Back to resultsA Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes (DERIVE)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin 10 mg
Matching Placebo for Dapagliflozin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dapagliflozin
Placebo
Arm Description
10 mg Tablets, Oral, Once daily, 24 weeks
Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
To compare the mean percent change from baseline in total body weight 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" represents the number with change from baseline available at Week 24.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
To compare the mean change from baseline in FPG 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" represents the number with change from baseline available at Week 24.
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
To compare the mean change from baseline in seated systolic blood pressure (SBP) 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" represents the number with change from baseline available at Week 24.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02413398
Brief Title
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Acronym
DERIVE
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 15, 2015 (Actual)
Primary Completion Date
November 7, 2017 (Actual)
Study Completion Date
November 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
10 mg Tablets, Oral, Once daily, 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo to Dapagliflozin 10 mg tablet. Oral, Once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 mg
Other Intervention Name(s)
Farxiga™
Intervention Description
Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
Intervention Type
Drug
Intervention Name(s)
Matching Placebo for Dapagliflozin
Intervention Description
Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
Description
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.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.
Description
To compare the mean percent change from baseline in total body weight 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" represents the number with change from baseline available at Week 24.
Time Frame
Baseline, Week 24
Title
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.
Description
To compare the mean change from baseline in FPG 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" represents the number with change from baseline available at Week 24.
Time Frame
Baseline, Week 24
Title
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.
Description
To compare the mean change from baseline in seated systolic blood pressure (SBP) 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" represents the number with change from baseline available at Week 24.
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Research Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Research Site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Research Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-3404
Country
United States
Facility Name
Research Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Research Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Research Site
City
Salinas
State/Province
California
ZIP/Postal Code
93901-4446
Country
United States
Facility Name
Research Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
Research Site
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Research Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Research Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Research Site
City
Jackson
State/Province
Michigan
ZIP/Postal Code
39209
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Research Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Research Site
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Research Site
City
Botevgrad
ZIP/Postal Code
2140
Country
Bulgaria
Facility Name
Research Site
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Facility Name
Research Site
City
Kyustendil
ZIP/Postal Code
2500
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Research Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Research Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Research Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3S 2N6
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6S 0S9
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Research Site
City
Concord
State/Province
Ontario
ZIP/Postal Code
L4K 4M2
Country
Canada
Facility Name
Research Site
City
Courtice
State/Province
Ontario
ZIP/Postal Code
L1E 3C3
Country
Canada
Facility Name
Research Site
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Research Site
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 1B1
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 5A9
Country
Canada
Facility Name
Research Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M3J 1N2
Country
Canada
Facility Name
Research Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6M 4H8
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 6C3
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3M 0B2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7H 5M3
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Research Site
City
Cheb
ZIP/Postal Code
350 02
Country
Czechia
Facility Name
Research Site
City
Horovice
ZIP/Postal Code
268 01
Country
Czechia
Facility Name
Research Site
City
Krnov
ZIP/Postal Code
794 01
Country
Czechia
Facility Name
Research Site
City
Kutna Hora
ZIP/Postal Code
284 30
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Research Site
City
Praha - Klanovice
ZIP/Postal Code
190 14
Country
Czechia
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
104 00
Country
Czechia
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Research Site
City
Chieti Scalo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Research Site
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Research Site
City
Bielsko-Biała
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-231
Country
Poland
Facility Name
Research Site
City
Mrągowo
ZIP/Postal Code
11-700
Country
Poland
Facility Name
Research Site
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Research Site
City
Tczew
ZIP/Postal Code
83-110
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
50-403
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-132
Country
Poland
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Research Site
City
Ferrol
ZIP/Postal Code
15405
Country
Spain
Facility Name
Research Site
City
La Laguna (Tenerife)
ZIP/Postal Code
38320
Country
Spain
Facility Name
Research Site
City
Lérida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
111 57
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
11324
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
29888547
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. Erratum In: Diabetes Obes Metab. 2019 Jan;21(1):203.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3689&filename=D1690C00024-Clinical%20Study%20Protocol-v%204.0_redacted_final_1.pdf
Description
Redacted Study Protocol
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3689&filename=D1690C00024-Statistical-Analysis-Plan-Edition-2_redacted_final_PDF_A.pdf
Description
Redacted SAP
Learn more about this trial
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
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