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Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial.
Diabetes Care. 2017 Apr; 40(4):485-493.DC

Abstract

OBJECTIVE

To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment.

RESEARCH DESIGN AND METHODS

In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ≥70 years were randomized to receive once-daily lixisenatide 20 μg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks. Patients at risk for malnutrition or with moderate to severe cognitive impairment were excluded. The primary end point was absolute change in HbA1c from baseline to week 24. Secondary end points included change from baseline to week 24 in 2-h postprandial plasma glucose (PPG) and body weight.

RESULTS

A total of 350 patients were randomized. HbA1c decreased substantially with lixisenatide (-0.57% [6.2 mmol/mol]) compared with placebo (+0.06% [0.7 mmol/mol]) from baseline to week 24 (P < 0.0001). Mean reduction in 2-h PPG was significantly greater with lixisenatide (-5.12 mmol/L) than with placebo (-0.07 mmol/L; P < 0.0001). A greater decrease in body weight was observed with lixisenatide (-1.47 kg) versus placebo (-0.16 kg; P < 0.0001). The safety profile of lixisenatide in this older population, including rates of nausea and vomiting, was consistent with that observed in other lixisenatide studies. Hypoglycemia was reported in 17.6% of patients with lixisenatide versus 10.3% with placebo.

CONCLUSIONS

In nonfrail older patients uncontrolled on their current antidiabetic treatment, lixisenatide was superior to placebo in HbA1c reduction and in targeting postprandial hyperglycemia, with no unexpected safety findings.

Authors+Show Affiliations

University of British Columbia, Vancouver, British Columbia, Canada meneilly@mail.ubc.ca.Sanofi, Chilly-Mazarin, France.Diabetessaar-Center, Saarlouis, Germany.Scripps Whittier Diabetes Institute, La Jolla, CA.University Hospital of Ferrol, Ferrol (Galicia), Spain.Hospital de la Ribera, Alzira, Spain.Centro de Investigación en Diabetes, Obesidad y Nutrición, Lima, Peru.BMD Consulting, Inc., Somerset, NJ.Sanofi, Chilly-Mazarin, France.Sanofi, Bridgewater, NJ.Townhead Surgery, Irvine, U.K.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28188240

Citation

Meneilly, Graydon S., et al. "Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled On Their Current Antidiabetic Treatment: the GetGoal-O Randomized Trial." Diabetes Care, vol. 40, no. 4, 2017, pp. 485-493.
Meneilly GS, Roy-Duval C, Alawi H, et al. Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial. Diabetes Care. 2017;40(4):485-493.
Meneilly, G. S., Roy-Duval, C., Alawi, H., Dailey, G., Bellido, D., Trescoli, C., Manrique Hurtado, H., Guo, H., Pilorget, V., Perfetti, R., & Simpson, H. (2017). Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial. Diabetes Care, 40(4), 485-493. https://doi.org/10.2337/dc16-2143
Meneilly GS, et al. Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled On Their Current Antidiabetic Treatment: the GetGoal-O Randomized Trial. Diabetes Care. 2017;40(4):485-493. PubMed PMID: 28188240.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial. AU - Meneilly,Graydon S, AU - Roy-Duval,Christine, AU - Alawi,Hasan, AU - Dailey,George, AU - Bellido,Diego, AU - Trescoli,Carlos, AU - Manrique Hurtado,Helard, AU - Guo,Hailing, AU - Pilorget,Valerie, AU - Perfetti,Riccardo, AU - Simpson,Hamish, AU - ,, Y1 - 2017/02/10/ PY - 2016/10/06/received PY - 2017/01/24/accepted PY - 2017/2/12/pubmed PY - 2017/10/6/medline PY - 2017/2/12/entrez SP - 485 EP - 493 JF - Diabetes care JO - Diabetes Care VL - 40 IS - 4 N2 - OBJECTIVE: To evaluate the efficacy and safety of lixisenatide versus placebo on glycemic control in older patients with type 2 diabetes uncontrolled on their current antidiabetic treatment. RESEARCH DESIGN AND METHODS: In this phase III, double-blind, randomized, placebo-controlled, two-arm, parallel-group, multicenter trial, patients aged ≥70 years were randomized to receive once-daily lixisenatide 20 μg or placebo before breakfast concomitantly with their existing antidiabetic therapy (including insulin) for 24 weeks. Patients at risk for malnutrition or with moderate to severe cognitive impairment were excluded. The primary end point was absolute change in HbA1c from baseline to week 24. Secondary end points included change from baseline to week 24 in 2-h postprandial plasma glucose (PPG) and body weight. RESULTS: A total of 350 patients were randomized. HbA1c decreased substantially with lixisenatide (-0.57% [6.2 mmol/mol]) compared with placebo (+0.06% [0.7 mmol/mol]) from baseline to week 24 (P < 0.0001). Mean reduction in 2-h PPG was significantly greater with lixisenatide (-5.12 mmol/L) than with placebo (-0.07 mmol/L; P < 0.0001). A greater decrease in body weight was observed with lixisenatide (-1.47 kg) versus placebo (-0.16 kg; P < 0.0001). The safety profile of lixisenatide in this older population, including rates of nausea and vomiting, was consistent with that observed in other lixisenatide studies. Hypoglycemia was reported in 17.6% of patients with lixisenatide versus 10.3% with placebo. CONCLUSIONS: In nonfrail older patients uncontrolled on their current antidiabetic treatment, lixisenatide was superior to placebo in HbA1c reduction and in targeting postprandial hyperglycemia, with no unexpected safety findings. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/28188240/Lixisenatide_Therapy_in_Older_Patients_With_Type_2_Diabetes_Inadequately_Controlled_on_Their_Current_Antidiabetic_Treatment:_The_GetGoal_O_Randomized_Trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=28188240 DB - PRIME DP - Unbound Medicine ER -