Overview

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

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Targacept Inc.
Criteria
Inclusion Criteria:

- Males or postmenopausal/surgically sterile females

- Being treated for T2DM with oral antidiabetic agents (excluding glitazones)

- BMI limit ≤ 38

- Subjects at least 80% compliant on reporting daily SMBG values during washout

- At the end of washout the subject's fasting SMBG is higher than it was at the start of
washout and the fasting SMBG ≤ 280.g treated for T2DM with oral antidiabetic agents
(excluding glitazones)

Exclusion Criteria:

- Type 1 diabetes mellitus

- Severe complications of T2DM (especially diabetic retinopathy imminently requiring
treatment for preserving or restoring vision, diabetic neuropathy with symptomatic
orthostatic hypotension, urinary retention, gastric stasis, or pedal ulcers)

- Current treatment with insulin or a glitazone

- Use of moderate to strong cytochrome P450 3A4 (CYP3A4) inhibitors

- FSH level of < 35 IU/L and a LH level < 25 IU/L except for confirmed surgically
sterile women with functioning ovaries

- Significant cardiovascular diseases (including arrhythmia) or congestive heart
failure, or severe ischemic disease within the last 3 months prior to Screening, or
evidence of stroke, myocardial infarction, unstable angina, coronary bypass and/or
percutaneous transluminal coronary angioplasty

- History of significant other major or unstable neurological, metabolic, hepatic,
renal, hematological, pulmonary, CV, GI, or urological disorder; or diagnosis of major
depressive disorder; if stable medical disorder, any medical treatment must be stable
for last 2 months prior to Screening

- History of diabetic ketoacidosis

- Patients who have an increased red blood cell (RBC) turn-over or thalassemia or anemia

- Known HIV or history of viral hepatitis type B or C

- Systemic infection with TB

- Current or previous use of oral or injectable corticosteroids 3 months prior to
screening.

- Subject has persistent, uncontrolled severe hypertension as indicated by a systolic
blood pressure > 180 mmHg or a diastolic blood pressure of > 110 mmHg, with or without
treatment

- Subject has had a malignancy in the last 5 years, except for successfully treated
basal or squamous cell carcinoma of the skin or of the cervix

- Subject is receiving chemotherapy

- Tobacco user within 4 months prior to Screening

- Smoking cessation therapy within 4 months prior to Screening and/or planned during the
study

- Use of prohibited concomitant medications including psychoactive agents

- History within 6 months prior to Screening of alcohol abuse or illicit drug abuse

- Was administered study medication in another clinical trial in the past 3 months prior
to Screening