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Prandial Options to Advance Basal Insulin Glargine Therapy

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Prandial Options to Advance Basal Insulin Glargine Therapy 1318 Diabetes Care Volume 39, August 2016 Julio Rosenstock,1 Bruno Guerci,2 Prandial Options to Advance Basal Markolf Hanefeld,3 Sandro Gentile,4 Ronnie Aronson,5 Francisco J. Tinahones,6 Insulin Glargine Therapy: Testing Christine Roy-Duval,7 Elisabeth Souhami,7 Marek Wardecki,8 Jenny Ye,9 Lixisenatide Plus Basal Insulin Riccardo Perfetti,9 and Simon Heller,10 on behalf of the GetGoal Duo-2 Trial Versus Insulin Glulisine Either as Investigators Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial Diabetes Care 2016;39:1318–1328 | DOI: 10.2337/dc16-0014 CLIN CARE/EDUCATION/NUTRITION/PSYCHOSOCIAL 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 antidi- 1Dallas Diabetes and Endocrine Center at Medi- abetic agents (OADs). cal City, Dallas, TX 2University of Lorraine and the Department of RESEARCH DESIGN AND METHODS Diabetology, Metabolic Diseases and Nutrition, Brabois Adult Hospital, Vandœuvre-les-Nancy,` Patients were randomized to lixisenatide once daily or insulin glulisine given once France 3 or thrice daily, added to glargine, with or without metformin, if HbA1c remained GWT-TUD, Study Centre Prof. Hanefeld, Dres- ‡7to£9% (‡53 to £75 mmol/mol) after 12 weeks of glargine optimization with den Technical University, Dresden, Germany 4Department of Clinical and Experimental Med- OADs other than metformin stopped at the start of optimization. Coprimary end points icine, Second University of Naples, Naples, Italy at 26 weeks were 1) noninferiority (95% CI upper bound <0.4% [<4.4 mmol/mol]) 5LMC Diabetes & Endocrinology, Toronto, On- in HbA reduction with lixisenatide versus glulisine once daily, and either 2a) non- tario, Canada 1c 6 inferiority in HbA reduction for lixisenatide versus glulisine thrice daily or 2b)supe- Centre in Physiopathology of Obesity and Nutri- 1c tion (CIBEROBN), Carlos III Institute of Health riority in body weight change for lixisenatide versus glulisine thrice daily. Fasting and Hospital Virgen de la Victoria, Malaga, Spain and postprandial plasma glucose, composite efficacy/safety end points, and ad- 7Sanofi, Paris, France verse events were also assessed. 8Sanofi, Warsaw, Poland 9Sanofi, Bridgewater, NJ 10 RESULTS Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, Baseline characteristics were similar between arms (n = 298, diabetes and basal U.K. 2 insulin duration of 12.2 and 3.2 years, respectively; BMI 32.2 kg/m ). HbA1c im- Corresponding author: Julio Rosenstock, proved from 8.5% to 7.9% (69 to 63 mmol/mol) with glargine optimization and [email protected]. further to 7.2%, 7.2%, and 7.0% (55, 55, and 53 mmol/mol) with lixisenatide and Received 4 January 2016 and accepted 29 April glulisine once daily and thrice daily, respectively; all coprimary end points were 2016. met. Symptomatic hypoglycemia and body weight were lower in lixisenatide Clinical trial reg. no. NCT01768559, clinicaltrials versus glulisine patients. More gastrointestinal events occurred with lixisenatide. .gov. This article contains Supplementary Data online CONCLUSIONS at http://care.diabetesjournals.org/lookup/ Short-acting glucagon-like peptide-1 receptor agonists as add-on to basal insulin suppl/doi:10.2337/dc16-0014/-/DC1. may become a preferred treatment intensification option, attaining meaningful © 2016 by the American Diabetes Association. Readers may use this article as long as the work is glycemic targets with fewer hypoglycemic events without weight gain versus properly cited, the use is educational and not for basal-plus or basal-bolus in uncontrolled basal insulin-treated type 2 diabetes. profit, and the work is not altered. care.diabetesjournals.org Rosenstock and Associates 1319 The conventional recommendation in The present 26-week trial (GetGoal were eligible for screening. Patients type 2 diabetes inadequately controlled Duo-2) took the above findings further were on basal insulin for at least 6 months with basal insulin plus oral antidiabetic and evaluated head-to-head in a ran- at screening (stable dose $20 units/day agents (OADs) has been the addition of a domized fashion the efficacy and safety for $2 months before screening), alone prandial insulin as a single injection with of lixisenatide 20 mg once daily versus or combined with stable doses of 1–3 the main meal (basal-plus) or progres- insulin glulisine once daily (basal-plus) OADs (metformin [$1.5 mg/day or max- sively covering all meals (basal-bolus) (1). or thrice daily (basal-bolus) for intensi- imum tolerated dose], a DPP-4 inhibitor, Evidence from a randomized head-to- fication of optimized insulin glargine, an SU, or a glinide). Patients receiving head trial comparing initiation of insulin with or without metformin, in uncon- basal insulin alone or with metformin glargine plus insulin glulisine as basal-plus trolled patients on basal insulin with or hadtohaveHbA1c 7.5–10.0% (58– or basal-bolus versus twice-daily pre- without OADs. It is hoped that this trial 86 mmol/mol) at screening. Patients re- mixed insulin demonstrated that these will provide evidence-based data to aid ceiving basal insulin plus an SU and/or regimens can achieve substantial and in the clinical decision-making process a DPP-4 inhibitor and/or a glinide comparable reductions in HbA1c to almost for individualization of basal insulin- hadtohaveHbA1c 7.0–10.0% (53– 7% (53 mmol/mol) over 60 weeks (2). based therapy in patients with type 2 86 mmol/mol) at screening. Because all However, hypoglycemia and weight gain diabetes when intensification of treat- OADs other than metformin were dis- occurred in each prandial insulin injection ment is required. continued at the start of the run-in group. Indeed, unacceptable weight gain phase, the two different HbA1c thresh- and hypoglycemia are pressing issues in RESEARCH DESIGN AND METHODS olds were necessary to compensate for the management of type 2 diabetes, and the subsequent expected increase in Trial Design hypoglycemic risk increases as type 2 di- HbA in the latter group. GetGoal Duo-2 was a randomized, open- 1c abetes advances, impeding attainment of Exclusion criteria included a clinically label, active comparator trial with three glycemic targets (3). relevant history of gastrointestinal dis- parallel arms conducted at 199 centers in The recently updated American Diabe- ease or a history of unexplained/chronic 18 countries. The study was initiated in tes Association/European Association for pancreatitis. Patients were excluded if January 2013 and completed in Decem- the Study of Diabetes treatment guide- they had alanine/aspartate aminotrans- ber 2014. Adults with type 2 diabetes un- lines have largely reiterated this prandial ferase, amylase, or lipase levels more controlled on $6 months’ basal insulin, insulin recommendation but also pro- than three times the upper limit of normal with or without 1–3 OADs, were eligible posed the option of adding a glucagon- or calcitonin levels .20 pg/mL. to enter a 12-week run-in period. On run- like peptide-1 receptor agonist (GLP-1 in entry, OADs other than metformin (di- RA) to basal insulin (4). Although these peptidyl peptidase-4 [DPP-4] inhibitors, Run-in Phase updated guidelines emphasize the impor- During run-in, insulin glargine was intro- sulfonylureas [SU], and glinides) were dis- tance of individualizing treatment and duced (for patients previously on a differ- continued, and insulin glargine was opti- go some way toward revising the exist- ent basal insulin) or continued as part of a mally titrated. After the run-in phase, if ing treatment paradigm, they are not once-daily regimen, at breakfast or at the HbA remained between $7and#9% evidence-based, because the three in- 1c evening meal, as determined at the start ($53 and #75 mmol/mol) and mean jectable options (GLP-1 RA, basal insu- of the run-in period, and titrated every fasting plasma glucose (FPG) was #140 lin, and prandial insulin) have not been 3 days to achieve fasting self-monitored mg/dL (#7.8 mmol/L), patients were ran- compared directly in a single properly plasma glucose (SMPG) between 80 and domized 1:1:1 (by interactive voice or controlled study to address the multiple 100 mg/dL (4.4 and 5.6 mmol/L) while Web response system), and stratified by issues affecting outcomes (5). avoiding hypoglycemia (11). baseline HbA (,8or$8% [,64 or .64 GLP-1 RAs improve glycemia without 1c mmol/mol]) and metformin use, to re- substantially increasing hypoglycemic ceive subcutaneous lixisenatide once Randomized Treatment Phase risk and without weight gain. Lixisenatide Insulin glargine doses were adjusted daily or insulin glulisine once or thrice (Lyxumia; Sanofi, Paris, France) is a once- weekly to maintain fasting daily SMPG daily as add-on therapy to insulin glargine daily prandial GLP-1 RA with robust post- between 80 and 100 mg/dL (4.4 and 5.6 with or without metformin. The trial com- prandial glucose (PPG)-lowering effect, mmol/L) except during the 4 weeks after prised three periods (Supplementary predominantly via delayed gastric empty- randomization when a stable insulin Fig. 1): 1) a screening phase of up to ing and glucose-dependent reductions in dose was maintained. Timing of insulin 2 weeks, followed by a 12-week run-in glucagon release (6–9). glargine injections was established dur- phase; 2) 26 weeks of open-label, random- The GetGoal Duo-1 trial was the first ing the run-in, whereas timing of the ized treatment; and 3) 3 days of follow-up. study to assess the efficacy of lixisenatide once-daily prandial intervention was All patients signed an informed consent in combination with optimally titrated based on the main meal during the week form. The trial protocol complied with basal insulin in patients with type 2 diabe- before randomization.
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