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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264497
• Other study ID #: TH9507/II/Diabetes/006
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2010
• Last updated: December 20, 2010
• Start date: February 2002
• Est. completion date: November 2002

Study information

• Verified date: December 2010
• Source: Theratechnologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• TH9507
1 and 2 mg, sc daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Theratechnologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in relative insulin response			Yes
Secondary	Change from baseline in glycosylated hemoglobin (HbA1c)			Yes
Secondary	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		Yes
Secondary	Changes in the number of dose adjustments per week for insulin and/or oral hypoglycemic agents			Yes
Secondary	Number of subjects with a change in the control of diabetes			Yes