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Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial.
Diabetes Care. 2016 Nov; 39(11):1972-1980.DC

Abstract

OBJECTIVE

This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents.

RESEARCH DESIGN AND METHODS

After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m2) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum dose of 60 units/day. The primary outcome was change in HbA1c levels at 30 weeks.

RESULTS

HbA1c decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA1c from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA1c of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA1c <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi.

CONCLUSIONS

Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes.

Authors+Show Affiliations

Medstar Health Research Institute, Hyattsville, MD vanita.aroda@medstar.net.Dallas Diabetes Research Center at Medical City, Dallas, TX.Rockwood Clinic, Spokane, WA.Catalina Research Institute, Chino, CA.Complejo Hospitalario Universitario de Ferrol, A Coruña University, A Coruña, Spain.Instituto Jalisciense de Investigación en Diabetes y Obesidad S. C., Universidad de Guadalajara, Hospital Civil de Guadalajara "Dr. Juan I. Menchaca," Guadalajara, Mexico.Sanofi, Tokyo, Japan.Biostatistics, BMD Consulting Inc., Somerset, NJ.Diabetes Division, Sanofi, Frankfurt, Germany.Diabetes Division, Sanofi, Paris, France.International Diabetes Center, Park Nicollet Health Services, Minneapolis, MN.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27650977

Citation

Aroda, Vanita R., et al. "Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled On Basal Insulin and Metformin: the LixiLan-L Randomized Trial." Diabetes Care, vol. 39, no. 11, 2016, pp. 1972-1980.
Aroda VR, Rosenstock J, Wysham C, et al. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care. 2016;39(11):1972-1980.
Aroda, V. R., Rosenstock, J., Wysham, C., Unger, J., Bellido, D., González-Gálvez, G., Takami, A., Guo, H., Niemoeller, E., Souhami, E., & Bergenstal, R. M. (2016). Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. Diabetes Care, 39(11), 1972-1980.
Aroda VR, et al. Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled On Basal Insulin and Metformin: the LixiLan-L Randomized Trial. Diabetes Care. 2016;39(11):1972-1980. PubMed PMID: 27650977.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide in Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin: The LixiLan-L Randomized Trial. AU - Aroda,Vanita R, AU - Rosenstock,Julio, AU - Wysham,Carol, AU - Unger,Jeffrey, AU - Bellido,Diego, AU - González-Gálvez,Guillermo, AU - Takami,Akane, AU - Guo,Hailing, AU - Niemoeller,Elisabeth, AU - Souhami,Elisabeth, AU - Bergenstal,Richard M, AU - ,, Y1 - 2016/09/20/ PY - 2016/07/11/received PY - 2016/08/23/accepted PY - 2016/9/22/pubmed PY - 2017/10/6/medline PY - 2016/9/22/entrez SP - 1972 EP - 1980 JF - Diabetes care JO - Diabetes Care VL - 39 IS - 11 N2 - OBJECTIVE: This study was conducted to demonstrate the efficacy and safety of LixiLan (iGlarLixi), a novel, titratable, fixed-ratio combination of insulin glargine (iGlar) (100 units) and lixisenatide, compared with iGlar in patients with type 2 diabetes inadequately controlled on basal insulin with or without up to two oral glucose-lowering agents. RESEARCH DESIGN AND METHODS: After a 6-week run-in when iGlar was introduced and/or further titrated, and oral antidiabetic drugs other than metformin were stopped, 736 basal insulin-treated patients (mean diabetes duration 12 years, BMI 31 kg/m2) were randomized 1:1 to open-label, once-daily iGlarLixi or iGlar, both titrated to fasting plasma glucose <100 mg/dL (<5.6 mmol/L) up to a maximum dose of 60 units/day. The primary outcome was change in HbA1c levels at 30 weeks. RESULTS: HbA1c decreased from 8.5% (69 mmol/mol) to 8.1% (65 mmol/mol) during the run-in period. After randomization, iGlarLixi showed greater reductions in HbA1c from baseline compared with iGlar (-1.1% vs. -0.6%, P < 0.0001), reaching a mean final HbA1c of 6.9% (52 mmol/mol) compared with 7.5% (58 mmol/mol) for iGlar. HbA1c <7.0% (53 mmol/mol) was achieved in 55% of iGlarLixi patients compared with 30% on iGlar. Mean body weight decreased by 0.7 kg with iGlarLixi and increased by 0.7 kg with iGlar (1.4 kg difference, P < 0.0001). Documented symptomatic hypoglycemia (≤70 mg/dL) was comparable between groups. Mild gastrointestinal adverse effects were very low but more frequent with iGlarLixi. CONCLUSIONS: Compared with iGlar, a substantially higher proportion of iGlarLixi-treated patients achieved glycemic targets with a beneficial effect on body weight, no additional risk of hypoglycemia, and low levels of gastrointestinal adverse effects in inadequately controlled, basal insulin-treated, long-standing type 2 diabetes. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/27650977/Efficacy_and_Safety_of_LixiLan_a_Titratable_Fixed_Ratio_Combination_of_Insulin_Glargine_Plus_Lixisenatide_in_Type_2_Diabetes_Inadequately_Controlled_on_Basal_Insulin_and_Metformin:_The_LixiLan_L_Randomized_Trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=27650977 DB - PRIME DP - Unbound Medicine ER -