Clinical trial NCT01293669 (phase 2, status: completed)
Conditions: type 2 diabetes mellitus
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: tc-6987, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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