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

David R Clemmons, Sam Miller, Jean-Claude Mamputu, David R Clemmons, Sam Miller, Jean-Claude Mamputu

Abstract

Objective: Use of growth hormone is associated with side effects, including insulin resistance. The objective of this study was to determine whether tesamorelin, a stabilized growth hormone-releasing hormone analogue, would alter insulin sensitivity or control of diabetes.

Design: A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes. Three treatment groups: placebo, 1 and 2 mg tesamorelin.

Measurements: Fasting glucose, glucose and insulin from oral glucose tolerance test, glycosylated hemoglobin (HbA1c), home blood glucose, insulin-like growth factor-1, and lipids.

Main outcome measure: Relative insulin response following oral ingestion of glucose.

Results: No significant differences were observed between groups in relative insulin response over the 12-week treatment period. At Week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups. In addition, relevant modifications in diabetes medications were similar between groups. Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p<0.05 vs. placebo). No patient discontinued the study due to loss of diabetes control.

Conclusions: Treatment of type 2 diabetic patients with tesamorelin for 12 weeks did not alter insulin response or glycemic control.

Trial registration: ClinicalTrials.gov NCT01264497.

Conflict of interest statement

Competing Interests: We have the following interests. Theratechnologies Inc. sponsored the study. Jean-Claude Mamputu is employed by Theratechnologies Inc. David R Clemmons has received fees for consultancy from Theratechnologies Inc. at the time the study was performed. There are no patents, products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Figures

Fig 1. CONSORT flow diagram of the…
Fig 1. CONSORT flow diagram of the clinical study.
Patient enrollment and outcomes.

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