Status:
COMPLETED
Safety Study of TH9507 in Subjects With Stable, Type 2 Diabetes
Lead Sponsor:
Theratechnologies
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2002
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01264497
Start Date
February 1 2002
End Date
November 1 2002
Last Update
December 21 2010
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