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Effects of lixisenatide once daily on gastric emptying in type 2 diabetes--relationship to postprandial glycemia.
Regul Pept. 2013 Aug 10; 185:1-8.RP

Abstract

OBJECTIVES

To determine the effects of lixisenatide, a new once-daily (QD) glucagon-like peptide-1 receptor agonist, on postprandial glucose (PPG) and gastric emptying, and the relationship between these effects in patients with type 2 diabetes mellitus (T2DM).

METHODS

Data were obtained from a randomized, double-blind, placebo-controlled, parallel-group study with treatment duration of 28 days in patients with T2DM receiving ≤2 oral antidiabetic drugs. Lixisenatide was injected subcutaneously using an ascending dose range (5-20 μg) increased every fifth day in increments of 2.5 μg. Blood glucose was determined before and after three standardized meals (breakfast, lunch, and dinner). Gastric emptying of the standardized breakfast was determined by a (13)C-octanoic acid breath test at baseline (Day-1) and at Day 28.

RESULTS

A total of 21 and 22 patients were randomized to lixisenatide 20 μg QD and placebo, respectively. With lixisenatide 20 μg QD, there was a reduction in PPG when compared with placebo after breakfast (p<0.0001), lunch (p<0.001) and dinner (p<0.05). Hence, lixisenatide 20 μg administered in the morning exhibited a pharmacodynamic effect on blood glucose throughout the day. Gastric emptying (50% emptying time) increased substantially from baseline with lixisenatide 20 μg QD, but not with placebo (change from baseline ± SD: -24.1 ± 133.1 min for placebo and 211.5 ± 278.5 min for lixisenatide; p<0.01). There was an inverse relationship between PPG area under the curve after breakfast and gastric emptying with lixisenatide 20 μg QD (n=17, r(2)=0.51, p<0.05), but not with placebo.

CONCLUSIONS

In this study, lixisenatide at a dose of 20 μg QD reduced postprandial glycemic excursions in patients with T2DM, possibly as a result of sustained slowing of gastric emptying.

Authors+Show Affiliations

Sanofi, Frankfurt am Main, Germany. Electronic address: martin.lorenz@sanofi.com.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23665027

Citation

Lorenz, Martin, et al. "Effects of Lixisenatide once Daily On Gastric Emptying in Type 2 Diabetes--relationship to Postprandial Glycemia." Regulatory Peptides, vol. 185, 2013, pp. 1-8.
Lorenz M, Pfeiffer C, Steinsträsser A, et al. Effects of lixisenatide once daily on gastric emptying in type 2 diabetes--relationship to postprandial glycemia. Regul Pept. 2013;185:1-8.
Lorenz, M., Pfeiffer, C., Steinsträsser, A., Becker, R. H., Rütten, H., Ruus, P., & Horowitz, M. (2013). Effects of lixisenatide once daily on gastric emptying in type 2 diabetes--relationship to postprandial glycemia. Regulatory Peptides, 185, 1-8. https://doi.org/10.1016/j.regpep.2013.04.001
Lorenz M, et al. Effects of Lixisenatide once Daily On Gastric Emptying in Type 2 Diabetes--relationship to Postprandial Glycemia. Regul Pept. 2013 Aug 10;185:1-8. PubMed PMID: 23665027.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of lixisenatide once daily on gastric emptying in type 2 diabetes--relationship to postprandial glycemia. AU - Lorenz,Martin, AU - Pfeiffer,Claudia, AU - Steinsträsser,Axel, AU - Becker,Reinhard H A, AU - Rütten,Hartmut, AU - Ruus,Peter, AU - Horowitz,Michael, Y1 - 2013/05/09/ PY - 2012/11/28/received PY - 2013/03/22/revised PY - 2013/04/26/accepted PY - 2013/5/14/entrez PY - 2013/5/15/pubmed PY - 2014/4/22/medline KW - Gastric emptying KW - Glucagon-like peptide-1 receptor agonist KW - Lixisenatide KW - Postprandial blood glucose KW - Type 2 diabetes SP - 1 EP - 8 JF - Regulatory peptides JO - Regul. Pept. VL - 185 N2 - OBJECTIVES: To determine the effects of lixisenatide, a new once-daily (QD) glucagon-like peptide-1 receptor agonist, on postprandial glucose (PPG) and gastric emptying, and the relationship between these effects in patients with type 2 diabetes mellitus (T2DM). METHODS: Data were obtained from a randomized, double-blind, placebo-controlled, parallel-group study with treatment duration of 28 days in patients with T2DM receiving ≤2 oral antidiabetic drugs. Lixisenatide was injected subcutaneously using an ascending dose range (5-20 μg) increased every fifth day in increments of 2.5 μg. Blood glucose was determined before and after three standardized meals (breakfast, lunch, and dinner). Gastric emptying of the standardized breakfast was determined by a (13)C-octanoic acid breath test at baseline (Day-1) and at Day 28. RESULTS: A total of 21 and 22 patients were randomized to lixisenatide 20 μg QD and placebo, respectively. With lixisenatide 20 μg QD, there was a reduction in PPG when compared with placebo after breakfast (p<0.0001), lunch (p<0.001) and dinner (p<0.05). Hence, lixisenatide 20 μg administered in the morning exhibited a pharmacodynamic effect on blood glucose throughout the day. Gastric emptying (50% emptying time) increased substantially from baseline with lixisenatide 20 μg QD, but not with placebo (change from baseline ± SD: -24.1 ± 133.1 min for placebo and 211.5 ± 278.5 min for lixisenatide; p<0.01). There was an inverse relationship between PPG area under the curve after breakfast and gastric emptying with lixisenatide 20 μg QD (n=17, r(2)=0.51, p<0.05), but not with placebo. CONCLUSIONS: In this study, lixisenatide at a dose of 20 μg QD reduced postprandial glycemic excursions in patients with T2DM, possibly as a result of sustained slowing of gastric emptying. SN - 1873-1686 UR - https://www.unboundmedicine.com/medline/citation/23665027/Effects_of_lixisenatide_once_daily_on_gastric_emptying_in_type_2_diabetes__relationship_to_postprandial_glycemia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0167-0115(13)00077-3 DB - PRIME DP - Unbound Medicine ER -