CompletedNCT02547935Updated Aug 21, 2019Results posted

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

A Phase 2/3 interventional study of Dapagliflozin 10 mg and Saxagliptin 2.5 mg in Type 2 Diabetes Mellitus, CKD and Albuminuria, sponsored by AstraZeneca. Completed at 112 sites in 9 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2019-08-21.

Sponsored by AstraZeneca · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 459
Allocation: Randomized
Ages: 18 Years to 130 Years
Sex: All

Study 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)

Conditions studied

Type 2 Diabetes Mellitus, CKD and Albuminuria

Browse trials for

In context

Albuminuria

121 studies on the registry are indexed under Albuminuria; 21 are open to participants now.

This study's enrollment of 459 is above the median of 73 across 96 interventional studies indexed under Albuminuria.

Browse Albuminuria studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 130 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 459 participants (actual)

Study arms

Experimental
Dapagliflozin 10mg
Tablets administered orally once daily for 24 weeks
Drug: Dapagliflozin 10 mg
Experimental
Dapagliflozin 10mg + Saxagliptin 2.5mg
Tablets administered orally once daily for 24 weeks
Drug: Saxagliptin 2.5 mg
Placebo comparator
Placebo
Tablets administered orally once daily for 24 weeks
Drug: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

Interventions

DrugDapagliflozin 10 mg
Tablets administered orally once daily for 24 weeks.
Also known as: Forxiga™
DrugSaxagliptin 2.5 mg
Tablets administered orally once daily for 24 weeks.
Also known as: Onglyza™
DrugMatching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Tablets administered orally once daily for 24 weeks.

What researchers measure

Primary outcomes

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.
Time frame: Baseline and Week 24
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.
Time frame: Baseline and Week 24

Secondary outcomes

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.
Time frame: Baseline and 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.
Time frame: Baseline and Week 24
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 \[LOCF\]).
Time frame: From baseline up to Week 24
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.
Time frame: From baseline to Week 24
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.
Time frame: Baseline and Week 24
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.
Time frame: Baseline and Week 24

Results

Posted Jun 4, 2019

Limitations and caveats

Anomalous data at 1 site was identified following completion of the study. All data from this site were excluded from the full analysis following an audit; the findings led the sponsor to believe the site did not comply with the principles of GCP.

Participant flow

Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus with micro- or macro-albuminuria and treated with ACEi or ARB were enrolled into an international, multi-centre study from 21 Sep 2015. The last patient's last visit was 18 May 2018.

Participant flow — Overall Study
Milestone	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
Started	155	145	148
Received treatment	152	145	148
Full analysis set	152	144	148
Safety analysis set	152	145	148
Completed	150	137	143
Not completed	5	8	5
Withdrew: Other	0	1	0
Withdrew: Withdrawal by subject	2	3	4
Withdrew: Screen failure	2	0	0
Withdrew: Physician decision	0	1	0
Withdrew: Lost to follow-up	0	2	1
Withdrew: Death	1	1	0

Outcome measures

PrimaryAdjusted 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.

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percentage of Glycoslyated HbA1c

Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
Percentage of Glycoslyated HbA1c	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Placebo
Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24	-0.85 ± 0.09	-0.27 ± 0.09

Statistical analysis

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo · MMRM · p = <0.001 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -0.58 · 95% CI -0.80 to -0.37

PrimaryAdjusted 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.

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent change

Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24
Percent change	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24	-39.1 ± 5.1	-22.4 ± 6.6	-1.8 ± 8.3

Statistical analysis

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo · MMRM · p = <0.001 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -38.0 · 95% CI -48.2 to -25.8
Dapagliflozin 10 mg vs Placebo · MMRM · p = 0.011 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -21.0 · 95% CI -34.1 to -5.2

SecondaryAdjusted 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.

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent change

Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24
Percent change	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24	-0.65 ± 0.55	-1.48 ± 0.56	-0.61 ± 0.56

Statistical analysis

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo · MMRM · p = 0.953 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -0.04 · 95% CI -1.32 to 1.26
Dapagliflozin 10 mg vs Placebo · MMRM · p = 0.193 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -0.87 · 95% CI -2.17 to 0.44

SecondaryAdjusted 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.

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · mg/decilitre (dL)

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
mg/decilitre (dL)	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	-17.2 ± 5.2	-13.1 ± 5.4	-11.2 ± 5.5

Statistical analysis

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo · MMRM · p = 0.298 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -6.1 · 95% CI -17.5 to 5.4
Dapagliflozin 10 mg vs Placebo · MMRM · p = 0.746 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -1.9 · 95% CI -13.6 to 9.8

SecondaryPercentage 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 \[LOCF\]).

Time frame:: From baseline up to Week 24
Reported as:: Number · Percentage of patients

Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24
Percentage of patients	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24	57.0	45.0	31.3

Statistical analysis

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo · Regression, Logistic · p = <0.001 (Statistical significance level = 0.025.) · Odds ratio (or): 2.98 · 95% CI 1.8 to 4.8
Dapagliflozin 10 mg vs Placebo · Regression, Logistic · p = 0.013 (Statistical significance level = 0.025.) · Odds ratio (or): 1.86 · 95% CI 1.1 to 3.0

SecondaryPercentage 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.

Time frame:: From baseline to Week 24
Reported as:: Number · Percentage of patients

Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24
Percentage of patients	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24	35.1	15.0	10.3

Statistical analysis

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo · Regression, Logistic · p = <0.001 (Statistical significance level = 0.025.) · Odds ratio (or): 5.43 · 95% CI 2.6 to 11.2
Dapagliflozin 10 mg vs Placebo · Regression, Logistic · p = 0.167 (Statistical significance level = 0.025.) · Odds ratio (or): 1.74 · 95% CI 0.8 to 3.8

SecondaryAdjusted 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.

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Millimetre of mercury (mmHg)

Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24
Millimetre of mercury (mmHg)	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24	-8.8 ± 1.6	-6.9 ± 1.7	-4.1 ± 1.7

Statistical analysis

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo · MMRM · p = 0.009 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -4.8 · 95% CI -8.3 to -1.2
Dapagliflozin 10 mg vs Placebo · MMRM · p = 0.122 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -2.8 · 95% CI -6.4 to 0.8

SecondaryAdjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percentage of Glycoslyated HbA1c

Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24
Percentage of Glycoslyated HbA1c	Dapagliflozin 10 mg	Placebo
Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24	-0.43 ± 0.09	-0.27 ± 0.09

Statistical analysis

Dapagliflozin 10 mg vs Placebo · MMRM · p = 0.142 (Statistical significance level = 0.025.) · Difference in adjusted mean change: -0.16 · 95% CI -0.38 to 0.05

Adverse events

Collected over Adverse events (AEs) are reported from Day 1 of the 24-week double-blind treatment period. Non-serious AEs were included up to the last day of double-blind treatment + 4 days. Serious AEs were included up to the last day of double-blind treatment + 30 days, giving a total maximum time frame of 28 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dapagliflozin 10 mg + Saxagliptin 2.5 mg	1/152 (0.7%)	12/152 (7.9%)	12/152 (7.9%)
Dapagliflozin 10 mg	1/145 (0.7%)	12/145 (8.3%)	18/145 (12.4%)
Placebo	0/148 (0%)	16/148 (10.8%)	8/148 (5.4%)

Most frequent serious events

Showing 10 of 40

Most frequent serious events
Event	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
SyncopeNervous system disorders	0/152	2/145	0/148
Angina pectorisCardiac disorders	0/152	1/145	2/148
Myocardial infarctionCardiac disorders	0/152	0/145	2/148
Ankle fractureInjury, poisoning and procedural complications	0/152	0/145	2/148
Cerebrovascular accidentNervous system disorders	0/152	0/145	2/148
Acute kidney injuryRenal and urinary disorders	0/152	0/145	2/148
HypoglycaemiaMetabolism and nutrition disorders	2/152	0/145	1/148
Cardiac failureCardiac disorders	0/152	1/145	0/148
Ventricular extrasystolesCardiac disorders	0/152	1/145	0/148
DiarrhoeaGastrointestinal disorders	0/152	1/145	0/148

Most frequent other events

Most frequent other events
Event	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo
NasopharyngitisInfections and infestations	10/152	10/145	6/148
InfluenzaInfections and infestations	2/152	8/145	2/148

Baseline characteristics

Baseline characteristics are presented for all randomised patients.

Age, Continuous
Age, Continuous(years)	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo	Total
Mean	64.0 ± 9.21	64.7 ± 8.61	64.7 ± 8.53	64.4 ± 8.78

Age, Customized
Age, Customized(Participants)	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo	Total
<65 years	78	64	68	210
>=65 years	77	81	80	238

Sex: Female, Male
Sex: Female, Male(Participants)	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo	Total
Female	45	43	43	131
Male	110	102	105	317

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo	Total
Hispanic or Latino	42	32	38	112
Not Hispanic or Latino	113	113	110	336
Unknown or Not Reported	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Dapagliflozin 10 mg + Saxagliptin 2.5 mg	Dapagliflozin 10 mg	Placebo	Total
White	77	55	64	196
Black or African American	8	7	11	26
Asian	57	67	53	177
Native Hawaiian or other Pacific Islander	1	2	1	4
American Indian or Alaska Native	0	1	1	2
Other	12	13	18	43

Study locations

112 sites

Research Site
Peoria, Arizona 85381, United States
Research Site
Chula Vista, California 91910, United States
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Concord, California 94520, United States
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El Centro, California 92243, United States
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La Mesa, California 92123, United States
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Long Beach, California 90807, United States
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Los Gatos, California 95032, United States
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North Hollywood, California 91606, United States
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Riverside, California 92505, United States
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San Diego, California 92111, United States
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San Dimas, California 91773, United States
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Hollywood, Florida 33024, United States
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Miami, Florida 33126, United States
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New Port Richey, Florida 34652, United States
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Palm Harbor, Florida 34684, United States
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Pompano Beach, Florida 33060, United States
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Augusta, Georgia 30909, United States
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Meridian, Idaho 83642, United States
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Chicago, Illinois 60643, United States
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Bangor, Maine 04401, United States
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Kansas City, Missouri 64111, United States
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Las Vegas, Nevada 89148, United States
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Bronx, New York 10459, United States
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Springfield Gardens, New York 11413, United States
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Greensboro, North Carolina 27408, United States
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Morehead City, North Carolina 28557, United States
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Rocky Mount, North Carolina 27804, United States
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Philadelphia, Pennsylvania 19107, United States
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Greenville, South Carolina 29605, United States
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Brownsville, Texas 78520, United States
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Cypress, Texas 77429, 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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Sugar Land, Texas 77479, United States
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Salt Lake City, Utah 84124, United States
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Burke, Virginia 22015, United States
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Richmond, Virginia 23219, United States
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Box Hill, 3128, Australia
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Campbelltown, 2560, Australia
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Geelong, 3220, Australia
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Herston, 4029, Australia
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Winnipeg, Manitoba R3E 3P4, Canada
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Moncton, New Brunswick E1G 1A7, Canada
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Ajax, Ontario L1Z 0M1, Canada
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Cambridge, Ontario N1R 6V6, Canada
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Scarborough, Ontario M1H 3G4, Canada
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Scarborough, Ontario M1R 3A6, Canada
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Toronto, Ontario M5C 2T2, Canada
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Chicoutimi, Quebec G7H 7K9, Canada
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Saint-Jerome, Quebec J7Z 5T3, Canada
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Sherbrooke, Quebec J1H 5N4, Canada
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Quebec, G2J 0C4, Canada
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Chuo-ku, 103-0002, Japan
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Chuo-ku, 103-0027, Japan
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Chuo-ku, 103-0028, Japan
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Hachioji-shi, 192-0071, Japan
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Higashiosaka-shi, 577-0803, Japan
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Kisarazu-shi, 292-0038, Japan
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Kyoto-shi, 615-8125, Japan
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Neyagawa-shi, 572-0015, Japan
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Nishinomiya-shi, 663-8113, Japan
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Oita-shi, 870-0039, Japan
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Osaka-shi, 530-0001, Japan
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Osaka-shi, 559-0012, Japan
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Sendai-shi, 980-0021, Japan
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Shinjuku-ku, 160-0008, Japan
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Toyonaka-shi, 560-0082, Japan
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Ansan-si, 15355, Korea, Republic of
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Busan, 47392, Korea, Republic of
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Cheongju-si, 28644, Korea, Republic of
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Daejeon, 35015, Korea, Republic of
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Seongnam-si, 13620, Korea, Republic of
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Seoul, 02841, Korea, Republic of
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Seoul, 03080, Korea, Republic of
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Seoul, 06351, Korea, Republic of
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Suwon-si, 16499, Korea, Republic of
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Wonju-si, 26426, Korea, Republic of
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Aguascalientes, 20230, Mexico
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Guadalajara, 44160, Mexico
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Guadalajara, 44600, Mexico
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Guadalajara, 44670, Mexico
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Mexico, 03800, Mexico
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Mexico, 06726, Mexico
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Monterey, 64060, Mexico
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Monterrey, 64460, Mexico
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Monterrey, 64465, Mexico
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México, 03300, Mexico
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Queretaro, 76000, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Zapopan, 45116, Mexico
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Benoni, 1501, South Africa
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Cape Town, 1730, South Africa
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Cape Town, 7925, South Africa
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Durban, 4092, South Africa
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Kuilsrivier, 7580, South Africa
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Mamelodi East, 0184, South Africa
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Muckleneuk, 0002, South Africa
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Paarl, 7646, South Africa
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Pretoria, 184, South Africa
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A Coruña, 15006, Spain

Showing the first 100 of 112 sites across 9 countries.

References and documents

Publications

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. PubMed 30992195 ↗

Study documents

Study protocol · Sep 18, 2017
Statistical analysis plan · Jun 5, 2018

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02547935
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Sep 14, 2015
Start date: Sep 21, 2015
Primary completion: May 18, 2018
Completion: May 18, 2018
Results posted: Jun 4, 2019
Last update: Aug 21, 2019

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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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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Albuminuria

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