Safety and Efficacy of BGP-15 in Patients With Type 2 Diabetes Mellitus

Inclusion Criteria

• •Patients meeting all of the following criteria will be eligible for enrollment:
• •1. Male and female patients with T2DM at time of diagnosis as defined by the American Diabetes Association (ADA) criteria;
• •2. Age between 30 and 70 years (inclusive);
• •3. HbA1c ≥7.5% - ≤12.0% at Screening, Visit 1;
• •4. FPG ≤270 mg/dL (15.0 mmol/L);
• •5. Body mass index (BMI) \>27 and ≤40 kg/m2;
• •6. Current treatment with either metformin alone or in combination with SU. The dose of the current treatment must be stable for at least 8 weeks prior to randomization. Patients being treated with metformin must be at their optimal or near-optimal dose (≥1500 mg/day ± 500 mg/day for a range of 1000 to 2000 mg/day), and patients being treated with SU must be receiving at least one half of the maximum approved SU dose;
• •7. Women may be enrolled if all three of the following criteria are met:
• •1. They have a negative serum pregnancy test at Screening;
• •2. They are not breast feeding; and,
• •3. They do not plan to become pregnant during the study AND if one of the following three criteria is met:
• •i. They have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form; ii. They have been postmenopausal for at least 1 year; or, iii. They are of childbearing potential and will practice one of the following methods of birth control throughout the study: injectable or implantable hormonal contraception or intrauterine device; or two of the following methods of birth control throughout the study: oral or patch contraception plus a barrier contraceptive (eg, diaphragm plus spermicide, male or female condom plus spermicide, or vasectomized male partner). Abstinence, partner's use of condoms, and vasectomy are NOT acceptable methods of contraception;
• •8. Willingness to sign an informed consent document; and,
• •9. No conditions that hinder participation in the trial, as determined by the Investigator and Sponsor.