EUCTR2015-000335-32-DK
Active, Not Recruiting
Phase 1
Effects of dapagliflozin treatment on urinary proteomic patterns in patients with type 2 diabetes - DapKid
ConditionsDiabetes type 2 and albuminuriaMedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
DrugsForxiga
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetes type 2 and albuminuria
- Sponsor
- Steno Diabetes Center
- Enrollment
- 40
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients \>18 years of age with a diagnosis of type 2 diabetes (WHO criteria).
- •Patients must be on current stable antiglycaemic treatment with oral drugs (OAD) or insulin 4 weeks before start of study drug and throughout study duration.
- •Patients must be on stable antihypertensive treatment (must include renin\-angiotensin system blocking treatment) 4 weeks before start of study drug and throughout study duration.
- •HbA1c \>7\.5 %
- •Urinary albumin creatinine ratio (UACR) \> 30 mg/g (in \=2 out 3 morning spot urine collections prior to randomisation).
- •eGFR \= 45 ml/min/1\.73 m2
- •Stable RAAS\-blocking treatment (more than or equal to 4 weeks prior to visit 0\) If not stable at visit 0, screening phase can be prolonged to 4 weeks.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Current treatment with loop diuretics
- •Current treatment with thiazolidinediones
- •Current treatment with dapagliflozin or other SGLT2 inhibitor
- •Ongoing cancer treatment
- •Patients on hypertension treatment who are is not on stable antihypertensive treatment (must include renin\-angiotensin system blocking treatment) 4 weeks before start of study drug and throughout study duration
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN
- •Total bilirubin \>2\.0 mg/dL (34\.2 µmol/L)
- •Positive serologic evidence of current infectious liver disease including, Hepatitis B surface antigen and antibody and Hepatitis C virus antibody
- •eGFR: \<45 mL/min (calculated by MDRD formula)
- •History of unstable or rapidly progressing renal disease
Outcomes
Primary Outcomes
Not specified
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