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NCT02597400 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction Study of Glucokinase Activator HMS5552 and Metformin in T2DM
A Phase 1 study, sponsored by Hua Medicine Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02597400: Completed Phase 1 study, sponsored by Hua Medicine Limited.
NCT02597400 is a Phase 1 study that has completed, run by Hua Medicine Limited. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02597400, a Phase 1 study, has completed, sponsored by Hua Medicine Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).
Primary Outcome
HMS5552 and metformin PK parameters: PK parameters (Cmax) will be computed for each subject per day with non-compartmental methods using the actual sampling times. Descriptive statistics will be calculated for the PK parameters per day (Days 3, 8 and 13). The effect of metformin on the exposure of HMS5552 will be determined by a PK comparison between the exposure of HMS5552 on Day 13 vs. on Day 8. The effect of HMS5552 on the exposure of metformin will be determined by a PK comparison between t
Interventions
- DRUG Metformin
- DRUG HMS5552
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-10 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
What the finished NCT02597400 record still lists
NCT02597400 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Metformin is the first listed.
NCT02597400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02597400 about?
NCT02597400 is a clinical study titled "Drug-Drug Interaction Study of Glucokinase Activator HMS5552 and Metformin in T2DM". This is a Phase 1, open-label, sequential, multiple-dose, drug-drug interaction study of GK activator HMS5552 and metformin in patients with type 2 diabetes mellitus (T2DM).
What is the current status of trial NCT02597400?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-10. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02597400?
The interventions under investigation include: Metformin (DRUG), HMS5552 (DRUG).
Who is sponsoring clinical trial NCT02597400?
This trial is sponsored by Hua Medicine Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02597400's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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