Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Genkyotex Innovation SAS
Sponsor:
Information provided by (Responsible Party):
Genkyotex Innovation SAS
ClinicalTrials.gov Identifier:
NCT02010242
First received: June 18, 2013
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor.

The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.


Condition Intervention Phase
Type 2 Diabetes Mellitus With Diabetic Nephropathy
Drug: GKT137831
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients With Type 2 Diabetes and Albuminuria

Resource links provided by NLM:


Further study details as provided by Genkyotex Innovation SAS:

Primary Outcome Measures:
  • Albuminuria [ Time Frame: Visits 4 (week -2), 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12), and 12 (week 16) ] [ Designated as safety issue: No ]
    Change in UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively)


Secondary Outcome Measures:
  • Glucose metabolism [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ] [ Designated as safety issue: No ]
    Change in HOMA-B, HOMA-IR and HbA1c from baseline


Other Outcome Measures:
  • Erectile dysfunction [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ] [ Designated as safety issue: No ]
    Changes in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline

  • Neuropathic pain [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ] [ Designated as safety issue: No ]
    Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GKT137831
GKT137831 100 mg capsules twice a day
Drug: GKT137831
1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
Placebo Comparator: Placebo
Placebo capsule twice a day
Drug: Placebo
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.

Detailed Description:

A double-blind, placebo-controlled, randomized, multicenter, parallel group Phase 2 study assessing a 12-week period of treatment with oral GKT137831 administered in addition to standard of care for patients with type 2 diabetes.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female aged 18 to 80 years
  • History of type 2 diabetes, defined as fasting plasma glucose ≥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.
  • Albuminuria defined as a UACR of 300 to 3500 mg/g.
  • An eGFR ≥30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.
  • 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.

Key Exclusion Criteria:

  • History of type 1 diabetes
  • Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable.
  • Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (Visit 1) or planned during the study.
  • History of renal transplant or planned renal transplant during the study.
  • 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)
  • HbA1c level >11% (97 mmol/mol).
  • History of hypothyroidism requiring hormone replacement therapy.
  • History of active cardiovascular disease
  • A personal or family history of long QT syndrome.
  • Administration of any investigational product within 30 days or within 5 half-lives of the investigational agent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010242

Contacts
Contact: Philippe Wiesel, MD +33.6.73.63.67.21 philippe.wiesel@genkyotex.com
Contact: Jacques Herve, MSc +33.4.56.44.81.12 jacques.herve@genkyotex.com

  Show 58 Study Locations
Sponsors and Collaborators
Genkyotex Innovation SAS
  More Information

No publications provided

Responsible Party: Genkyotex Innovation SAS
ClinicalTrials.gov Identifier: NCT02010242     History of Changes
Other Study ID Numbers: GSN000200
Study First Received: June 18, 2013
Last Updated: July 1, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Poland: The Central Register of Clinical Trials
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Genkyotex Innovation SAS:
Type 2 diabetes
Proteinuria
Albuminuria

Additional relevant MeSH terms:
Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on August 21, 2014