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
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 April 16, 2014