Efficacy and safety of exenatide as add-on therapy for patients with type 2 diabetes with an intensive insulin regimen : A randomized double-blind trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11140%2F21%3A10417470" target="_blank" >RIV/00216208:11140/21:10417470 - isvavai.cz</a>

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=28KW9rfJG0" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=28KW9rfJG0</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/dom.14225" target="_blank" >10.1111/dom.14225</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and safety of exenatide as add-on therapy for patients with type 2 diabetes with an intensive insulin regimen : A randomized double-blind trial

Popis výsledku v původním jazyce

Aim: To assess the safety and efficacy of the short-acting glucagon-like peptide-1 receptor agonist exenatide on a population of patients with type 2 diabetes (T2D) mostly treated with continuous subcutaneous insulin injection (CSII). Materials and methods: A phase 2/3, multicentre, randomized, parallel-group, double-blind, placebo-controlled, 6-month trial was conducted. Patients were randomized to receive subcutaneous (SC) injections of exenatide (10 μg BID) or matched placebo. Results: A total of 46 patients with T2D and elevated HbA1c were randomized (42% of the planned sample size): exenatide (n = 28) and placebo (n = 18). CSII treatment was used by 75% and 89% of patients of the exenatide and placebo groups, respectively. At 6 months, the change in HbA1c was -0.62% +- 0.94% and 0.08% +- 0.81% in the exenatide and placebo groups, respectively (difference, -0.70%; 95% CI [-1.24%; -0.15%], P = .014); body weight and body mass index decreased in the exenatide group (-2.55 +- 3.25 kg and -1.00 +- 1.31 kg/m2 ) and increased in the placebo group (1.29 +- 2.82 kg and 0.46 +- 1.16 kg/m2 ) (observed difference, -3.85 and -1.45, respectively, both P &lt; .001); the postdinner capillary blood glucose value was lower in the exenatide group compared with the placebo group (162.4 +- 80.5 vs. 259.1 +- 94.4 mg/dL, respectively; observed difference, -96.7, P &lt; .01). Hypoglycaemic risk, quality of life and overall safety were not different between the groups, apart from the expected occurrence of digestive effects in the exenatide group. Conclusions: Although we failed to reach our planned sample size, the addition of exenatide treatment 10 μg BID SC in T2D patients with uncontrolled HbA1c despite an intensified insulin regimen, resulted in a significant reduction of HbA1c and body weight with a good overall safety profile and acceptance.

Název v anglickém jazyce

Efficacy and safety of exenatide as add-on therapy for patients with type 2 diabetes with an intensive insulin regimen : A randomized double-blind trial

Popis výsledku anglicky

Aim: To assess the safety and efficacy of the short-acting glucagon-like peptide-1 receptor agonist exenatide on a population of patients with type 2 diabetes (T2D) mostly treated with continuous subcutaneous insulin injection (CSII). Materials and methods: A phase 2/3, multicentre, randomized, parallel-group, double-blind, placebo-controlled, 6-month trial was conducted. Patients were randomized to receive subcutaneous (SC) injections of exenatide (10 μg BID) or matched placebo. Results: A total of 46 patients with T2D and elevated HbA1c were randomized (42% of the planned sample size): exenatide (n = 28) and placebo (n = 18). CSII treatment was used by 75% and 89% of patients of the exenatide and placebo groups, respectively. At 6 months, the change in HbA1c was -0.62% +- 0.94% and 0.08% +- 0.81% in the exenatide and placebo groups, respectively (difference, -0.70%; 95% CI [-1.24%; -0.15%], P = .014); body weight and body mass index decreased in the exenatide group (-2.55 +- 3.25 kg and -1.00 +- 1.31 kg/m2 ) and increased in the placebo group (1.29 +- 2.82 kg and 0.46 +- 1.16 kg/m2 ) (observed difference, -3.85 and -1.45, respectively, both P &lt; .001); the postdinner capillary blood glucose value was lower in the exenatide group compared with the placebo group (162.4 +- 80.5 vs. 259.1 +- 94.4 mg/dL, respectively; observed difference, -96.7, P &lt; .01). Hypoglycaemic risk, quality of life and overall safety were not different between the groups, apart from the expected occurrence of digestive effects in the exenatide group. Conclusions: Although we failed to reach our planned sample size, the addition of exenatide treatment 10 μg BID SC in T2D patients with uncontrolled HbA1c despite an intensified insulin regimen, resulted in a significant reduction of HbA1c and body weight with a good overall safety profile and acceptance.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30202 - Endocrinology and metabolism (including diabetes, hormones)

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Diabetes, Obesity &amp; Metabolism

ISSN

1462-8902

e-ISSN

—

Svazek periodika

23

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

8

Strana od-do

374-381

Kód UT WoS článku

000585062100001

EID výsledku v databázi Scopus

2-s2.0-85094630678