A Phase 2 interventional study of TC-6987 and Placebo in Type 2 Diabetes Mellitus, sponsored by Targacept Inc.. Completed at 18 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-13.
Sponsored by Targacept Inc. · Phase 2, Interventional, and Treatment
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.
This is a Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy, safety, tolerability, and pharmacokinetic parameters of TC-6987 in subjects with type 2 diabetes mellitus (T2DM). The study is organized into three phases: (a) Screening phase consisting of a 1-week Screening (Week -5)and a 4-week Washout (Week -4 to Day 1); (b) 4-week, Double-Blind Treatment (Day 1 to Week 4) during which subjects are randomized to either TC-6987 (20 mg on Day 1 and 10 mg from Day 2 to Week 4) or placebo; and (c) 2-week Follow-Up (Week 6). Unscheduled visits will be allowed between visits from Washout through Follow-up to evaluate a subject's glycemic status or other safety issues, as required. Subjects will fast overnight for a minimum of 10 hrs and refrain from drinking alcohol 24 hrs prior to each visit.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 440 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Targacept Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: TC-6987
Drug: Placebo
TC-6987-23 (TC-6987 HCl) as experimental treatment: 20 mg loading dose (2 capsules) on Day 1 and 10 mg (1 capsule) on Days 2 to 28 (dose expressed as free base). Each dose will be given once daily.
Matching placebo: Mode of administration: p.o. (microcrystalline cellulose in capsule) given once daily.
Changes in fasting plasma glucose (FPG)
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.
Time frame: Day 1 and Week 4
Change in FPG from Day 1 (Baseline) at each time point
Change in FPG from Day 1 (Baseline) compared to weeks 1 and 4
Time frame: Day 1, Week 1 and Week 4
Change in FPG and insulin from Day 1 (Baseline) at each time point
Change in FPG and insulin from Day 1 (Baseline) compared to weeks 1 and 4
Time frame: Day 1, Week 1 and Week 4
Change in AUC FPG from Day 1 (Baseline) and at Week 4
Change in AUC FPG from Day 1 (Baseline) compared to weeks 1 and 4
Time frame: Day 1 and Week 4
Change in AUC insulin from Day 1 (Baseline) at Week 4
Change in AUC insulin from Day 1 (Baseline) compared to week 4
Time frame: Day 1 and Week 4
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Targacept Inc.