Tags

Type your tag names separated by a space and hit enter

Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study).
Diabetes Obes Metab. 2017 09; 19(9):1252-1259.DO

Abstract

AIM

To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100.

MATERIALS AND METHODS

This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg. The primary endpoint was the change in postprandial glucose (PPG) exposure 4 hours after a standardized breakfast (PPG area under the plasma glucose concentration-time curve [AUC0:00-4:00h ]) from baseline to day 29.

RESULTS

Lixisenatide reduced PPG exposure to a statistically significantly greater extent than sitagliptin: least squares (LS) mean change from baseline in PPG AUC0:00-4:00h was -347.3 h·mg/dL (-19.3 h·mmol/L) in the lixisenatide group and -113.3 h·mg/dL (-6.3 h·mmol/L) in the sitagliptin group (LS mean between-group difference -234.0 h·mg/dL [-13.0 h·mmol/L], 95% confidence interval -285.02 to -183.00 h·mg/dL [-15.8 to -10.2 h·mmol/L]; P < .0001). Lixisenatide led to significantly greater LS mean reductions in maximum PPG excursion than sitagliptin (-122.4 vs -46.6 mg/dL [-6.8 vs -2.6 h·mmol/L]; P < .0001). Change-from-baseline reductions in exposure to C-peptide, fasting glycoalbumin levels, and the gastric emptying rate were greater in the lixisenatide than in the sitagliptin group. The incidence of treatment-emergent adverse events was higher with lixisenatide (60.9%) than with sitagliptin (16.4%), with no serious events or severe hypoglycaemia reported.

CONCLUSION

Lixisenatide reduced PPG significantly more than sitagliptin, when these agents were added to basal insulin glargine U100, and was well tolerated.

Authors+Show Affiliations

Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine and Faculty of Medicine, Akita, Japan.Medical Affairs, Sanofi K.K., Tokyo, Japan.Diabetes and Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.Diabetes and Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.Biostatistics and Programming, Sanofi K.K., Tokyo, Japan.Diabetes and Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.Department of General Medicine and Emergency Care, Toho University School of Medicine, Omori Hospital, Tokyo, Japan.

Pub Type(s)

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

Language

eng

PubMed ID

28345162

Citation

Yamada, Yuichiro, et al. "Reduction of Postprandial Glucose By Lixisenatide Vs Sitagliptin Treatment in Japanese Patients With Type 2 Diabetes On Background Insulin Glargine: a Randomized Phase IV Study (NEXTAGE Study)." Diabetes, Obesity & Metabolism, vol. 19, no. 9, 2017, pp. 1252-1259.
Yamada Y, Senda M, Naito Y, et al. Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes Obes Metab. 2017;19(9):1252-1259.
Yamada, Y., Senda, M., Naito, Y., Tamura, M., Watanabe, D., Shuto, Y., & Urita, Y. (2017). Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes, Obesity & Metabolism, 19(9), 1252-1259. https://doi.org/10.1111/dom.12945
Yamada Y, et al. Reduction of Postprandial Glucose By Lixisenatide Vs Sitagliptin Treatment in Japanese Patients With Type 2 Diabetes On Background Insulin Glargine: a Randomized Phase IV Study (NEXTAGE Study). Diabetes Obes Metab. 2017;19(9):1252-1259. PubMed PMID: 28345162.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). AU - Yamada,Yuichiro, AU - Senda,Masayuki, AU - Naito,Yusuke, AU - Tamura,Masahiro, AU - Watanabe,Daisuke, AU - Shuto,Yujin, AU - Urita,Yoshihisa, Y1 - 2017/04/27/ PY - 2017/01/23/received PY - 2017/03/09/revised PY - 2017/03/12/accepted PY - 2017/3/28/pubmed PY - 2018/5/8/medline PY - 2017/3/28/entrez KW - gastric emptying KW - glucagon-like peptide 1 receptor agonist KW - lixisenatide KW - postprandial glucose KW - randomized trial KW - type 2 diabetes mellitus SP - 1252 EP - 1259 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 19 IS - 9 N2 - AIM: To evaluate the pharmacodynamics of lixisenatide once daily vs sitagliptin once daily in Japanese patients with type 2 diabetes receiving insulin glargine U100. MATERIALS AND METHODS: This multicentre, open-label, phase IV study (NEXTAGE Study; ClinicalTrials.gov number, NCT02200991) randomly assigned 136 patients to either lixisenatide once daily via subcutaneous injection (10 µg initially increased weekly by 5 up to 20 µg) or once-daily oral sitagliptin 50 mg. The primary endpoint was the change in postprandial glucose (PPG) exposure 4 hours after a standardized breakfast (PPG area under the plasma glucose concentration-time curve [AUC0:00-4:00h ]) from baseline to day 29. RESULTS: Lixisenatide reduced PPG exposure to a statistically significantly greater extent than sitagliptin: least squares (LS) mean change from baseline in PPG AUC0:00-4:00h was -347.3 h·mg/dL (-19.3 h·mmol/L) in the lixisenatide group and -113.3 h·mg/dL (-6.3 h·mmol/L) in the sitagliptin group (LS mean between-group difference -234.0 h·mg/dL [-13.0 h·mmol/L], 95% confidence interval -285.02 to -183.00 h·mg/dL [-15.8 to -10.2 h·mmol/L]; P < .0001). Lixisenatide led to significantly greater LS mean reductions in maximum PPG excursion than sitagliptin (-122.4 vs -46.6 mg/dL [-6.8 vs -2.6 h·mmol/L]; P < .0001). Change-from-baseline reductions in exposure to C-peptide, fasting glycoalbumin levels, and the gastric emptying rate were greater in the lixisenatide than in the sitagliptin group. The incidence of treatment-emergent adverse events was higher with lixisenatide (60.9%) than with sitagliptin (16.4%), with no serious events or severe hypoglycaemia reported. CONCLUSION: Lixisenatide reduced PPG significantly more than sitagliptin, when these agents were added to basal insulin glargine U100, and was well tolerated. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/28345162/Reduction_of_postprandial_glucose_by_lixisenatide_vs_sitagliptin_treatment_in_Japanese_patients_with_type_2_diabetes_on_background_insulin_glargine:_A_randomized_phase_IV_study__NEXTAGE_Study__ L2 - https://doi.org/10.1111/dom.12945 DB - PRIME DP - Unbound Medicine ER -