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NCT03170518 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 171
- Enrollment target
- 20
- Study locations
NCT03170518: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development.
NCT03170518 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Janssen Research & Development. The registered enrollment target is 171 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03170518, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 171 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.
Primary Outcome
Change from baseline in HbA1c at Week 26 was analyzed using a pattern mixture model with multiple imputation. Data for this outcome measure was planned to be collected and analyzed for the combined population of arm Canagliflozin 100 mg and Canagliflozin 300 mg.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Canagliflozin 100 mg
- DRUG Canagliflozin 300 mg
Study Locations (20)
Florida
- TOPAZ Clinical Research - Apopka
- Columbus Clinical Services LLC - Miami
- Medical Research Center of Miami II Inc - Miami
- Nicklaus Children's Hospital - Miami
- Nemours Children's Hospital/Endocrinology - Orlando
- Asclepes Research - Spring Hill
- Johns Hopkins All Children's Hospital - St. Petersburg
California
- Center of Excellence for Diabetes and Endocrinology (CEDE) - Sacramento
- American Institute of Research - Whittier
Georgia
- Appalachian Clinical Research - Adairsville
- Endocrine Consultants Research - Columbus
Arkansas
- Arkansas Childrens Hospital - Little Rock
Colorado
- University of Colorado School of Medicine/Children's Hospital Colorado - Aurora
Delaware
- Nemours DuPont Hospital for Children - Wilmington
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Maryland
- Capital Diabetes and Endocrine Associates - Camp Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2017-07-21 |
| Est. Completion | 2023-09-20 |
| Phase | Phase 3 |
What the finished NCT03170518 record still lists
NCT03170518 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03170518 names 20 study sites across 12 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT03170518 about?
NCT03170518 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus". The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.
What is the current status of trial NCT03170518?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 171 participants. The study started on 2017-07-21. Estimated completion is 2023-09-20.
What conditions does trial NCT03170518 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT03170518?
The interventions under investigation include: Placebo (DRUG), Canagliflozin 100 mg (DRUG), Canagliflozin 300 mg (DRUG).
Who is sponsoring clinical trial NCT03170518?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03170518 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03170518's enrollment target sits among peer trials
171 164th of 348 higher than 185 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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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