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NCT01809327 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,186
- Enrollment target
- 20
- Study locations
NCT01809327: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development.
NCT01809327 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Janssen Research & Development. The registered enrollment target is 1,186 participants, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01809327, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,186 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.
Primary Outcome
The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.
Conditions Studied
Interventions
- DRUG Metformin XR
- DRUG Canagliflozin 100 mg
- DRUG Canagliflozin 300 mg
Study Locations (20)
California
- - Encinitas
- - Newport Beach
- - Northridge
- - Norwalk
- - Rancho Cucamonga
- - Walnut Creek
Florida
- - Hialeah
- - Miami
- - New Port Richey
- - Opa-locka
Louisiana
- - Mandeville
- - Metairie
- - Sunset
Colorado
- - Denver
- - Northglenn
Alabama
- - Birmingham
Arizona
- - Phoenix
Georgia
- - Perry
Indiana
- - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,186 participants |
| Start Date | 2013-06-04 |
| Est. Completion | 2014-12-02 |
| Phase | Phase 3 |
What the finished NCT01809327 record still lists
NCT01809327 is an interventional study that assigns participants to a tested intervention. Its 1,186 participants enrollment target places it among the larger protocols in the corpus, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 3 interventions - of which Metformin XR is the first listed.
NCT01809327 names 20 study sites across 9 states, led by California, Florida, Louisiana.
Frequently Asked Questions
What is clinical trial NCT01809327 about?
NCT01809327 is a clinical study titled "A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise". The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise....
What is the current status of trial NCT01809327?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,186 participants. The study started on 2013-06-04. Estimated completion is 2014-12-02.
What conditions does trial NCT01809327 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT01809327?
The interventions under investigation include: Metformin XR (DRUG), Canagliflozin 100 mg (DRUG), Canagliflozin 300 mg (DRUG).
Who is sponsoring clinical trial NCT01809327?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01809327 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, 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 NCT01809327's enrollment target sits among peer trials
1,186 28th of 348 higher than 321 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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