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

NCT ID: NCT01264497

Last Updated: 2010-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2002-11-30

Brief 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

TH9507

1 and 2 mg, sc daily for 12 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theratechnologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Theratechnologies

References

Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One. 2017 Jun 15;12(6):e0179538. doi: 10.1371/journal.pone.0179538. eCollection 2017.

Reference Type: DERIVED

PMID: 28617838 (View on PubMed)

Other Identifiers

TH9507/II/Diabetes/006

Identifier Type: -

Identifier Source: org_study_id