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Trial · Interventional

CompletedPhase 2Registry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
55 participants (actual)
Sponsor
Theratechnologies · Industry
Design
Randomized · Double masking
Countries
Not stated
Start
Feb 2002
Primary completion
Nov 2002
Completion
Nov 2002
First posted
21 Dec 2010 (estimated)
Last update posted
21 Dec 2010 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003
  1. Ph 2

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

    NCT01264497

    Feb 2002 to Nov 2002

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TH9507Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from baseline in relative insulin response

Secondary outcomes(4)
  1. Change from baseline in glycosylated hemoglobin (HbA1c)

  2. Change in mean daily serum glucose concentrations

    Registry description

    Home blood glucose will be obtained four times per day (before breakfast, lunch, and dinner, and at bedtime) using a standard blood glucose meter

  3. Changes in the number of dose adjustments per week for insulin and/or oral hypoglycemic agents

  4. Number of subjects with a change in the control of diabetes

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

8 results

Safety and metabolic effects of tesamorelin, a growth hormone-releasing factor analogue, in patients with type 2 diabetes: A randomized, placebo-controlled trial.

Clemmons et al. 2017PloS onecited by 15

PMID 28617838PMC5472315DOI 10.1371/journal.pone.0179538PUB-28617838

CC BY8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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