Abstract
STUDY OBJECTIVE To evaluate the effects of exenatide on some inflammatory markers and to quantify the effect of exenatide on b-cell function. DESIGN A randomized, double-blind, placebo-controlled trial. SETTING Seven hospitals in Italy. PATIENTS A total of 174 white treatment-naive adults with type 2 diabetes and a glycated hemoglobin (HbA1c) level higher than 7.5%. INTERVENTION After an open-label run-in period of 8-2 months with metformin, patients were randomized to take exenatide (5 lg twice/day for the first 4 weeks, 10 lg twice/day thereafter) or a placebo volume equivalent for 12 months. MEASUREMENTS AND MAIN RESULTS Body mass index, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index, homeostasis model assessment b-cell function index (HOMA-b), fasting plasma proinsulin (FPPr), proinsulin-to-fasting plasma insulin ratio (Pr:FPI ratio), C-peptide, glucagon, vaspin, chemerin, and resistin were evaluated at baseline, at randomization, and at 3, 6, 9, and 12 months. Patients also underwent a combined euglycemic, hyperinsulinemic, and hyperglycemic clamp with subsequent arginine stimulation to assess insulin sensitivity and insulin secretion. HbA1c was significantly improved with exenatide plus metformin compared with placebo plus metformin. Exenatide plus metformin was also significantly more effective than placebo plus metformin in increasing HOMA-b C-peptide, and all measures of b-cell function after the euglycemic hyperinsulinemic and hyperglycemic clamp. We observed that exenatide plus metformin also reduced resistin compared with placebo plus metformin. No variations in vaspin and chemerin were noted in group-to-group comparisons. We observed a significant correlation between M value increase, an index of insulin sensitivity, and a decrease in inflammatory parameters in the exenatide plus metformin group. CONCLUSIONS The combination of exenatide plus metformin was more effective than metformin alone in improving glycemic control, b-cell function, and inflammatory parameters.
| Original language | English |
|---|---|
| Pages (from-to) | 817-826 |
| Number of pages | 10 |
| Journal | Pharmacotherapy |
| Volume | 33 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - Aug 2013 |
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Keywords
- Chemerin
- Exenatide
- Glycemic control
- Inflammation
- Metformin
- Resistin
- Vaspin
ASJC Scopus subject areas
- Pharmacology (medical)
Cite this
Variation in inflammatory markers and glycemic parameters after 12 months of exenatide plus metformin treatment compared with metformin alone : A randomized placebo-controlled trial. / Derosa, Giuseppe; Franzetti, Ivano G.; Querci, Fabrizio; Carbone, Anna; Ciccarelli, Leonardina; Piccinni, Mario N.; Fogari, Elena; Maffioli, Pamela.
In: Pharmacotherapy, Vol. 33, No. 8, 08.2013, p. 817-826.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Variation in inflammatory markers and glycemic parameters after 12 months of exenatide plus metformin treatment compared with metformin alone
T2 - A randomized placebo-controlled trial
AU - Derosa, Giuseppe
AU - Franzetti, Ivano G.
AU - Querci, Fabrizio
AU - Carbone, Anna
AU - Ciccarelli, Leonardina
AU - Piccinni, Mario N.
AU - Fogari, Elena
AU - Maffioli, Pamela
PY - 2013/8
Y1 - 2013/8
N2 - STUDY OBJECTIVE To evaluate the effects of exenatide on some inflammatory markers and to quantify the effect of exenatide on b-cell function. DESIGN A randomized, double-blind, placebo-controlled trial. SETTING Seven hospitals in Italy. PATIENTS A total of 174 white treatment-naive adults with type 2 diabetes and a glycated hemoglobin (HbA1c) level higher than 7.5%. INTERVENTION After an open-label run-in period of 8-2 months with metformin, patients were randomized to take exenatide (5 lg twice/day for the first 4 weeks, 10 lg twice/day thereafter) or a placebo volume equivalent for 12 months. MEASUREMENTS AND MAIN RESULTS Body mass index, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index, homeostasis model assessment b-cell function index (HOMA-b), fasting plasma proinsulin (FPPr), proinsulin-to-fasting plasma insulin ratio (Pr:FPI ratio), C-peptide, glucagon, vaspin, chemerin, and resistin were evaluated at baseline, at randomization, and at 3, 6, 9, and 12 months. Patients also underwent a combined euglycemic, hyperinsulinemic, and hyperglycemic clamp with subsequent arginine stimulation to assess insulin sensitivity and insulin secretion. HbA1c was significantly improved with exenatide plus metformin compared with placebo plus metformin. Exenatide plus metformin was also significantly more effective than placebo plus metformin in increasing HOMA-b C-peptide, and all measures of b-cell function after the euglycemic hyperinsulinemic and hyperglycemic clamp. We observed that exenatide plus metformin also reduced resistin compared with placebo plus metformin. No variations in vaspin and chemerin were noted in group-to-group comparisons. We observed a significant correlation between M value increase, an index of insulin sensitivity, and a decrease in inflammatory parameters in the exenatide plus metformin group. CONCLUSIONS The combination of exenatide plus metformin was more effective than metformin alone in improving glycemic control, b-cell function, and inflammatory parameters.
AB - STUDY OBJECTIVE To evaluate the effects of exenatide on some inflammatory markers and to quantify the effect of exenatide on b-cell function. DESIGN A randomized, double-blind, placebo-controlled trial. SETTING Seven hospitals in Italy. PATIENTS A total of 174 white treatment-naive adults with type 2 diabetes and a glycated hemoglobin (HbA1c) level higher than 7.5%. INTERVENTION After an open-label run-in period of 8-2 months with metformin, patients were randomized to take exenatide (5 lg twice/day for the first 4 weeks, 10 lg twice/day thereafter) or a placebo volume equivalent for 12 months. MEASUREMENTS AND MAIN RESULTS Body mass index, HbA1c, fasting plasma glucose, postprandial plasma glucose, fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index, homeostasis model assessment b-cell function index (HOMA-b), fasting plasma proinsulin (FPPr), proinsulin-to-fasting plasma insulin ratio (Pr:FPI ratio), C-peptide, glucagon, vaspin, chemerin, and resistin were evaluated at baseline, at randomization, and at 3, 6, 9, and 12 months. Patients also underwent a combined euglycemic, hyperinsulinemic, and hyperglycemic clamp with subsequent arginine stimulation to assess insulin sensitivity and insulin secretion. HbA1c was significantly improved with exenatide plus metformin compared with placebo plus metformin. Exenatide plus metformin was also significantly more effective than placebo plus metformin in increasing HOMA-b C-peptide, and all measures of b-cell function after the euglycemic hyperinsulinemic and hyperglycemic clamp. We observed that exenatide plus metformin also reduced resistin compared with placebo plus metformin. No variations in vaspin and chemerin were noted in group-to-group comparisons. We observed a significant correlation between M value increase, an index of insulin sensitivity, and a decrease in inflammatory parameters in the exenatide plus metformin group. CONCLUSIONS The combination of exenatide plus metformin was more effective than metformin alone in improving glycemic control, b-cell function, and inflammatory parameters.
KW - Chemerin
KW - Exenatide
KW - Glycemic control
KW - Inflammation
KW - Metformin
KW - Resistin
KW - Vaspin
UR - http://www.scopus.com/inward/record.url?scp=84885231257&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84885231257&partnerID=8YFLogxK
U2 - 10.1002/phar.1301
DO - 10.1002/phar.1301
M3 - Article
VL - 33
SP - 817
EP - 826
JO - Pharmacotherapy
JF - Pharmacotherapy
SN - 0277-0008
IS - 8
ER -