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NCT01154348 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus
A Phase 1 study of Type 2 Diabetes Mellitus, sponsored by Shionogi.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT01154348: Completed Phase 1 study of Type 2 Diabetes Mellitus, sponsored by Shionogi.
NCT01154348 is a Phase 1 study of Type 2 Diabetes Mellitus that has completed, run by Shionogi. The registered enrollment target is 34 participants, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01154348, a Phase 1 study of Type 2 Diabetes Mellitus, has completed, sponsored by Shionogi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus
Primary Outcome
Safety will be evaluated by monitoring of treatment-emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiograms, 24-hour telemetry monitoring and physical exams. Pharmacokinetic evaluation of monotherapy cohort versus add-on therapy will be done
Conditions Studied
Interventions
- DRUG Placebo
- DRUG S-707106
- DRUG Metformin, S-707106 plus metformin
- DRUG Metformin, placebo plus metformin
Study Locations (1)
Texas
- Dennis Ruff, MD - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
What the finished NCT01154348 record still lists
NCT01154348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 2,960-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01154348 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01154348 about?
NCT01154348 is a clinical study titled "Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus". The purpose of this study is to determine the safety and pharmacokinetics of double-blind S-707106 alone and in combination with open-label metformin in patients with type 2 diabetes mellitus
What is the current status of trial NCT01154348?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-06. Estimated completion is 2010-12.
What conditions does trial NCT01154348 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus.
What interventions are being tested in trial NCT01154348?
The interventions under investigation include: Placebo (DRUG), S-707106 (DRUG), Metformin, S-707106 plus metformin (DRUG), Metformin, placebo plus metformin (DRUG).
Who is sponsoring clinical trial NCT01154348?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01154348 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01154348's enrollment target sits among peer trials
34 89th of 130 higher than 42 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus 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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