Type 2 Diabetes
Conditions
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.
Interventions
DRUGTH9507
1 and 2 mg, sc daily for 12 weeks
Sponsors
Theratechnologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in relative insulin response | — |
Secondary
| Measure | Time frame | 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 | — | — |
Outcome results
None listed