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Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial.
Diabetes Obes Metab. 2018 02; 20(2):335-343.DO

Abstract

AIMS

To assess the effects on glycaemic control of lixisenatide vs placebo as add-on treatment to basal insulin (BI) ± metformin and effects on glycated haemoglobin (HbA1c) reduction in patients with insufficiently controlled type 2 diabetes (T2D).

METHODS

Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L). The primary endpoint was absolute change in HbA1c from baseline to week 24. Secondary efficacy endpoints included: percentage of responders; changes in 2-hour postprandial plasma glucose (PPG); 7-point SMPG (daily average); body weight (BW); total daily BI dose; fasting plasma glucose; and safety assessments.

RESULTS

Baseline demographics were similar in the two treatment groups. After insulin optimization during run-in, lixisenatide was superior to placebo in mean change from baseline (7.9% [standard deviation {s.d.}, 0.66] and 7.9% [0.70], respectively) to week 24 in HbA1c (least squares mean [standard error {s.e.}] change -0.62% [0.09] vs -0.11% [0.09]; P < .0001, respectively) and higher proportions of patients achieved HbA1c targets. Two-hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (-1.12 kg vs 0.04 kg [P < .0001]; -3.0 U vs -1.9 U [P = .0033], respectively). Treatment-emergent adverse events were greater with lixisenatide than placebo (63.8% vs 40.8%, respectively). The incidence of symptomatic hypoglycaemia was similar (lixisenatide 15.6% vs placebo 13.5%).

CONCLUSIONS

In Asian patients insufficiently controlled on BI ± metformin, lixisenatide was superior to placebo in glycaemic control, with a tolerability profile in line with other glucagon-like peptide-1 receptor agonists.

CLINICAL TRIAL NUMBER

NCT01632163 (clinicaltrials.gov).

Authors+Show Affiliations

China-Japan Friendship Hospital, Beijing, China.Eulji General Hospital, Seoul, South Korea.The Second Xiangya Hospital of Central South University, Changsha, China.Shengjing Hospital of China Medical University, Shenyang, China.Fuzhou General Hospital, Fuzhou, China.Nanjing Gulou Hospital, Nanjing, China.MaxCure Hospital, Hyderabad, India.Cauvery Medical Centre, Bengaluru, India.Sanofi, Shanghai, China.Sanofi, Shanghai, China.Diabetes Division, Sanofi, Frankfurt, Germany.Sanofi, Shanghai, China.

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

28742225

Citation

Yang, Wenying, et al. "Efficacy and Safety of Lixisenatide in a Predominantly Asian Population With Type 2 Diabetes Insufficiently Controlled With Basal Insulin: the GetGoal-L-C Randomized Trial." Diabetes, Obesity & Metabolism, vol. 20, no. 2, 2018, pp. 335-343.
Yang W, Min K, Zhou Z, et al. Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial. Diabetes Obes Metab. 2018;20(2):335-343.
Yang, W., Min, K., Zhou, Z., Li, L., Xu, X., Zhu, D., Venkateshwar Rao, A., Murthy, L. S., Zhang, N., Li, I., Niemoeller, E., & Shang, S. (2018). Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial. Diabetes, Obesity & Metabolism, 20(2), 335-343. https://doi.org/10.1111/dom.13072
Yang W, et al. Efficacy and Safety of Lixisenatide in a Predominantly Asian Population With Type 2 Diabetes Insufficiently Controlled With Basal Insulin: the GetGoal-L-C Randomized Trial. Diabetes Obes Metab. 2018;20(2):335-343. PubMed PMID: 28742225.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lixisenatide in a predominantly Asian population with type 2 diabetes insufficiently controlled with basal insulin: The GetGoal-L-C randomized trial. AU - Yang,Wenying, AU - Min,Kyungwan, AU - Zhou,Zhiguang, AU - Li,Ling, AU - Xu,XiangJin, AU - Zhu,Dalong, AU - Venkateshwar Rao,A, AU - Murthy,Laxminarayanappa Sreenivasa, AU - Zhang,Nianxian, AU - Li,Ivy, AU - Niemoeller,Elisabeth, AU - Shang,Shuhua, Y1 - 2017/10/05/ PY - 2017/04/26/received PY - 2017/07/19/revised PY - 2017/07/20/accepted PY - 2017/7/26/pubmed PY - 2018/12/28/medline PY - 2017/7/26/entrez KW - GLP-1 KW - incretin therapy KW - incretins KW - randomized trial SP - 335 EP - 343 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 20 IS - 2 N2 - AIMS: To assess the effects on glycaemic control of lixisenatide vs placebo as add-on treatment to basal insulin (BI) ± metformin and effects on glycated haemoglobin (HbA1c) reduction in patients with insufficiently controlled type 2 diabetes (T2D). METHODS: Patients (n = 448) with inadequately controlled T2D were randomized (1:1) to lixisenatide or placebo as add-on to BI ± metformin for 24 weeks after an 8-week run-in phase, during which BI was titrated to a target self-monitored plasma glucose (SMPG; 4.4-5.6 mmol/L). The primary endpoint was absolute change in HbA1c from baseline to week 24. Secondary efficacy endpoints included: percentage of responders; changes in 2-hour postprandial plasma glucose (PPG); 7-point SMPG (daily average); body weight (BW); total daily BI dose; fasting plasma glucose; and safety assessments. RESULTS: Baseline demographics were similar in the two treatment groups. After insulin optimization during run-in, lixisenatide was superior to placebo in mean change from baseline (7.9% [standard deviation {s.d.}, 0.66] and 7.9% [0.70], respectively) to week 24 in HbA1c (least squares mean [standard error {s.e.}] change -0.62% [0.09] vs -0.11% [0.09]; P < .0001, respectively) and higher proportions of patients achieved HbA1c targets. Two-hour PPG, daily mean SMPG and mean BW were reduced further and daily BI dose was lower with lixisenatide than placebo (-1.12 kg vs 0.04 kg [P < .0001]; -3.0 U vs -1.9 U [P = .0033], respectively). Treatment-emergent adverse events were greater with lixisenatide than placebo (63.8% vs 40.8%, respectively). The incidence of symptomatic hypoglycaemia was similar (lixisenatide 15.6% vs placebo 13.5%). CONCLUSIONS: In Asian patients insufficiently controlled on BI ± metformin, lixisenatide was superior to placebo in glycaemic control, with a tolerability profile in line with other glucagon-like peptide-1 receptor agonists. CLINICAL TRIAL NUMBER: NCT01632163 (clinicaltrials.gov). SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/28742225/Efficacy_and_safety_of_lixisenatide_in_a_predominantly_Asian_population_with_type_2_diabetes_insufficiently_controlled_with_basal_insulin:_The_GetGoal_L_C_randomized_trial_ L2 - https://doi.org/10.1111/dom.13072 DB - PRIME DP - Unbound Medicine ER -