NCT01264497CompletedPhase 2
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Theratechnologies
- Enrollment
- 55
- Primary Endpoint
- Change from baseline in relative insulin response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change from baseline in relative insulin response
Secondary Outcomes
- Change from baseline in glycosylated hemoglobin (HbA1c)
- Change in mean daily serum glucose concentrations
- 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
Investigators
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