Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
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|ClinicalTrials.gov Identifier: NCT02010242|
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : March 30, 2015
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 or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus With Diabetic Nephropathy||Drug: GKT137831 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||March 2015|
GKT137831 100 mg capsules twice a day
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
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
- 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) ]Change in UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively)
- Glucose metabolism [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ]Change in HOMA-B, HOMA-IR and HbA1c from baseline
- Erectile dysfunction [ Time Frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12) ]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) ]Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010242
|Study Director:||Philippe Wiesel, MD||Genkyotex Innovation SAS|