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

A Double-blind, Randomized, Parallel, Placebo-controlled 12-week Evaluation of the Safety of Two Doses of TH9507 in Subjects With Stable, Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: TH9507

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in relative insulin response

Secondary Outcome Measures

Outcome Measure	Measure Description
Change from baseline in glycosylated hemoglobin (HbA1c)
Change in mean daily serum glucose concentrations	Home blood glucose will be obtained four times per day (before breakfast, lunch, and dinner, and at bedtime) using a standard blood glucose meter
Changes in the number of dose adjustments per week for insulin and/or oral hypoglycemic agents
Number of subjects with a change in the control of diabetes

Collaborators and Investigators

• Sponsor: Theratechnologies

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion (Actual): November 1, 2002
• Study Completion (Actual): November 1, 2002

Study Registration Dates

• First Submitted: December 17, 2010
• First Submitted That Met QC Criteria: December 20, 2010
• First Posted (Estimate): December 21, 2010

Study Record Updates

• Last Update Posted (Estimate): December 21, 2010
• Last Update Submitted That Met QC Criteria: December 20, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Growth Substances; Tesamorelin
• Other Study ID Numbers: TH9507/II/Diabetes/006