Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes

Inclusion criteria

• Male or postmenopausal or surgically sterilized female subjects, 50 years of age or older;
• Documented diagnosis of type 2 diabetes as defined by the American Diabetes Association;
• Diagnosis of type 2 diabetes for at least 3 months before screening;
• Subjects on stable diabetes treatment regimens (receiving oral hypoglycemics with or without insulin) for at least 2 months before screening;
• Screening and pre-randomization glycosylated hemoglobin (HbA1c) <10.0%, according to central laboratory;
• Body mass index (BMI) between 25 and 38 kg/m2
• Subjects willing to perform specified home blood glucose monitoring and comply with all study protocol requirements;
• Signed informed consent.

Exclusion criteria

• Serum creatinine >2 mg/dL;
• Fasting triglycerides >1000 mg/dL;
• Albuminuria >200 mg/24 hours;
• Positive mammography (if female) or prostate-specific antigen (PSA) or prostate examination for cancer (if male);
• Use of oral or parenteral glucocorticoids in the 30 days before screening;
• Use of any experimental or marketed growth hormone, growth hormone secretagogues, insulin-like growth factor-1 (IGF-1), or insulin-like growth factor binding protein-3 (IGFBP-3) during the previous 6 months;
• Subjects with two or more severe hypoglycemia episodes within the past 6 months, or any hospitalization or emergency room visit due to poor glycemic control within the past 6 months. Similarly, during the lead-in period, any subject with more than one severe hypoglycemic episode or any hospitalization or emergency room visit due to poor glycemic control will be excluded from randomization;
• History of or presence of active concomitant conditions or diseases (e.g., myocardial infarction, poorly controlled hypertension, thyroid disease, rheumatoid arthritis, seizure disorder, diabetic neuropathy, diabetic retinopathy [except subjects with only microaneurysms on fundus examination]) that would interfere with the protocol conduct and endpoint measurements;
• Subjects with a major surgical operation during the 30 days before screening;
• Subjects with known hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma;
• Current cancer or history of cancer, except non-melanomatous skin cancer;
• Subjects with active infection at any body site or a history of severe infection (requiring oral or parenteral treatment) during the 30 days before screening;
• Subjects with clinically significant abnormalities on screening laboratory evaluation (unless discussed with and approved by the medical monitor);
• Subjects with allergy to synthetic growth hormone products or their excipients;
• Subjects who had previously received growth hormones in any clinical trial;
• Participation in a trial of an experimental drug or device within 90 days before screening.