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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Type 2 Diabetes

Intervention / Treatment
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* Drug: TH9507


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TH9507|1 and 2 mg, sc daily for 12 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in relative insulin response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |