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

• Status: Completed
• Trial end date: 2002-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine whether TH9507, a stabilized analogue of growth hormone-releasing factor (GRF), would have an effect on insulin sensitivity or control of diabetes in patients with type 2 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theratechnologies
• Treatments: Tesamorelin

Criteria

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.