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NCT02010242 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
A Phase 2 study of Type 2 Diabetes Mellitus With Diabetic Nephropathy, sponsored by Calliditas Therapeutics AB.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
- 20
- Study locations
NCT02010242: Completed Phase 2 study of Type 2 Diabetes Mellitus With Diabetic Nephropathy, sponsored by Calliditas Therapeutics AB.
NCT02010242 is a Phase 2 study of Type 2 Diabetes Mellitus With Diabetic Nephropathy that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02010242, a Phase 2 study of Type 2 Diabetes Mellitus With Diabetic Nephropathy, has completed, sponsored by Calliditas Therapeutics AB.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively). Baseline for UACR is defined as the geometric mean of the geometric means of the UACR values measured on Day-14 (visit 4) and Day 1 (visit 5). End of treatment is defined as the geometric mean of the geometric means of the UACR values measured at week 8 (visit 9), week 10 (visit 10) and week 12 (visit 11).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GKT137831
Study Locations (20)
Florida
- Clinical Research of South Florida - Coral Gables
- The Center for Diabetes and Endocrine Care - Hollywood
- Jacksonville Center for Clinical Research - Jacksonville
- Genoma Research Group, Inc. - Miami
- Coral Research Clinic - Miami
- Pines Clinical Research Inc. - Pembroke Pines
- Volunteer Medical Research - Port Charlotte
Texas
- The University of Texas Southwestern Medical Center - Dallas
- 17070 Red Oak dr Ste 103 - Houston
- Dialysis West University Health System - San Antonio
Arizona
- Advanced Arizona Clinical Research - Tucson
California
- The Endocrine Medical Group, Inc - Orange
Illinois
- John H. Stroger Jr. Hospital of Cook County - Chicago
Indiana
- Community Medical Research Partners - Indianapolis
Missouri
- Kansas City VA Medical Center - Kansas City
Nebraska
- Creighton Diabetes Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT02010242 record still lists
NCT02010242 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 1 condition, with Type 2 Diabetes Mellitus With Diabetic Nephropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02010242 names 20 study sites across 12 states, led by Florida, Texas, Arizona.
Frequently Asked Questions
What is clinical trial NCT02010242 about?
NCT02010242 is a clinical study titled "Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria". 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 albumin...
What is the current status of trial NCT02010242?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2013-10. Estimated completion is 2015-03.
What conditions does trial NCT02010242 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy.
What interventions are being tested in trial NCT02010242?
The interventions under investigation include: Placebo (DRUG), GKT137831 (DRUG).
Who is sponsoring clinical trial NCT02010242?
This trial is sponsored by Calliditas Therapeutics AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02010242 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02010242's enrollment target sits among peer trials
136 527th of 2000 higher than 1,469 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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