Tags

Type your tag names separated by a space and hit enter

Impact of lixisenatide dose range on clinical outcomes with fixed-ratio combination iGlarLixi in patients with type 2 diabetes.
Curr Med Res Opin. 2019 04; 35(4):689-695.CM

Abstract

OBJECTIVE

To evaluate the lixisenatide dose range delivered by the iGlarLixi SoloSTAR pen (5-20 µg), alone or in fixed-ratio combination with insulin glargine (iGlar; iGlarLixi).

METHODS

Data from three clinical studies were analyzed to assess lixisenatide efficacy and safety: a phase 2a trial assessing gastric emptying effects (ACT6011); a phase 2b dose-ranging trial (DRI6012); and a randomized controlled phase 3 trial comparing iGlarLixi with its components of iGlar and lixisenatide (LixiLan-O). Efficacy metrics included glycated hemoglobin A1c (A1C), post-prandial glucose (PPG) values following a standardized breakfast, fasting plasma glucose (FPG), and weight change. Occurrence of gastrointestinal adverse events was also assessed.

RESULTS

ACT6011: lixisenatide doses from 5-20 μg once daily (QD) suppressed PPG; maximal reductions in mean PPG area under the curve were achieved with doses ≥12.5 µg QD, but doses as low as 5 μg achieved 44% of maximal reduction. DRI6012: lixisenatide doses 5-20 μg QD resulted in significant, dose-dependent decreases in A1C, percentage of patients achieving A1C <7.0%, and 2-h PPG levels; doses of 20 μg achieved complete suppression of PPG. LixiLan-O: iGlarLixi decreased 2-h PPG across the entire dose range. Lixisenatide dose was unrelated to reductions in FPG with iGlarLixi. Similar reductions in A1C were seen with iGlarLixi across all lixisenatide doses.

CONCLUSIONS

This analysis demonstrates the clinical benefit of lixisenatide alone or in the formulation of iGlarLixi over the entire dose range of lixisenatide contained in iGlarLixi (5-20 µg), supporting the selection of the lixisenatide dose range delivered by the iGlarLixi SoloSTAR pen.

Authors+Show Affiliations

a National Research Institute , Los Angeles , CA , USA.b Sanofi Germany , Frankfurt , Germany.c Sanofi US, Inc. , Bridgewater , NJ , USA.c Sanofi US, Inc. , Bridgewater , NJ , USA.b Sanofi Germany , Frankfurt , Germany.c Sanofi US, Inc. , Bridgewater , NJ , USA.d Abington Family Medicine , Jenkintown , PA , USA.

Pub Type(s)

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

Language

eng

PubMed ID

30360647

Citation

Pablo Frias, Juan, et al. "Impact of Lixisenatide Dose Range On Clinical Outcomes With Fixed-ratio Combination iGlarLixi in Patients With Type 2 Diabetes." Current Medical Research and Opinion, vol. 35, no. 4, 2019, pp. 689-695.
Pablo Frias J, Lorenz M, Roberts M, et al. Impact of lixisenatide dose range on clinical outcomes with fixed-ratio combination iGlarLixi in patients with type 2 diabetes. Curr Med Res Opin. 2019;35(4):689-695.
Pablo Frias, J., Lorenz, M., Roberts, M., Dex, T., Schmider, W., Hurst, W., & Skolnik, N. (2019). Impact of lixisenatide dose range on clinical outcomes with fixed-ratio combination iGlarLixi in patients with type 2 diabetes. Current Medical Research and Opinion, 35(4), 689-695. https://doi.org/10.1080/03007995.2018.1541316
Pablo Frias J, et al. Impact of Lixisenatide Dose Range On Clinical Outcomes With Fixed-ratio Combination iGlarLixi in Patients With Type 2 Diabetes. Curr Med Res Opin. 2019;35(4):689-695. PubMed PMID: 30360647.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of lixisenatide dose range on clinical outcomes with fixed-ratio combination iGlarLixi in patients with type 2 diabetes. AU - Pablo Frias,Juan, AU - Lorenz,Martin, AU - Roberts,Michelle, AU - Dex,Terry, AU - Schmider,Wolfgang, AU - Hurst,William, AU - Skolnik,Neil, Y1 - 2018/12/06/ PY - 2018/10/27/pubmed PY - 2020/3/11/medline PY - 2018/10/27/entrez KW - Fixed-ratio combination insulin/GLP-1 receptor agonist KW - Insulin glargine KW - Lixisenatide KW - iGlarLixi SP - 689 EP - 695 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 35 IS - 4 N2 - OBJECTIVE: To evaluate the lixisenatide dose range delivered by the iGlarLixi SoloSTAR pen (5-20 µg), alone or in fixed-ratio combination with insulin glargine (iGlar; iGlarLixi). METHODS: Data from three clinical studies were analyzed to assess lixisenatide efficacy and safety: a phase 2a trial assessing gastric emptying effects (ACT6011); a phase 2b dose-ranging trial (DRI6012); and a randomized controlled phase 3 trial comparing iGlarLixi with its components of iGlar and lixisenatide (LixiLan-O). Efficacy metrics included glycated hemoglobin A1c (A1C), post-prandial glucose (PPG) values following a standardized breakfast, fasting plasma glucose (FPG), and weight change. Occurrence of gastrointestinal adverse events was also assessed. RESULTS: ACT6011: lixisenatide doses from 5-20 μg once daily (QD) suppressed PPG; maximal reductions in mean PPG area under the curve were achieved with doses ≥12.5 µg QD, but doses as low as 5 μg achieved 44% of maximal reduction. DRI6012: lixisenatide doses 5-20 μg QD resulted in significant, dose-dependent decreases in A1C, percentage of patients achieving A1C <7.0%, and 2-h PPG levels; doses of 20 μg achieved complete suppression of PPG. LixiLan-O: iGlarLixi decreased 2-h PPG across the entire dose range. Lixisenatide dose was unrelated to reductions in FPG with iGlarLixi. Similar reductions in A1C were seen with iGlarLixi across all lixisenatide doses. CONCLUSIONS: This analysis demonstrates the clinical benefit of lixisenatide alone or in the formulation of iGlarLixi over the entire dose range of lixisenatide contained in iGlarLixi (5-20 µg), supporting the selection of the lixisenatide dose range delivered by the iGlarLixi SoloSTAR pen. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/30360647/Impact_of_lixisenatide_dose_range_on_clinical_outcomes_with_fixed_ratio_combination_iGlarLixi_in_patients_with_type_2_diabetes_ L2 - http://www.tandfonline.com/doi/full/10.1080/03007995.2018.1541316 DB - PRIME DP - Unbound Medicine ER -