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Pharmacodynamics of the glucagon-like peptide-1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin.
Diabetes Obes Metab. 2014 Aug; 16(8):739-47.DO

Abstract

AIMS

The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin.

METHODS

This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID). The primary endpoint was change in postprandial plasma glucose (PPG) area under the curve (AUC)[0:29-4:30 h] after a standardized breakfast at the highest tolerated lixisenatide dose. Change from baseline in glycated haemoglobin (HbA1c), 2-h PPG and fasting plasma glucose (FPG) were assessed, as were adverse events.

RESULTS

Change from baseline in PPG AUC[0:29-4:30 h] with lixisenatide QD and BID was significantly greater than placebo (p < 0.0001 for all study populations), with particularly prominent effects in Japanese patients. Greater reductions in PPG AUC[0:29-4:30 h] were seen with lixisenatide QD versus BID, while the totality of evidence suggested that the lixisenatide 20 µg dose was optimal. In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all). Lixisenatide was well tolerated.

CONCLUSIONS

Lixisenatide significantly reduced PPG AUC[0:29-4:30 h] versus placebo at the highest well-tolerated dose in patients with T2DM treated with sulphonylureas with/without metformin and had a good safety and tolerability profile. Japanese patients experienced particular benefits with lixisenatide in terms of reductions in PPG excursions.

Authors+Show Affiliations

Kansai Electric Power Hospital, Osaka, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24524806

Citation

Seino, Y, et al. "Pharmacodynamics of the Glucagon-like Peptide-1 Receptor Agonist Lixisenatide in Japanese and Caucasian Patients With Type 2 Diabetes Mellitus Poorly Controlled On Sulphonylureas With/without Metformin." Diabetes, Obesity & Metabolism, vol. 16, no. 8, 2014, pp. 739-47.
Seino Y, Takami A, Boka G, et al. Pharmacodynamics of the glucagon-like peptide-1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin. Diabetes Obes Metab. 2014;16(8):739-47.
Seino, Y., Takami, A., Boka, G., Niemoeller, E., & Raccah, D. (2014). Pharmacodynamics of the glucagon-like peptide-1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin. Diabetes, Obesity & Metabolism, 16(8), 739-47. https://doi.org/10.1111/dom.12276
Seino Y, et al. Pharmacodynamics of the Glucagon-like Peptide-1 Receptor Agonist Lixisenatide in Japanese and Caucasian Patients With Type 2 Diabetes Mellitus Poorly Controlled On Sulphonylureas With/without Metformin. Diabetes Obes Metab. 2014;16(8):739-47. PubMed PMID: 24524806.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmacodynamics of the glucagon-like peptide-1 receptor agonist lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus poorly controlled on sulphonylureas with/without metformin. AU - Seino,Y, AU - Takami,A, AU - Boka,G, AU - Niemoeller,E, AU - Raccah,D, AU - ,, Y1 - 2014/03/12/ PY - 2013/11/05/received PY - 2013/12/12/revised PY - 2014/02/06/accepted PY - 2014/2/15/entrez PY - 2014/2/15/pubmed PY - 2015/3/31/medline KW - Caucasian KW - Japanese KW - lixisenatide KW - prandial KW - type 2 diabetes mellitus SP - 739 EP - 47 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 16 IS - 8 N2 - AIMS: The PDY6797 study evaluated efficacy, safety and pharmacodynamics of lixisenatide in Japanese and Caucasian patients with type 2 diabetes mellitus (T2DM) insufficiently controlled with sulphonylureas with/without metformin. METHODS: This randomized, double-blind, placebo-controlled trial comprised a single-dose assessment of lixisenatide 5 and 10 µg, and a 5- to 6-week repeated dose-escalation assessment of lixisenatide 5 to 30 µg once (QD) or twice daily (BID). The primary endpoint was change in postprandial plasma glucose (PPG) area under the curve (AUC)[0:29-4:30 h] after a standardized breakfast at the highest tolerated lixisenatide dose. Change from baseline in glycated haemoglobin (HbA1c), 2-h PPG and fasting plasma glucose (FPG) were assessed, as were adverse events. RESULTS: Change from baseline in PPG AUC[0:29-4:30 h] with lixisenatide QD and BID was significantly greater than placebo (p < 0.0001 for all study populations), with particularly prominent effects in Japanese patients. Greater reductions in PPG AUC[0:29-4:30 h] were seen with lixisenatide QD versus BID, while the totality of evidence suggested that the lixisenatide 20 µg dose was optimal. In the overall population, changes from baseline for 2-h PPG, HbA1c and FPG were significant with lixisenatide QD and BID versus placebo (p < 0.01 for all). Lixisenatide was well tolerated. CONCLUSIONS: Lixisenatide significantly reduced PPG AUC[0:29-4:30 h] versus placebo at the highest well-tolerated dose in patients with T2DM treated with sulphonylureas with/without metformin and had a good safety and tolerability profile. Japanese patients experienced particular benefits with lixisenatide in terms of reductions in PPG excursions. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/24524806/Pharmacodynamics_of_the_glucagon_like_peptide_1_receptor_agonist_lixisenatide_in_Japanese_and_Caucasian_patients_with_type_2_diabetes_mellitus_poorly_controlled_on_sulphonylureas_with/without_metformin_ L2 - https://doi.org/10.1111/dom.12276 DB - PRIME DP - Unbound Medicine ER -