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Efficacy and safety of lixisenatide as add-on therapy to basal insulin in older adults with type 2 diabetes in the GetGoal-O Study.
J Diabetes. 2019 Dec; 11(12):971-981.JD

Abstract

BACKGROUND

This study compared the efficacy and safety of lixisenatide with placebo as add-on therapy to basal insulin (BI) in adults aged ≥70 years with type 2 diabetes (T2D), with or without moderate renal insufficiency.

METHODS

This post hoc analysis evaluated data from non-frail patients with T2D inadequately controlled on BI with or without oral antidiabetic drugs (n = 108), randomized to once-daily lixisenatide 20 μg or placebo for 24 weeks (GetGoal-O Study). The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included changes from baseline in fasting plasma glucose, 2-hour postprandial plasma glucose (PPG), average seven-point self-monitored plasma glucose (SMPG), area under the curve for SMPG, daily BI dose, body weight, proportion of patients achieving HbA1c > 0.5%, and composite endpoints. Safety outcomes included the incidence of documented symptomatic hypoglycemia (plasma glucose <60 mg/dL) and gastrointestinal treatment-emergent adverse events (TEAEs). Outcomes were also analyzed by the occurrence of moderate renal insufficiency.

RESULTS

Compared with placebo, lixisenatide-treated patients had significantly greater reductions in HbA1c, 2-hour PPG, average seven-point SMPG, and body weight. Documented symptomatic hypoglycemia was approximately two-fold higher in patients treated with placebo than lixisenatide (12.7% vs 5.7%). GI TEAEs occurred more frequently in the lixisenatide- than placebo-treated group (34% vs 9.1%). Moderate renal insufficiency (estimated glomerular filtration rate between ≥30 and <60 mL/min/1.73 m2) did not negatively affect lixisenatide efficacy or safety. A greater proportion of patients treated with lixisenatide than placebo achieved composite endpoints.

CONCLUSIONS

Add-on therapy with lixisenatide in non-frail patients aged ≥70 years with T2D uncontrolled with BI is effective, safe, and well tolerated and should be considered in this population.

Authors+Show Affiliations

Scripps Whittier Diabetes Institute, La Jolla, California.Sanofi, Bridgewater, New Jersey.Sanofi, Bridgewater, New Jersey.Sanofi, Bridgewater, New Jersey.Department of Medicine, University of British Columbia, Vancouver, Canada.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31094074

Citation

Dailey, George E., et al. "Efficacy and Safety of Lixisenatide as Add-on Therapy to Basal Insulin in Older Adults With Type 2 Diabetes in the GetGoal-O Study." Journal of Diabetes, vol. 11, no. 12, 2019, pp. 971-981.
Dailey GE, Dex TA, Roberts M, et al. Efficacy and safety of lixisenatide as add-on therapy to basal insulin in older adults with type 2 diabetes in the GetGoal-O Study. J Diabetes. 2019;11(12):971-981.
Dailey, G. E., Dex, T. A., Roberts, M., Liu, M., & Meneilly, G. S. (2019). Efficacy and safety of lixisenatide as add-on therapy to basal insulin in older adults with type 2 diabetes in the GetGoal-O Study. Journal of Diabetes, 11(12), 971-981. https://doi.org/10.1111/1753-0407.12952
Dailey GE, et al. Efficacy and Safety of Lixisenatide as Add-on Therapy to Basal Insulin in Older Adults With Type 2 Diabetes in the GetGoal-O Study. J Diabetes. 2019;11(12):971-981. PubMed PMID: 31094074.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lixisenatide as add-on therapy to basal insulin in older adults with type 2 diabetes in the GetGoal-O Study. AU - Dailey,George E, AU - Dex,Terry A, AU - Roberts,Michelle, AU - Liu,Minzhi, AU - Meneilly,Graydon S, Y1 - 2019/06/26/ PY - 2019/01/04/received PY - 2019/05/09/revised PY - 2019/05/13/accepted PY - 2019/5/17/pubmed PY - 2020/4/22/medline PY - 2019/5/17/entrez KW - 2型糖尿病。 KW - lixisenatide KW - older adults KW - type 2 diabetes KW - 利西那肽 KW - 老年人 SP - 971 EP - 981 JF - Journal of diabetes JO - J Diabetes VL - 11 IS - 12 N2 - BACKGROUND: This study compared the efficacy and safety of lixisenatide with placebo as add-on therapy to basal insulin (BI) in adults aged ≥70 years with type 2 diabetes (T2D), with or without moderate renal insufficiency. METHODS: This post hoc analysis evaluated data from non-frail patients with T2D inadequately controlled on BI with or without oral antidiabetic drugs (n = 108), randomized to once-daily lixisenatide 20 μg or placebo for 24 weeks (GetGoal-O Study). The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included changes from baseline in fasting plasma glucose, 2-hour postprandial plasma glucose (PPG), average seven-point self-monitored plasma glucose (SMPG), area under the curve for SMPG, daily BI dose, body weight, proportion of patients achieving HbA1c > 0.5%, and composite endpoints. Safety outcomes included the incidence of documented symptomatic hypoglycemia (plasma glucose <60 mg/dL) and gastrointestinal treatment-emergent adverse events (TEAEs). Outcomes were also analyzed by the occurrence of moderate renal insufficiency. RESULTS: Compared with placebo, lixisenatide-treated patients had significantly greater reductions in HbA1c, 2-hour PPG, average seven-point SMPG, and body weight. Documented symptomatic hypoglycemia was approximately two-fold higher in patients treated with placebo than lixisenatide (12.7% vs 5.7%). GI TEAEs occurred more frequently in the lixisenatide- than placebo-treated group (34% vs 9.1%). Moderate renal insufficiency (estimated glomerular filtration rate between ≥30 and <60 mL/min/1.73 m2) did not negatively affect lixisenatide efficacy or safety. A greater proportion of patients treated with lixisenatide than placebo achieved composite endpoints. CONCLUSIONS: Add-on therapy with lixisenatide in non-frail patients aged ≥70 years with T2D uncontrolled with BI is effective, safe, and well tolerated and should be considered in this population. SN - 1753-0407 UR - https://www.unboundmedicine.com/medline/citation/31094074/Efficacy_and_safety_of_lixisenatide_as_add_on_therapy_to_basal_insulin_in_older_adults_with_type_2_diabetes_in_the_GetGoal_O_Study_ DB - PRIME DP - Unbound Medicine ER -