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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01809327
The ClinicalTrials.gov registry entry for NCT01809327 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,186 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,482-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (74% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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