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

What Was Tested

This registered phase 2 trial tested Tesamorelin.

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.

The registry classes the interventions as drug.

Who Took Part

The registry lists 55 actual participants took part.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;. Body mass index (BMI) between 25 and 38 kg/m2.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: 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;; subjects with a major surgical operation during the 30 days before screening;.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Tesamorelin group and the comparison group should start out alike.

The Tesamorelin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tesamorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2002-02 with completion listed for 2002-11.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline in relative insulin response.

It also tracked 4 secondary outcomes, for example Change from baseline in glycosylated hemoglobin (HbA1c), Change in mean daily serum glucose concentrations and Number of subjects with a change in the control of diabetes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in 55 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tesamorelin compound page, all human trials.