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Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.
Diabetes Care. 2020 Jun; 43(6):1249-1257.DC

Abstract

OBJECTIVE

To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).

RESEARCH DESIGN AND METHODS

In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA1c at week 26.

RESULTS

Change in HbA1c from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], P < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA1c <7% (53 mmol/mol) (65.2% vs. 19.4%; P < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference -2.29 mmol/L [-41.23 mg/dL], P < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.

CONCLUSIONS

This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.

Authors+Show Affiliations

Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan hwatada@juntendo.ac.jp.Research & Development, Sanofi K.K., Tokyo, Japan.Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.Research & Development, Sanofi K.K., Tokyo, Japan.Research & Development, Sanofi K.K., Tokyo, Japan.Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32295808

Citation

Watada, Hirotaka, et al. "Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled On Oral Antidiabetic Drugs: the LixiLan JP-O1 Randomized Clinical Trial." Diabetes Care, vol. 43, no. 6, 2020, pp. 1249-1257.
Watada H, Takami A, Spranger R, et al. Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. Diabetes Care. 2020;43(6):1249-1257.
Watada, H., Takami, A., Spranger, R., Amano, A., Hashimoto, Y., & Niemoeller, E. (2020). Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. Diabetes Care, 43(6), 1249-1257. https://doi.org/10.2337/dc19-2452
Watada H, et al. Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled On Oral Antidiabetic Drugs: the LixiLan JP-O1 Randomized Clinical Trial. Diabetes Care. 2020;43(6):1249-1257. PubMed PMID: 32295808.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial. AU - Watada,Hirotaka, AU - Takami,Akane, AU - Spranger,Robert, AU - Amano,Atsushi, AU - Hashimoto,Yasuhiro, AU - Niemoeller,Elisabeth, Y1 - 2020/04/15/ PY - 2019/12/06/received PY - 2020/03/20/accepted PY - 2020/4/17/pubmed PY - 2020/4/17/medline PY - 2020/4/17/entrez SP - 1249 EP - 1257 JF - Diabetes care JO - Diabetes Care VL - 43 IS - 6 N2 - OBJECTIVE: To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs). RESEARCH DESIGN AND METHODS: In this phase 3, open-label, multicenter trial, 321 patients with HbA1c≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA1c at week 26. RESULTS: Change in HbA1c from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], P < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA1c <7% (53 mmol/mol) (65.2% vs. 19.4%; P < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference -2.29 mmol/L [-41.23 mg/dL], P < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar. CONCLUSIONS: This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/32295808/Efficacy_and_Safety_of_1:1_Fixed-Ratio_Combination_of_Insulin_Glargine_and_Lixisenatide_Versus_Lixisenatide_in_Japanese_Patients_With_Type_2_Diabetes_Inadequately_Controlled_on_Oral_Antidiabetic_Drugs:_The_LixiLan_JP-O1_Randomized_Clinical_Trial L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=32295808 DB - PRIME DP - Unbound Medicine ER -
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