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NCT01081834 · ClinicalTrials.gov registry record · Phase 3
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 678
- Enrollment target
NCT01081834: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01081834 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 678 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081834, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 678 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
Primary Outcome
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 26 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.
Interventions
- DRUG Placebo
- DRUG Sitagliptin
- DRUG Canagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 678 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT01081834 record still lists
NCT01081834 is an interventional study that assigns participants to a tested intervention. The registered 678 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01081834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01081834 about?
NCT01081834 is a clinical study titled "The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial". The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.
What is the current status of trial NCT01081834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 678 participants. The study started on 2010-03. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01081834?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG), Canagliflozin (DRUG).
Who is sponsoring clinical trial NCT01081834?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01081834's enrollment target sits among peer trials
678 536th of 2000 higher than 1,464 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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