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NCT01340664 · ClinicalTrials.gov registry record · Phase 2
An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 279
- Enrollment target
NCT01340664: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT01340664 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 279 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (110% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01340664, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 279 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) control.
Primary Outcome
The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 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 Metformin
- DRUG Canagliflozin 50 mg
- DRUG Canagliflozin 150 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 279 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01340664 record still lists
NCT01340664 is an interventional study that assigns participants to a tested intervention. The registered 279 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (110% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01340664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01340664 about?
NCT01340664 is a clinical study titled "An Efficacy, Safety, and Tolerability Study of Canagliflozin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Monotherapy". The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (ie, treatment with a single drug) and have inadequate glycemic (blood sugar) ...
What is the current status of trial NCT01340664?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 279 participants. The study started on 2011-07. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01340664?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG), Canagliflozin 50 mg (DRUG), Canagliflozin 150 mg (DRUG).
Who is sponsoring clinical trial NCT01340664?
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 NCT01340664's enrollment target sits among peer trials
279 201st of 2000 higher than 1,799 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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