Czechia
facility: Research Site
city: Krnov
country: Czechia
facility: Research Site
city: Kutna Hora
country: Czechia
facility: Research Site
city: Ostrava
country: Czechia
facility: Research Site
city: Praha - Klanovice
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Chieti Scalo
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: San Giovanni Rotondo
country: Italy
facility: Research Site
city: Bielsko-Biała
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Mrągowo
country: Poland
facility: Research Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Research Site
city: Tczew
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: A Coruña
country: Spain
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Ferrol
country: Spain
facility: Research Site
city: La Laguna (Tenerife)
country: Spain
facility: Research Site
city: Lérida
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Pozuelo de Alarcon
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
References:
citation: 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.