th9507 and Diabetes-Mellitus--Type-2

Theratechnologies, under license from Valeant, is developing tesamorelin as a potential vaccine adjuvant and for the potential treatment of wasting, hip fracture recovery, immune disorders, HIV-related lipodystrophy, sleep maintenance insomnia and mild cognitive impairment. Phase III clinical trials for the treatment of HIV-associated lipodystrophy and phase II clinical trials for sleep disorder, chronic obstructive pulmonary disorder, hip fracture and immune system dysfunction are underway. Phase II trials are also assessing the influenza vaccination immune response and cognitive effects of tesamorelin.

Topics: Adjuvants, Immunologic; Animals; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Cognition Disorders; Contraindications; Diabetes Mellitus, Type 2; Growth Hormone-Releasing Hormone; Hip Fractures; HIV Wasting Syndrome; HIV-Associated Lipodystrophy Syndrome; Humans; Lipid Metabolism; Peptides; Recombinant Proteins; Sleep Wake Disorders; Structure-Activity Relationship

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.. A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes. Three treatment groups: placebo, 1 and 2 mg tesamorelin.. Fasting glucose, glucose and insulin from oral glucose tolerance test, glycosylated hemoglobin (HbA1c), home blood glucose, insulin-like growth factor-1, and lipids.. Relative insulin response following oral ingestion of glucose.. 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.. Treatment of type 2 diabetic patients with tesamorelin for 12 weeks did not alter insulin response or glycemic control.. ClinicalTrials.gov NCT01264497.

Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Growth Hormone-Releasing Hormone; Humans; Insulin Resistance; Insulin-Like Growth Factor I; Lipids; Male; Middle Aged