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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02547935




Registration number
NCT02547935
Ethics application status
Date submitted
31/08/2015
Date registered
14/09/2015
Date last updated
21/08/2019

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
D1690C00023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus, CKD and Albuminuria 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dapagliflozin 10 mg
Treatment: Drugs - Saxagliptin 2.5 mg
Treatment: Drugs - Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

Experimental: Dapagliflozin 10mg - Tablets administered orally once daily for 24 weeks

Experimental: Dapagliflozin 10mg + Saxagliptin 2.5mg - Tablets administered orally once daily for 24 weeks

Placebo Comparator: Placebo - Tablets administered orally once daily for 24 weeks


Treatment: Drugs: Dapagliflozin 10 mg
Tablets administered orally once daily for 24 weeks.

Treatment: Drugs: Saxagliptin 2.5 mg
Tablets administered orally once daily for 24 weeks.

Treatment: Drugs: Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg
Tablets administered orally once daily for 24 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Primary outcome [2] 0 0
Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24
Timepoint [3] 0 0
From baseline up to Week 24
Secondary outcome [4] 0 0
Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24
Timepoint [4] 0 0
From baseline to Week 24
Secondary outcome [5] 0 0
Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24
Timepoint [6] 0 0
Baseline and Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2018
Sample size
Target
Accrual to date
Final
459
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Campbelltown
Recruitment hospital [3] 0 0
Research Site - Geelong
Recruitment hospital [4] 0 0
Research Site - Herston
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment outside Australia
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Missouri
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Nevada
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Utah
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Virginia
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Manitoba
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New Brunswick
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Ontario
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Quebec
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Muckleneuk
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Paarl
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Pretoria
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Barcelona
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Sabadell (Barcelona)
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Valencia
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Kaohsiung Hsien
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Taipei City
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Yong-Kang City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT02547935
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02547935