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

PLoS One. 2017 Jun 15;12(6):e0179538. doi: 10.1371/journal.pone.0179538. eCollection 2017.


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: NCT01264497.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Blood Glucose / metabolism*
  • Diabetes Mellitus, Type 2* / blood
  • Diabetes Mellitus, Type 2* / drug therapy
  • Female
  • Glycated Hemoglobin / metabolism*
  • Growth Hormone-Releasing Hormone / administration & dosage
  • Growth Hormone-Releasing Hormone / adverse effects
  • Growth Hormone-Releasing Hormone / analogs & derivatives*
  • Humans
  • Insulin Resistance*
  • Insulin-Like Growth Factor I / metabolism*
  • Lipids / blood*
  • Male
  • Middle Aged


  • Blood Glucose
  • Glycated Hemoglobin A
  • Lipids
  • hemoglobin A1c protein, human
  • Insulin-Like Growth Factor I
  • Growth Hormone-Releasing Hormone
  • tesamorelin

Associated data


Grant support

Theratechnologies Inc. sponsored the study and provided support in the form of salary for author JCM. DRC was a paid consultant of Theratechnologies Inc. at the time the study was performed. SM has no relevant financial disclosure. Theratechnologies did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the "author contributions" section.