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NCT01555164 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 442
- Enrollment target
NCT01555164: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01555164 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 442 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555164, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 442 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.
Primary Outcome
The average (mean) change from baseline in HbA1c at Week 24 was analyzed.
Interventions
- DRUG Metformin
- BEHAVIORAL Diet
- DRUG Ranolazine
- DRUG Placebo to match ranolazine
- DRUG Placebo to match metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
What the finished NCT01555164 record still lists
NCT01555164 is an interventional study that assigns participants to a tested intervention. The registered 442 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 (43% lower).
The record links to 0 conditions, and to 5 interventions - of which Metformin is the first listed.
NCT01555164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01555164 about?
NCT01555164 is a clinical study titled "A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone". This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin t...
What is the current status of trial NCT01555164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 442 participants. The study started on 2012-06. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01555164?
The interventions under investigation include: Metformin (DRUG), Diet (BEHAVIORAL), Ranolazine (DRUG), Placebo to match ranolazine (DRUG), Placebo to match metformin (DRUG).
Who is sponsoring clinical trial NCT01555164?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01555164's enrollment target sits among peer trials
442 867th of 2000 higher than 1,134 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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