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Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial.
Diabetes Care. 2016 Aug; 39(8):1318-28.DC

Abstract

OBJECTIVE

To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1-3 oral antidiabetic agents (OADs).

RESEARCH DESIGN AND METHODS

Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization. Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound <0.4% [<4.4 mmol/mol]) in HbA1c reduction with lixisenatide versus glulisine once daily, and either 2a) noninferiority in HbA1c reduction for lixisenatide versus glulisine thrice daily or 2b) superiority in body weight change for lixisenatide versus glulisine thrice daily. Fasting and postprandial plasma glucose, composite efficacy/safety end points, and adverse events were also assessed.

RESULTS

Baseline characteristics were similar between arms (n = 298, diabetes and basal insulin duration of 12.2 and 3.2 years, respectively; BMI 32.2 kg/m(2)). HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met. Symptomatic hypoglycemia and body weight were lower in lixisenatide versus glulisine patients. More gastrointestinal events occurred with lixisenatide.

CONCLUSIONS

Short-acting glucagon-like peptide-1 receptor agonists as add-on to basal insulin may become a preferred treatment intensification option, attaining meaningful glycemic targets with fewer hypoglycemic events without weight gain versus basal-plus or basal-bolus in uncontrolled basal insulin-treated type 2 diabetes.

Authors+Show Affiliations

Dallas Diabetes and Endocrine Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.University of Lorraine and the Department of Diabetology, Metabolic Diseases and Nutrition, Brabois Adult Hospital, Vandœuvre-lès-Nancy, France.GWT-TUD, Study Centre Prof. Hanefeld, Dresden Technical University, Dresden, Germany.Department of Clinical and Experimental Medicine, Second University of Naples, Naples, Italy.LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.Centre in Physiopathology of Obesity and Nutrition (CIBEROBN), Carlos III Institute of Health and Hospital Virgen de la Victoria, Malaga, Spain.Sanofi, Paris, France.Sanofi, Paris, France.Sanofi, Warsaw, Poland.Sanofi, Bridgewater, NJ.Sanofi, Bridgewater, NJ.Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, U.K.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27222510

Citation

Rosenstock, Julio, et al. "Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: the GetGoal Duo-2 Trial." Diabetes Care, vol. 39, no. 8, 2016, pp. 1318-28.
Rosenstock J, Guerci B, Hanefeld M, et al. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016;39(8):1318-28.
Rosenstock, J., Guerci, B., Hanefeld, M., Gentile, S., Aronson, R., Tinahones, F. J., Roy-Duval, C., Souhami, E., Wardecki, M., Ye, J., Perfetti, R., & Heller, S. (2016). Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care, 39(8), 1318-28. https://doi.org/10.2337/dc16-0014
Rosenstock J, et al. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: the GetGoal Duo-2 Trial. Diabetes Care. 2016;39(8):1318-28. PubMed PMID: 27222510.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. AU - Rosenstock,Julio, AU - Guerci,Bruno, AU - Hanefeld,Markolf, AU - Gentile,Sandro, AU - Aronson,Ronnie, AU - Tinahones,Francisco J, AU - Roy-Duval,Christine, AU - Souhami,Elisabeth, AU - Wardecki,Marek, AU - Ye,Jenny, AU - Perfetti,Riccardo, AU - Heller,Simon, AU - ,, Y1 - 2016/05/23/ PY - 2016/01/04/received PY - 2016/04/29/accepted PY - 2016/5/26/entrez PY - 2016/5/26/pubmed PY - 2017/10/31/medline SP - 1318 EP - 28 JF - Diabetes care JO - Diabetes Care VL - 39 IS - 8 N2 - OBJECTIVE: To provide evidence-based options on how to intensify basal insulin, we explored head-to-head prandial interventions in overweight patients with type 2 diabetes inadequately controlled on basal insulin glargine with or without 1-3 oral antidiabetic agents (OADs). RESEARCH DESIGN AND METHODS: Patients were randomized to lixisenatide once daily or insulin glulisine given once or thrice daily, added to glargine, with or without metformin, if HbA1c remained ≥7 to ≤9% (≥53 to ≤75 mmol/mol) after 12 weeks of glargine optimization with OADs other than metformin stopped at the start of optimization. Coprimary end points at 26 weeks were 1) noninferiority (95% CI upper bound <0.4% [<4.4 mmol/mol]) in HbA1c reduction with lixisenatide versus glulisine once daily, and either 2a) noninferiority in HbA1c reduction for lixisenatide versus glulisine thrice daily or 2b) superiority in body weight change for lixisenatide versus glulisine thrice daily. Fasting and postprandial plasma glucose, composite efficacy/safety end points, and adverse events were also assessed. RESULTS: Baseline characteristics were similar between arms (n = 298, diabetes and basal insulin duration of 12.2 and 3.2 years, respectively; BMI 32.2 kg/m(2)). HbA1c improved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and glulisine once daily and thrice daily, respectively; all coprimary end points were met. Symptomatic hypoglycemia and body weight were lower in lixisenatide versus glulisine patients. More gastrointestinal events occurred with lixisenatide. CONCLUSIONS: Short-acting glucagon-like peptide-1 receptor agonists as add-on to basal insulin may become a preferred treatment intensification option, attaining meaningful glycemic targets with fewer hypoglycemic events without weight gain versus basal-plus or basal-bolus in uncontrolled basal insulin-treated type 2 diabetes. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/27222510/Prandial_Options_to_Advance_Basal_Insulin_Glargine_Therapy:_Testing_Lixisenatide_Plus_Basal_Insulin_Versus_Insulin_Glulisine_Either_as_Basal_Plus_or_Basal_Bolus_in_Type_2_Diabetes:_The_GetGoal_Duo_2_Trial_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=27222510 DB - PRIME DP - Unbound Medicine ER -