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NCT01293669 · ClinicalTrials.gov registry record · Phase 2
Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus
A Phase 2 study, sponsored by Targacept.
- Completed
- Registry status
- Phase 2
- Development phase
- 440
- Enrollment target
NCT01293669: Completed Phase 2 study, sponsored by Targacept.
NCT01293669 is a Phase 2 study that has completed, run by Targacept. The registered enrollment target is 440 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (231% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01293669, a Phase 2 study, has completed, sponsored by Targacept.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 440 participants
- Enrollment target
Study Summary
TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks, numerous metabolic improvements were observed. Specifically, plasma glucose and triglyceride concentrations declined by approximately 30%; Hb1Ac was reduced by nearly 50%; and TNF-α declined more than 60% relative to control db/db mice Therefore, it appears that TC-6987 could prove beneficial in reducing elevated glucose concentrations in diabetic patients as well as in ameliorating organ damage associated with inflammation, oxidative stress and hyperglycemia.
Primary Outcome
The primary efficacy endpoint will be FPG values obtained at Week 4 compared to Day 1 (baseline). This change from baseline will be analyzed using MMRM techniques with an alpha of 0.10 (one-sided), to examine differences between the TC-6987 and placebo treatment cohorts. This change from baseline will be analyzed using the primary efficacy endpoints for the mITT analysis set. The efficacy analyses based on the Per Protocol (PP) analysis set will be considered secondary.
Interventions
- DRUG Placebo
- DRUG TC-6987
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT01293669 record still lists
NCT01293669 is an interventional study that assigns participants to a tested intervention. The registered 440 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 (231% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01293669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01293669 about?
NCT01293669 is a clinical study titled "Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus". TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks, numerous metabolic improvem...
What is the current status of trial NCT01293669?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 440 participants. The study started on 2011-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01293669?
The interventions under investigation include: Placebo (DRUG), TC-6987 (DRUG).
Who is sponsoring clinical trial NCT01293669?
This trial is sponsored by Targacept, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01293669's enrollment target sits among peer trials
440 89th of 2000 higher than 1,912 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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