Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus

Status:	Archived
Conditions:	Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	January 2011
End Date:	December 2011

Phase II Study of Glycemic Control, Safety, Tolerability and Pharmacokinetic Parameters of TC-6987 Monotherapy in Subjects With Type 2 Diabetes Mellitus

TC-6987 is a selective nicotinic Î±-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-Î±
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.

We found this trial at

sites

Medical Frontiers

Carlisle, Ohio 45005

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Carlisle, OH