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NCT02647320 · ClinicalTrials.gov registry record · Phase 2
12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
A Phase 2 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 298
- Enrollment target
NCT02647320: Completed Phase 2 study, sponsored by Daiichi Sankyo.
NCT02647320 is a Phase 2 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 298 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (124% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02647320, a Phase 2 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 298 participants
- Enrollment target
Study Summary
The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.
Primary Outcome
Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.
Interventions
- DRUG Placebo Tablet
- DRUG Placebo Capsule
- DRUG Sitagliptin 100 mg
- DRUG DS-8500a 25mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2016-01 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 2 |
What the finished NCT02647320 record still lists
NCT02647320 is an interventional study that assigns participants to a tested intervention. The registered 298 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 (124% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo Tablet is the first listed.
NCT02647320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02647320 about?
NCT02647320 is a clinical study titled "12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin". The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.
What is the current status of trial NCT02647320?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 298 participants. The study started on 2016-01. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02647320?
The interventions under investigation include: Placebo Tablet (DRUG), Placebo Capsule (DRUG), Sitagliptin 100 mg (DRUG), DS-8500a 25mg (DRUG).
Who is sponsoring clinical trial NCT02647320?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02647320's enrollment target sits among peer trials
298 188th of 2000 higher than 1,813 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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