A study in which patients with type 2 diabetes and who have been told they have a certain type of protein, albumin, in their urine, are given orally GKT137831 or placebo, no active, to determine whether GKT137831 has any effect in these patients and it is safe

• Conditions: Patients with type 2 diabetes and albuminuria.; MedDRA version: 17.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 17.1Level: PTClassification code 10001580Term: AlbuminuriaSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-002507-34-CZ
• Lead Sponsor: Genkyotex Innovation SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-06
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Male or female aged 18 to 80 years, inclusive.
2. Willing and able to give written informed consent and to comply with
the requirements of the study.
3. History of type 2 diabetes, defined as fasting plasma glucose > or
equal to 7.0 mmol/L (126 mg/dL) or a glycated
hemoglobin (HbA1c) >6.5% (48 mmol/mol) on at least 2 occasions prior
to screening. If the diagnosis of type 2 diabetes has been made before
30 years of age, an optional fasting C-peptide level will be obtained
during the second screening visit (Visit 2) and must be > or equal to 0.1
ng/mL to confirm type 2 diabetes.
4. Albuminuria defined as a urinary albumin to creatinine ratio (UACR)
of:
- (a) 300 to 3500 mg/g (33.9 to 395.5 mg/mmol) during the screening
period to be eligible to enter the run-in period, determined as described
in the Methodology section.
- (b) 200 to 3500 mg/g ( 22.6 to 395.5 mg/mmol) by Week-2 (Visit 4) of
the run-in period to be eligible to enter the double-blind treatment
period, determined as described in the Methodology section.
5. An eGFR > or equal to 30 mL/min/1.73 m2, as calculated by the
CKD-EPI formula.
6. Must be taking an ACEI or an ARB for at least 6 weeks prior to the first
screening visit (Visit 1) and during the screening period. The dose must
have been stable for at least 4 weeks prior to the first screening visit
(Visit 1). Combination therapy associating an ACEI and an ARB is not
permitted.
7. Willing to practice highly effective methods of birth control (both
males who have partners of childbearing potential and females of
childbearing potential) during the screening period and the run-in
period, while taking investigational product and for at least 90 days
since the last dose of investigational product is ingested. Women of
childbearing potential are female patients who are not surgically sterile
(no history of bilateral tubal ligation, hysterectomy, or bilateral
salpingo-oophorectomy), and are not postmenopausal for at least 1 year.
Furthermore, male study patients must also not donate sperm from Day
1/Baseline (Visit 5) until 90 days after the last dose of investigational
product. In the German territory, women of childbearing potential are
not eligible to enter the study.
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. A positive pregnancy test or breast-feeding for female patients.
2. History of type 1 diabetes.
3. Any other non-diabetic kidney disease(s) except for hypertensive
nephropathy which is acceptable.
4. Diagnostic or interventional procedure requiring a contrast agent
within 4 weeks of the first screening visit (Visit 1) or planned during the
study.
5. History of renal transplant or planned renal transplant during the
study.
6. A history of acute renal dialysis or acute kidney injury (defined
according to the Kidney Disease: Improving Global Outcomes [KDIGO]
definition) within 12 weeks of the first screening visit (Visit 1)
7. A body mass index (BMI) <18.5 kg/m2.
8. Elevated liver enzymes (alkaline phosphatase or alanine
aminotransferase [ALT]) >3 x the upper limit of normal (ULN), or
bilirubin >1.5 x the ULN) during the screening period (to enter the run-in
period) and during the run-in period (to enter the double-blind
treatment period).
9. HA1c level >11% (97 mmol/mol).
10. Inadequately controlled arterial blood pressure, defined as:
a) SBP >180 mmHg and <110 mmHg at the screening visits to be eligible
to enter the run-in period, determined as described in Section 9.1.1.
b) SBP >160 mmHg and <110 mmHg at Visit 5 to enter the double-blind
treatment period, determined as described in Section 9.1.1.
11. History of hypothyroidism requiring hormone replacement therapy
unless the dose of thyroid hormone(s) has been stable at least 4 weeks
prior to the Visit 1 and the TSH value is not greater then upper limit of
the normal range at Visit 1.
12. History of active cardiovascular disease defined as the occurrence of
the following events or conditions within the 12 weeks preceding the
first screening visit (Visit 1): acute myocardial infarction; unstable
angina pectoris; stroke, including a transient ischemic attack; a coronary
revascularization procedure; congestive heart failure New York Health
Association (NYHA) Class III or IV.
13. A personal or family history of long QT syndrome.
14. Evidence of any of the following cardiac conduction abnormalities
during the screening period (to enter the run-in period) and during the
run-in period (to enter the double-blind treatment period):
- A QTc Fredericia interval >450 milliseconds for males and >470
milliseconds for females.
- A second or third degree atrioventricular block not successfully treated
with a pacemaker.
15. History of cancer in the preceding 5 years, except adequately treated
non-melanoma skin cancer, carcinoma in situ of the cervix, in situ
prostate cancer, in situ breast ductal carcinoma, or superficial bladder
cancer (stage 0).
16. Current history of drug or alcohol abuse, as assessed by the
Investigator.
17. The occurrence of any acute infection requiring systemic antibiotic
therapy within the 2 weeks prior to the first day of the run-in period,
Week -4 (Visit 3), or infection with hepatitis B, hepatitis C, or human
immunodeficiency virus (HIV) infection.
18. A history of bone marrow disorder including aplastic anemia, or
marked anemia defined as hemoglobin <10.0 g/dL (or 6.2 mmol/L)
during screening.
19. Administration of any investigational product within 30 days or
within 5 half-lives of the investigational agent (whichever is longer) of
the first day of the run-in period, Week -4 (Visit 3).
20. Any condition which, in the opinion of the Investigator, constitute a
risk or contraindication for the participation of the p

Study & Design

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