Type II Diabetes Mellitus with Nephropathy and Albuminuria MedDRA version: 17.0 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Mitsubishi Tanabe Pharma Corporation (MTPC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female subjects aged 18 to 75 years who have been diagnosed with Type II diabetes mellitus according to the criteria of the WHO. -Subjects with a clinical diagnosis of diabetic nephropathy, who have been treated with ACE-I or ARB for a minimum of 12 weeks prior to screening and have been receiving a stable dose for at least 4 weeks prior to screening and remain on a stable dose up to baseline (Day 1 pre-dose). -Subjects with stable BP at Week -2 (compared with Week -4) and at baseline, Day 1 pre-dose (compared with Week -2). Stable BP is defined as a DBP within ± 10 mmHg from the previous BP measurement. Subjects must also have a DBP =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: -Central laboratory serum potassium level 5.2 mmol/L at screening, Week -2 or baseline (Day 1 pre-dose). -Local laboratory serum potassium level 5.2 mmol/L at baseline (Day 1 pre-dose). -Clinically significant abnormalities of the thyroid (hypo- or hyperthyroidism measured by thyroid stimulating hormone, free triiodothyronine and free thyroxine) at screening or Week -2, or subjects on thyroxine replacement therapy. -Subjects who are on both ARB and ACE-I. -History of hospitalisation for hyperkalemia or acute kidney injury induced by previous renin-angiotensin-aldosterone system blocker treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of multiple oral doses of MT-3995 in subjects with Type II diabetic nephropathy with albuminuria.;Secondary Objective: To evaluate the effects of multiple oral doses of MT-3995 on albuminuria as assessed by the urine albumin-to-creatinine ratio (UACR). To determine plasma concentrations of MT-3995 and its major metabolite (chlorinated metabolite: 1118174) after multiple oral doses of MT-3995 in subjects with Type II diabetic nephropathy with albuminuria. To determine the change from baseline in sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in subjects with Type II diabetic nephropathy with albuminuria.;Primary end point(s): Efficacy endpoint: -Within-group comparison of percentage change in first-morning UACR from baseline (median of three values on consecutive days prior to Day 1) to Week 8.;Timepoint(s) of evaluation of this end point: Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Percentage change in first-morning UACR from baseline (median of three values on consecutive days prior to Day 1) to Week 8 compared to placebo. -Change from baseline (Day 1 pre-dose) in sitting SBP/DBP to Weeks 1, 2, 4, 6 and 8 within group.;Timepoint(s) of evaluation of this end point: Various timepoints throughout the study - please refer to the detailed Time and Events Schedule in the protocol for full details | — |
Countries
Bulgaria, Hungary, Lithuania, Slovakia
Contacts
Public ContactGeneral Information
Mitsubishi Tanabe Pharma Europe Ltd (MTPE)
Outcome results
None listed