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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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D1690C00023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus, CKD and Albuminuria
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and Week 24
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Primary outcome [2]
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Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [1]
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Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24
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Assessment method [1]
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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.
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Timepoint [1]
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Secondary outcome [2]
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Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
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Assessment method [2]
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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.
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Timepoint [2]
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Secondary outcome [3]
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Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24
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Assessment method [3]
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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 \[LOCF\]).
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Timepoint [3]
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From baseline up to Week 24
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Secondary outcome [4]
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Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24
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Assessment method [4]
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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.
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Timepoint [4]
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Secondary outcome [5]
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Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and Week 24
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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
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Minimum age
18
Years
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Maximum age
130
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/09/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/05/2018
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Sample size
Target
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Accrual to date
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Final
459
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Box Hill
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Research Site - Campbelltown
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Research Site - Geelong
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Research Site - Herston
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3128 - Box Hill
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Recruitment postcode(s) [2]
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2560 - Campbelltown
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3220 - Geelong
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
Ethics application status
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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)
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Trial website
https://clinicaltrials.gov/study/NCT02547935
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/35/NCT02547935/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/35/NCT02547935/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02547935
Download to PDF