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

NCT01264497 | Completed Phase 2

• 1 other identifier: TH9507/II/Diabetes/006
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in relative insulin response

Secondary Outcomes (4)

• 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

Interventions

TH9507 DRUG

1 and 2 mg, sc daily for 12 weeks

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Theratechnologies: lead

Related Publications (1)

• Clemmons DR, Miller S, Mamputu JC. Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial. PLoS One. 2017 Jun 15;12(6):e0179538. doi: 10.1371/journal.pone.0179538. eCollection 2017.

  PMID: 28617838 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 21, 2010
• Study Start: February 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: December 21, 2010

Record last verified: 2010-12