Clinical trial NCT01264497: Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Theratechnologies
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in relative insulin response
Secondary outcomes:
measure: Change from baseline in glycosylated hemoglobin (HbA1c)
measure: Change in mean daily serum glucose concentrations
measure: Changes in the number of dose adjustments per week for insulin and/or oral hypoglycemic agents
measure: Number of subjects with a change in the control of diabetes
Other outcomes:
Locations:
Study officials:
References:
citation: 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.