Efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAglipti

Phase 1

Active, not recruiting

Conditions: Type 2 diabetes patients receiving current standard therapy for diabetic nephropathy (ACEi or ARB) with micro- or macroalbuminuria (UACR between 30 and 3000 mg/g creatinine). [ACEi=Angiotensin Converting Enzyme inhibitor
ARB=Angiotensin Receptor Blocker
UACR= Urinary Albumin Creatinine Ratio]
MedDRA version: 14.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-002603-17-ES

Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 404

Inclusion Criteria

?Diagnosis of type 2 diabetes mellitus
?7%? HbA1c ? 10%
?Current standard therapy for diabetic nephropathy at stable dose for 10 weeks
?Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening.
?Estimated glomerular filtration rate, eGFR ? 30 ml/min.
?Age ?18 years but ? 80 years at Screening.
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 364
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

?Dual or triple blockade of the Renin Angiotensin System (RAS)
?Uncontrolled hyperglycaemia
?Mean arterial blood pressure > 110 mmHg
?Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos).
?Treatment with a glitazone within 6 months prior to informed consent.
?Treatment with a DPP-4 inhibitor, a GLP-1 agonist, a SGLT2 inhibitor, a dopamin-agonist, a bile-acid sequestrant or insulin (except basal insulin) within 10 weeks prior to informed consent.
?Treatment with anti-obesity drugs 10 weeks prior to informed consent.
?Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
?Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
?Participation in another trial with an investigational drug within 2 months prior to informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the current study is to investigate the glycemic efficacy and safety of linagliptin 5 mg given orally once daily for 24 weeks to type 2 diabetes patients with albuminuria (urinary albumin-to-creatinine ratio 30-3000 mg/g creatinine) on top of current standard therapy for diabetic nephropathy (ACEi or ARB).;Secondary Objective: As a key secondary aim the study will adress anti-albuminuric potentials of linagliptin in patients at early stages of diabetic nephropathy with micro- or macroalbuminuria.;Primary end point(s): The primary endpoint is the change from baseline in HbA1c;Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The key secondary endpoint is the time weighted average of percentage change from baseline in UACR;Timepoint(s) of evaluation of this end point: 24 weeks