Prediction and prevention of kidney disease in patients with diabetes

Phase 1

• Conditions: Patients with type 2 diabetes mellitus and normoalbuminuria; MedDRA version: 19.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-000452-34-NL
• Lead Sponsor: Steno Diabetes Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 2000

Inclusion Criteria

• Written informed consent must be provided before participation.
Patient information and consent form must be approved by relevant
independent EC. Specifically, all participating patients will be asked to
give informed consent for long-term follow-up and collection of followup
data
• Male or female patients = 18 years and < 75 years of age at Screening
visit
• Type 2 DM (WHO criteria)
• Persistent normoalbuminuria (at least 2 of 3 UACR < 30 mg/g samples
from run in period)
• eGFR > 45 ml/min/1.73m2 at Screening visit
• The patient must be willing and able to comply with the protocol for
the duration of the study
• Female without child-bearing potential at the screening visit. Defined
as one or more of following:
- Female patients = 50 years of age at the day of inclusion, who have
been postmenopausal for at least 1 year
- Female patients < 50 years of age at the day of inclusion, who have
been postmenopausal for at least 1 year and serum FSH levels > 40
mIU/mL as well as serum estrogen levels < 30 pg/ml or a negative
estrogen test
- 6 weeks after surgical sterilization by bilateral tubal ligation or
bilateral ovariectomy with or without hysterectomy
OR a negative urine pregnancy test at the Screening visit AND one or
more of the following:
- Correct use of reliable contraception methods. This includes one or
more ofthe following: hormonal contraceptive (such as injection,
transdermal patch, implant, cervical ring or oral) or an intrauterine
device (IUD) OR correct use of double barrier with one of the following:
barrier methods (diaphragm, cervical cap, Lea contraceptive, femidom or
condom) AND in combination with a spermicide
- General sexual abstinence from the time of screening, during the study
until a minimum of 30 days after the last administration of study
medication if this is already established as the patient's preferred and
usual lifestyle.
- Having only female sexual partners
- Sexual relationship with sterile male partners only

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 660
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1340

Exclusion Criteria

• Average of systolic BP < 110 or > 160 mm Hg at baseline
• Average of diastolic BP > 100 mm Hg at baseline
• Type 1 DM (WHO criteria)
• HbA1c <6.5% (48 mmo l/ mol) AND > 5 years of known duration of diabetes type 2 AND never treated with a antidiabetic drug of any kind.
• Current in treatment with more than one RAAS blocking agent (Angiotensin Converting Enzyme inhibitor, Angiotensin Receptor Blocker or Direct Renin Inhibitor)
• Current lithium treatment (ATC: N05AN)
• Known or suspected hypersensitivity to Spironolactone or to any of its excipients
• Current use of potassium sparing diuretics (ATC: C03D, C03E), such as: Spironolactone, Eplerenone or amiloride etc
• Hyperkalemia at Screening: plasma potassium level >5.0 mmol/L or serum potassium level >5.4 mmol/L.
• Hyponatriemia determine by the investigator
• Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer)
• Any clinically significant disorder, except for conditions as-sociated with type 2 DM history, which in the Investigators opinion could interfere with the results of the trial
• Cardiac disease defined as: Heart failure (NYHA class III-IV) and/or diagnosis of unstable angina pectoris and/or MI, stroke, PTCA or CABG within the last 3 months
• Diagnosis of non-Diabetic CKD current or in the past
• Diagnosis of liver cirrhosis with current impaired liver function within the last 3 years.
• Diagnosis of Addison's disease
• Being lactating
• Intend to become pregnant within the duration of the study or not use adequate birth control.
• Known or suspected abuse of alcohol or narcotics
• Not able to understand informed consent form
• Participation in any other intervention trial than PRIORITY or a related sub-study is not allowed within 30 days before inclusion or concurrent to this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified