Back to resultsA 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
Primary Purpose
Type 2 Diabetes Mellitus, CKD and Albuminuria
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dapagliflozin 10 mg
Saxagliptin 2.5 mg
Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus, CKD and Albuminuria
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- 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:
Any of the following CV/Vascular Diseases within 3 month prior to signing the consent at Visit 1:
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dapagliflozin 10mg
Dapagliflozin 10mg + Saxagliptin 2.5mg
Placebo
Arm Description
Tablets administered orally once daily for 24 weeks
Tablets administered orally once daily for 24 weeks
Tablets administered orally once daily for 24 weeks
Outcomes
Primary Outcome Measures
Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model.
Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24
UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.
Secondary Outcome Measures
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24
Total body weight was measured in kilograms (kg) at baseline and at Week 1 then every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. Total body weight values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
FPG was analysed at baseline and Week 1 then every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.
Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24
The percentage of patients meeting the criteria of at least a 30% reduction in UACR, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (Last Observation Carried Forward [LOCF]).
Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24
The percentage of patients meeting the criteria of a less than 7% reduction in HbA1c, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (LOCF). Only measurements prior to rescue or treatment discontinuation were analysed.
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24
Seated SBP was analysed at baseline, Week 1 and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.
Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24
HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02547935
Brief Title
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
Official Title
An Exploratory Phase II/III, Randomized, Double-blind, Placebo Controlled, Parallel Design Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Dapagliflozin and Dapagliflozin in Combination With Saxagliptin in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria Treated With ACEi or ARB
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 21, 2015 (Actual)
Primary Completion Date
May 18, 2018 (Actual)
Study Completion Date
May 18, 2018 (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 alone or in combination with saxagliptin can decrease albuminuria and improve glycemic control in patients with Type 2 diabetes, albuminuria and renal impairment (CKD). The study is planned to randomize a total of 450 patients (150 patients per treatment arm)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, CKD and Albuminuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
459 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapagliflozin 10mg
Arm Type
Experimental
Arm Description
Tablets administered orally once daily for 24 weeks
Arm Title
Dapagliflozin 10mg + Saxagliptin 2.5mg
Arm Type
Experimental
Arm Description
Tablets administered orally once daily for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tablets administered orally once daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 mg
Other Intervention Name(s)
Forxiga™
Intervention Description
Tablets administered orally once daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Saxagliptin 2.5 mg
Other Intervention Name(s)
Onglyza™
Intervention Description
Tablets administered orally once daily for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Intervention Description
Tablets administered orally once daily for 24 weeks.
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
Description
HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model.
Time Frame
Baseline and Week 24
Title
Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24
Description
UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24
Description
Total body weight was measured in kilograms (kg) at baseline and at Week 1 then every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. Total body weight values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.
Time Frame
Baseline and Week 24
Title
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Description
FPG was analysed at baseline and Week 1 then every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.
Time Frame
Baseline and Week 24
Title
Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24
Description
The percentage of patients meeting the criteria of at least a 30% reduction in UACR, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (Last Observation Carried Forward [LOCF]).
Time Frame
From baseline up to Week 24
Title
Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24
Description
The percentage of patients meeting the criteria of a less than 7% reduction in HbA1c, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (LOCF). Only measurements prior to rescue or treatment discontinuation were analysed.
Time Frame
From baseline to Week 24
Title
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24
Description
Seated SBP was analysed at baseline, Week 1 and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.
Time Frame
Baseline and Week 24
Title
Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24
Description
HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.
Time Frame
Baseline and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
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:
Any of the following CV/Vascular Diseases within 3 month prior to signing the consent at Visit 1:
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
Facility Information:
Facility Name
Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
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
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Research Site
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
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Research Site
City
La Mesa
State/Province
California
ZIP/Postal Code
92123
Country
United States
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Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
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Research Site
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Research Site
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
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Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
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Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
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Research Site
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
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Research Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
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Research Site
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Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
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Research Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
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United States
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Research Site
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
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United States
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Research Site
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
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United States
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Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
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United States
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Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
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Research Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
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United States
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Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
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Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
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Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Research Site
City
Springfield Gardens
State/Province
New York
ZIP/Postal Code
11413
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Research Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Research Site
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Research Site
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78520
Country
United States
Facility Name
Research Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
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
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Research Site
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
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Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Research Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Research Site
City
Campbelltown
ZIP/Postal Code
2560
Country
Australia
Facility Name
Research Site
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Research Site
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
Research Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1G 1A7
Country
Canada
Facility Name
Research Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1H 3G4
Country
Canada
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1R 3A6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Research Site
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Research Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0002
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Research Site
City
Hachioji-shi
ZIP/Postal Code
192-0071
Country
Japan
Facility Name
Research Site
City
Higashiosaka-shi
ZIP/Postal Code
577-0803
Country
Japan
Facility Name
Research Site
City
Kisarazu-shi
ZIP/Postal Code
292-0038
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
ZIP/Postal Code
615-8125
Country
Japan
Facility Name
Research Site
City
Neyagawa-shi
ZIP/Postal Code
572-0015
Country
Japan
Facility Name
Research Site
City
Nishinomiya-shi
ZIP/Postal Code
663-8113
Country
Japan
Facility Name
Research Site
City
Oita-shi
ZIP/Postal Code
870-0039
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
559-0012
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0021
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Research Site
City
Toyonaka-shi
ZIP/Postal Code
560-0082
Country
Japan
Facility Name
Research Site
City
Ansan-si
ZIP/Postal Code
15355
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju-si
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Research Site
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
03800
Country
Mexico
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Research Site
City
Monterey
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64465
Country
Mexico
Facility Name
Research Site
City
México
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Research Site
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Research Site
City
Zapopan, Jalisco
ZIP/Postal Code
45200
Country
Mexico
Facility Name
Research Site
City
Zapopan
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Research Site
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
1730
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4092
Country
South Africa
Facility Name
Research Site
City
Kuilsrivier
ZIP/Postal Code
7580
Country
South Africa
Facility Name
Research Site
City
Mamelodi East
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Research Site
City
Muckleneuk
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Research Site
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
184
Country
South Africa
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Sabadell (Barcelona)
ZIP/Postal Code
08208
Country
Spain
Facility Name
Research Site
City
Santiago(A Coruña)
ZIP/Postal Code
15706
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Research Site
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung Hsien
ZIP/Postal Code
83342
Country
Taiwan
Facility Name
Research Site
City
New Taipei City
ZIP/Postal Code
23148
Country
Taiwan
Facility Name
Research Site
City
New Taipei
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Yong-Kang City
ZIP/Postal Code
71004
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
30992195
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3763&filename=D1690c00023_CSP_Redacted.pdf
Description
D1690c00023_CSP_Redacted
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3763&filename=D1690c00023_SAP_Redacted.pdf
Description
D1690c00023_SAP_Redacted
Learn more about this trial
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
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