EUCTR2015-000804-24-ITActive, not recruitingPhase 1
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase III study to Evaluate the Glycemic Efficacy and Renal Safety of dapagliflozin in patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment (CKD 3A) who have Inadequate Glycemic Control
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 321
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1, Female or male aged =18 years and <75 years.
- •2, History of T2DM for more than 12 months.
- •3, Inadequate glycemic control, defined as HbA1c =7.0% and =11% measured at Screening. Note that HbA1c will be rechecked at Visit 4, and must then be =7.0 and =10.5% (value from blood sample obtained at Visit 3) for patient to be randomized.
- •4, Stable anti-diabetic treatment regimen, defined as stable diet and exercise therapy alone or in combination with any or both of the two following alternatives:
- •A regimen of any approved oral anti-diabetic medication (except SGLT2-inhibitors) where no dose-changes have occurred during 12 weeks before randomization
- •Long acting or intermediate acting insulin and mixed insulin permitted as long as the dose is stable during last 12 weeks before randomization, changes ± 10% are allowed (in relation to number of units at randomization).
- •5, Renal impairment: CKD 3A
- •eGFR* 40 – 65 mL/minute/1.73 m2 at Visit 2 (value from blood sample obtained at Visit 1) to enter the lead-in period.
- •eGFR* 45 – 59 mL/minute/1.73 m2 at Visit 4 (average value calculated from the eGFR values at Visit 2 and Visit 3) for randomization.
- •*according to the re-expressed abbreviated (four-variable) MDRD Study equation, using central laboratory measurements of serum creatinine(sCr). [eGFR (mL/min/1.73m2) = 175 x (standardized sCr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if Black)] [Note: sCr reported in mg/dL]
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 151
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 151
Exclusion Criteria
- •1, Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
- •2, Women who are pregnant or breastfeeding.
- •3, Aspartate Aminotransferase (AST) >3X ULN.
- •4, Alanine Aminotransferase (ALT) >3X ULN.
- •5, Total Bilirubin (TB) >2 mg/dL (35 µmol/L).
- •6, Serum Potassium (K) >5.5 meq/L (5.5 mmol/L).
- •7, Serum Calcium (Ca) <8 mg/dL or > ULN (<1.99 mmol/L or > ULN).
- •8, Positive for hepatitis B surface antigen.
- •9, Positive for anti-hepatitis C virus antibody.
- •10, Hemoglobin =9.0 g/dL (90 g/L).
- •11, History of diabetes insipidus.
- •12, Symptoms of poorly controlled diabetes that would preclude participation in this study including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the three months prior to signing the consent at visit 1, or other signs and symptoms.
- •13, History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- •14, History of =2 major hypoglycemic events in the 3 months prior to enrolment, defined as symptomatic events requiring external assistance due to severe impairment in consciousness or behaviour, with blood glucose level <3.0 mmol/L, <54 mg/dL (plasma glucose level <3.5 mmol/L, <63 mg/dL) and prompt recovery after glucose or glucagon administration.
- •15, Severe uncontrolled hypertension defined as SBP =180 mmHg and/or DBP =110 mmHg at any visit up to randomization.
- •17, Any of the following CV/Vascular Diseases within 3 months of prior to signing the consent at visit 1:Myocardial infarction, Cardiac surgery or revascularization (CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.
- •18, History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
- •19, History of renal transplant.
- •20, Hemodialysis, ultrafiltration therapy, or peritoneal dialysis within 6 months prior to signing the consent at visit 1.
- •21, Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
- •22, Documented history of hepatotoxicity with any medication.
- •23, Documented history of severe hepatobiliary disease.
- •24, Malignancy within 5 years of the enrolment visit (with the exception of treated basal cell or treated squamous cell carcinoma).
- •25, Known immunocompromised status, including but not limited to, individuals who have undergone organ transplantation or who are positive for the human immunodeficiency virus (HIV).
- •26, History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 2.
- •27, Long term treatment with glucocorticoids (two temporary periods of no longer than 10 days each are allowed during the study); topical or inhaled corticosteroids are allowed.
- •28, A metformin dose which is outside the specified dose range for moderate renal impairment (eGFR 30– 59 mL/minute/1.73m2, MDRD formula) according to local guidelines and investigator’s judgement.
- •29, Ongoing treatment with any SGLT2-inhibitor at screening.
- •30, History of bariatric surgery or lap-band procedure.
- •31, Administration of sibutramine, phentermine, orlistat, rimonabant, benzphetamine, diethylpropion, methamphetamine, Victoza (liraglutide)
Investigators
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