Acute and long-term effects of saxagliptin on post-prandial glycemic response in obese patients with impaired glucose tolerance.

Publisher: Elsevier Country of Publication: Netherlands NLM ID: 9111474 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1590-3729 (Electronic) Linking ISSN: 09394753 NLM ISO Abbreviation: Nutr Metab Cardiovasc Dis Subsets: MEDLINE

Publication: 2005- : Amsterdam : Elsevier
Original Publication: [Heidelberg] : Springer International, c1991-

Postprandial Period*; Adamantane/*analogs & derivatives ; Blood Glucose/*drug effects ; Diabetes Mellitus, Type 2/*prevention & control ; Dipeptides/*therapeutic use ; Dipeptidyl-Peptidase IV Inhibitors/*therapeutic use ; Glucose Intolerance/*drug therapy ; Obesity/*complications; Adamantane/adverse effects ; Adamantane/therapeutic use ; Adult ; Biomarkers/blood ; Blood Glucose/metabolism ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/diagnosis ; Diabetes Mellitus, Type 2/etiology ; Dipeptides/adverse effects ; Dipeptidyl-Peptidase IV Inhibitors/adverse effects ; Double-Blind Method ; Female ; France ; Glucose Intolerance/blood ; Glucose Intolerance/diagnosis ; Glucose Intolerance/etiology ; Humans ; Male ; Middle Aged ; Obesity/diagnosis ; Pilot Projects ; Time Factors ; Treatment Outcome

Background and Aims: Dipeptidyl-peptidase inhibitors might be useful in type 2 diabetes prevention. ACCES (ACute and Chronic Effects of Saxagliptin) was a randomized, placebo-controlled, double-blind, controlled phase 2, pilot study aiming to examine in obese patients with impaired glucose tolerance (IGT) the acute effects and the effects after 12 weeks of treatment by saxagliptin on glucose levels at fasting and postprandially after a standard breakfast, and on glucose tolerance.
Methods and Results: We included 24 obese patients with IGT. Patients were randomized to receive saxagliptin 5 mg or placebo in the morning. The treatment was taken on Visit 1 before breakfast, then continued for 12 weeks. Biochemical measurements were performed before, one, two and three hours after a standard breakfast including 75 g of carbohydrates, during Visit 1 and Visit 2 (12 weeks). Glucose variability (GV) was evaluated at Visit 1 from 24-h continuous glucose monitoring including the breakfast. A second OGTT was performed at Visit 3 (3-5 days after Visit 2). Compared with placebo-treated patients, saxagliptin-treated patients had lower 1 h and 2 h post-meal plasma glucose levels at Visit 1 and similar changes at Visit 2 (p < 0.01 to p < 0.004), with lower GV indexes after breakfast at Visit 1. At Visit 3, all patients but one in saxagliptin group and only 4 patients in placebo group turned to normal glucose tolerance. Lower glucose response to breakfast at Visit 1 was predictive of recovery of glucose tolerance.
Conclusion: Saxagliptin has metabolically beneficial effects in glucose-intolerant obese patients by significantly lowering postprandial blood glucose levels.
Clinical Trial Registration Number: NCT01521312: https://clinicaltrials.gov/ct2/show/NCT01521312.
(Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Keywords: CGMS; DPP-4 inhibitors; Glucose variability; Impaired glucose tolerance; OGTT; Obesity; Saxagliptin

ClinicalTrials.gov NCT01521312

0 (Biomarkers)
0 (Blood Glucose)
0 (Dipeptides)
0 (Dipeptidyl-Peptidase IV Inhibitors)
9GB927LAJW (saxagliptin)
PJY633525U (Adamantane)

Date Created: 20210223 Date Completed: 20210405 Latest Revision: 20210405

20240628

10.1016/j.numecd.2020.12.025

33618922