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NCT Number: NCT02547935

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

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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Key information

Conditions

Type 2 Diabetes Mellitus, CKD and Albuminuria Albuminuria Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Research Site, Box Hill, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin 10 mg

Drug

Tablets administered orally once daily for 24 weeks.

Other names: Forxiga™

Saxagliptin 2.5 mg

Drug

Tablets administered orally once daily for 24 weeks.

Other names: Onglyza™

Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg

Drug

Tablets administered orally once daily for 24 weeks.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24

    Time frame: Baseline and 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.

  2. Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Time frame: Baseline and 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.

  3. Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24

    Time frame: From baseline up to 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]).

  4. Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24

    Time frame: From baseline to 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.

  5. Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24

    Time frame: Baseline and 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.

  6. Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 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 MMRM model.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2015
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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