Type 2 Diabetes Mellitus, CKD and AlbuminuriaPhase 2/3NCT02547935

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 study testing Dapagliflozin 10 mg and Saxagliptin 2.5 mg in people with Type 2 Diabetes Mellitus, CKD and Albuminuria, run by AstraZeneca at 112 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Type 2 Diabetes Mellitus, CKD and Albuminuria
What is being tested?: Dapagliflozin 10 mg and Saxagliptin 2.5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 459 participants
Where: 112 sitesin 9 countries
Study dates: 21 Sep 2015to 18 May 2018
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

112 sites in 9 countries.

Country

City, postcode or hospital

112 sites in 9 countries

United States37 sites

Research Site
Augusta, Georgia, 30909
Research Site
Bangor, Maine, 04401
Research Site
Brownsville, Texas, 78520
Research Site
Burke, Virginia, 22015
Research Site
Chicago, Illinois, 60643
Research Site
Chula Vista, California, 91910
Research Site
Concord, California, 94520
Research Site
Cypress, Texas, 77429
Research Site
El Centro, California, 92243
Research Site
Greensboro, North Carolina, 27408
Research Site
Greenville, South Carolina, 29605
Research Site
Hollywood, Florida, 33024
Research Site
Houston, Texas, 77004
Research Site
Kansas City, Missouri, 64111
Research Site
La Mesa, California, 92123
Research Site
Las Vegas, Nevada, 89148
Research Site
Long Beach, California, 90807
Research Site
Los Gatos, California, 95032
Research Site
Meridian, Idaho, 83642
Research Site
Miami, Florida, 33126
Research Site
Morehead City, North Carolina, 28557
Research Site
New Port Richey, Florida, 34652
Research Site
North Hollywood, California, 91606
Research Site
Palm Harbor, Florida, 34684
Research Site
Peoria, Arizona, 85381
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Pompano Beach, Florida, 33060
Research Site
Richmond, Virginia, 23219
Research Site
Riverside, California, 92505
Research Site
Rocky Mount, North Carolina, 27804
Research Site
Salt Lake City, Utah, 84124
Research Site
San Antonio, Texas, 78215
Research Site
San Diego, California, 92111
Research Site
San Dimas, California, 91773
Research Site
Springfield Gardens, New York, 11413
Research Site
Sugar Land, Texas, 77479
Research Site
The Bronx, New York, 10459

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Japan15 sites

Research Site
Chūōku, 103-0002
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 103-0028
Research Site
Hachioji-shi, 192-0071
Research Site
Higashiosaka-shi, 577-0803
Research Site
Kisarazu-shi, 292-0038
Research Site
Kyoto, 615-8125
Research Site
Neyagawa, 572-0015
Research Site
Nishinomiya-shi, 663-8113
Research Site
Ōita, 870-0039
Research Site
Osaka, 530-0001
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Osaka, 559-0012
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Sendai, 980-0021
Research Site
Shinjuku-ku, 160-0008
Research Site
Toyonaka-shi, 560-0082

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Mexico13 sites

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Aguascalientes, 20230
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Guadalajara, 44160
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Guadalajara, 44600
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Guadalajara, 44670
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México, 03300
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México, 03800
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México, 06726
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Monterrey, 64060
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Monterrey, 64460
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Monterrey, 64465
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Querétaro, 76000
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Zapopan, 45116
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Zapopan, Jalisco, 45200

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Canada11 sites

Research Site
Ajax, Ontario, L1Z 0M1
Research Site
Cambridge, Ontario, N1R 6V6
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Chicoutimi, Quebec, G7H 7K9
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Moncton, New Brunswick, E1G 1A7
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Québec, Quebec, G2J 0C4
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Saint-Jérôme, Quebec, J7Z 5T3
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Scarborough Village, Ontario, M1H 3G4
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Scarborough Village, Ontario, M1R 3A6
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Toronto, Ontario, M5C 2T2
Research Site
Winnipeg, Manitoba, R3E 3P4

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South Korea10 sites

Research Site
Ansan-si, 15355
Research Site
Busan, 47392
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Cheongju-si, 28644
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Daejeon, 35015
Research Site
Seongnam-si, 13620
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Seoul, 02841
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Seoul, 03080
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Seoul, 06351
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Suwon, 16499
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Wŏnju, 26426

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South Africa9 sites

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Benoni, 1501
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Cape Town, 1730
Research Site
Cape Town, 7925
Research Site
Durban, 4092
Research Site
Kuilsrivier, 7580
Research Site
Mamelodi East, 0184
Research Site
Muckleneuk, 0002
Research Site
Paarl, 7646
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Pretoria, 184

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Taiwan7 sites

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Changhua, 500
Research Site
Kaohsiung Hsien, 83342
Research Site
New Taipei City, 23148
Research Site
New Taipei City
Research Site
Taichung, 40705
Research Site
Taipei, 112
Research Site
Yongkang District, 71004

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Spain6 sites

Research Site
A Coruña, 15006
Research Site
Barcelona, 08035
Research Site
Madrid, 28046
Research Site
Sabadell (Barcelona), 08208
Research Site
Santiago(A Coruña), 15706
Research Site
Valencia, 46017

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Australia4 sites

Research Site
Box Hill, 3128
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Campbelltown, 2560
Research Site
Geelong, 3220
Research Site
Herston, 4029

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About this study

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

Conditions: Type 2 Diabetes Mellitus, CKD and Albuminuria
Being tested: Dapagliflozin 10 mg, Saxagliptin 2.5 mg, Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Medical subject headings: Diabetes Mellitus, Type 2, Albuminuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dapagliflozin 10 mgDrug
Also called Forxiga™
Tablets administered orally once daily for 24 weeks.
Saxagliptin 2.5 mgDrug
Also called Onglyza™
Tablets administered orally once daily for 24 weeks.
Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mgDrug
Tablets administered orally once daily for 24 weeks.

Study groups in NCT02547935
Study group	Role	What they receive
Dapagliflozin 10mg	Experimental	Tablets administered orally once daily for 24 weeks Receives: Drug: Dapagliflozin 10 mg
Dapagliflozin 10mg + Saxagliptin 2.5mg	Experimental	Tablets administered orally once daily for 24 weeks Receives: Drug: Saxagliptin 2.5 mg
Placebo	Placebo comparator	Tablets administered orally once daily for 24 weeks Receives: Drug: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and Week 24

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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]).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 201518 May 2018

First posted14 Sep 2015 (estimated)
Study start21 Sep 2015
Primary completion18 May 2018
Study completion18 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes Mellitus, CKD and AlbuminuriaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547935
Sponsor's protocol ID: D1690C00023
Status last verified: Jul 2019
First submitted: 31 Aug 2015
Last updated: 21 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 38770818
Koshino A, Neuen BL, Jongs N, Pollock C, Greasley PJ, Andersson EM, Hammarstedt A, Karlsson C, Langkilde AM, Wada T, Heerspink HJL. Effects of dapagliflozin and dapagliflozin-saxagliptin on erythropoiesis, iron and inflammation markers in patients with type 2 diabetes and chronic kidney disease: data from the DELIGHT trial. Cardiovasc Diabetol. 2023 Nov 28;22(1):330. doi: 10.1186/s12933-023-02027-8.
PubMed 38017482
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02547935
Acronym / sponsor ID: D1690C00023
Conditions: Type 2 Diabetes Mellitus, CKD and Albuminuria
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 21 Sep 2015 (actual)
Primary completion: 18 May 2018 (actual)
Study completion: 18 May 2018 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 4 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

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

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (14 listed)

Any of the following CV/Vascular Diseases within 3 month prior to signing the consent at Visit 1:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dapagliflozin 10 mgAlso: Forxiga™Tablets administered orally once daily for 24 weeks.	Drug	Dapagliflozin 10mg
Saxagliptin 2.5 mgAlso: Onglyza™Tablets administered orally once daily for 24 weeks.	Drug	Dapagliflozin 10mg + Saxagliptin 2.5mg
Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mgTablets administered orally once daily for 24 weeks.	Drug	Placebo

Primary outcome

Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
Time frame: Baseline and 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
Time frame: Baseline and 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.

6 secondary outcomes

Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24
Time frame: Baseline and Week 24
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24
Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24
Time frame: From baseline up to Week 24
Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24
Time frame: From baseline to Week 24
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24
Time frame: Baseline and Week 24
Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 4 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin 10 mg + Saxagliptin 2.5 mg	155	150
Dapagliflozin 10 mg	145	137
Placebo	148	143

Primary outcome: Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: Percentage of Glycoslyated HbA1c

Measure	Dapagliflozin 10 mg + Saxagliptin 2.5 mg n = 151	Placebo n = 145
Value	-0.85 (0.09)	-0.27 (0.09)

Dapagliflozin 10 mg + Saxagliptin 2.5 mg vs Placebo: Difference in adjusted mean change: -0.58 (95% CI -0.80 to -0.37), p <0.001, MMRM

Population analysed: Patients from the Full Analysis Set (all randomised patients who took at least 1 dose of double-blind study drug and had a non missing baseline value and at least one post-baseline efficacy variable value) with non-missing baseline and Week 24 values for HbA1c.

Primary outcome: Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: Percent change

Measure	Dapagliflozin 10 mg + Saxagliptin 2.5 mg n = 151	Dapagliflozin 10 mg n = 140	Placebo n = 144
Value	-39.1 (5.1)	-22.4 (6.6)	-1.8 (8.3)

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

Population analysed: Patients from the Full Analysis Set with non-missing baseline and Week 24 values for UACR.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin 10 mg + Saxagliptin 2.5 mg	12 of 152 (7.9%)	12 of 152 (7.9%)	1 of 152
Dapagliflozin 10 mg	12 of 145 (8.3%)	18 of 145 (12.4%)	1 of 145
Placebo	16 of 148 (10.8%)	8 of 148 (5.4%)	0 of 148

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38770818Natale 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.
Derived from this study: PubMed 38017482Koshino A, Neuen BL, Jongs N, Pollock C, Greasley PJ, Andersson EM, Hammarstedt A, Karlsson C, Langkilde AM, Wada T, Heerspink HJL. Effects of dapagliflozin and dapagliflozin-saxagliptin on erythropoiesis, iron and inflammation markers in patients with type 2 diabetes and chronic kidney disease: data from the DELIGHT trial. Cardiovasc Diabetol. 2023 Nov 28;22(1):330. doi: 10.1186/s12933-023-02027-8.
Derived from this study: PubMed 30992195Pollock 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.
D1690c00023\_CSP\_RedactedLink provided by the sponsor.
D1690c00023\_SAP\_RedactedLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

112 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dapagliflozin 10 mg and Saxagliptin 2.5 mg in people with Type 2 Diabetes Mellitus, CKD and Albuminuria, run by AstraZeneca at 112 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Japan, Mexico, Canada, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02547935, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.