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

This study has been completed.
Sponsor:
Information provided by:
Theratechnologies
ClinicalTrials.gov Identifier:
NCT01264497
First received: December 17, 2010
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: TH9507
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Theratechnologies:

Primary Outcome Measures:
  • Change from baseline in relative insulin response [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in glycosylated hemoglobin (HbA1c) [ Designated as safety issue: Yes ]
  • Change in mean daily serum glucose concentrations [ Designated as safety issue: Yes ]
    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 [ Designated as safety issue: Yes ]
  • Number of subjects with a change in the control of diabetes [ Designated as safety issue: Yes ]

Enrollment: 55
Study Start Date: February 2002
Study Completion Date: November 2002
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: TH9507
    1 and 2 mg, sc daily for 12 weeks
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Bruno Lussier/Medical Director, Theratechnologies
ClinicalTrials.gov Identifier: NCT01264497     History of Changes
Other Study ID Numbers: TH9507/II/Diabetes/006
Study First Received: December 17, 2010
Last Updated: December 20, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014