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

Highland Clinical Research

Salt Lake City, Utah 84124

775

from

Salt Lake City, UT