Use of glucagon-like peptide-1 receptor agonists among individuals on basal insulin requiring treatment intensification.

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Term Occurence Count Dictionary
Albiglutide 1 endocrinologydiseasesdrugs
Exenatide 4 endocrinologydiseasesdrugs
Insulin 24 endocrinologydiseasesdrugs
Liraglutide 9 endocrinologydiseasesdrugs
dulaglutide 2 endocrinologydiseasesdrugs
metformin 23 endocrinologydiseasesdrugs
pioglitazone 5 endocrinologydiseasesdrugs

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Select Drug Character Offset Drug Term Instance
Albiglutide 17167 Group) 48Insulin glargine, prior metformin, pioglitazone and α‐glucosidase inhibitors maintained Albiglutide (once weekly); N = 285–9 (–0.8)–0.7*Number of hypoglycaemic events (any kind): 70 (24.6%)11.26.713.0NRPrandial
Exenatide 12868 weeks): 0.0% (13–24 weeks): 0.19% NRBuse et al. 2011 35Insulin glargine, metformin, and/or pioglitazone Exenatide twice daily; N = 138–19 (–1.7)†–1.8‡Hypoglycaemic events per participant per year: 1.441‡18‡18‡10‡Placebo;
Exenatide 13143 events per participant per year: 1.28482Diamant et al. 2014 (4B Study) 27Insulin glargine, metformin Exenatide twice daily; N = 315–12 (–1.1)–2.5*Major events: 3; minor events: 332; nocturnal confirmed: 232;
Exenatide 13593 et al. 2016 (4B Study; subgroup analysis of Latin American patients) 36Insulin glargine, metformin Exenatide twice daily; N = 48–10 (–0.9)–0.1*Major + minor events: 40; major events: 0; nocturnal: 26; daytime:
Exenatide 25667 lixisenatide.The different GLP‐1RAs can be further subcategorized by their duration of exposure. Exenatide twice daily and lixisenatide (once daily), two short‐acting GLP‐1RAs, are typically dosed before
Insulin 11978 in weight, kgReported hypoglycaemiaFrequency of GI AEs, % of participantsNVDCDavidson et al. 2011 10 Insulin glargine, two or three oral glucose‐lowering medications (sulfonylureas, metformin, thiazolidinediones)Prandial
Insulin 12509 hypoglycaemia: 18*NRSiegmund et al. 2017 11Oral glucose‐lowering medications, basal insulin glargine Insulin glargine ± rapid‐acting insulin analogue;N = 1684 –8 (–0.8)–0.9* Severe hypoglycaemia (1–12
Insulin 12820 (–0.9)–0.5 Severe hypoglycaemia (1–12 weeks): 0.0% (13–24 weeks): 0.19% NRBuse et al. 2011 35 Insulin glargine, metformin, and/or pioglitazoneExenatide twice daily; N = 138–19 (–1.7)†–1.8‡Hypoglycaemic
Insulin 13116 (–1.0)+1.0Hypoglycaemic events per participant per year: 1.28482Diamant et al. 2014 (4B Study) 27 Insulin glargine, metforminExenatide twice daily; N = 315–12 (–1.1)–2.5*Major events: 3; minor events:
Insulin 13565 584†1.61.05.1NRde Lapertosa et al. 2016 (4B Study; subgroup analysis of Latin American patients) 36 Insulin glargine, metformin Exenatide twice daily; N = 48–10 (–0.9)–0.1*Major + minor events: 40; major
Insulin 13917 253; major events: 6; nocturnal: 98; daytime: 1551.71.78.6NRRiddle et al. 2013 (GetGoal Duo‐1) 37 Insulin glargine, prior metformin ± thiazolidinediones maintainedLixisenatide (once daily); N = 223–8 (–0.7)‡+0.3‡Confirmed
Insulin 14982 patient38.9NRPlacebo (once daily); N = 18–1.0 (–0.1)–0.6NR11.1NRMathieu et al. 2014 (BEGIN: VICTOZA ADD‐ON) 41 Insulin degludec, metforminLiraglutide (once daily); N = 88–8 (–0.7)*–2.8†Episodes per PYE: 1.00†20.75.710.3NRInsulin
Insulin 15102 metforminLiraglutide (once daily); N = 88–8 (–0.7)*–2.8†Episodes per PYE: 1.00†20.75.710.3NR Insulin aspart (once daily); N = 89–4 (–0.4)+0.9Episodes per PYE: 8.15NRNRNRNRAhmann et al. 2015 42Insulin
Insulin 15206 1.00†20.75.710.3NRInsulin aspart (once daily); N = 89–4 (–0.4)+0.9Episodes per PYE: 8.15NRNRNRNRAhmann et al. 2015 42 Insulin glargine or insulin detemir ± metforminLiraglutide (once daily); N = 226–14.2 (–1.3)‡–3.5‡Confirmed
Insulin 15538 (–0.1)–0.4Confirmed hypoglycaemic episodes: 82 (83 events/100 PYE)3.10.90.9NRde Wit et al. 2014 (ELEGANT) 43 Insulin (basal only, basal bolus, biphasic, pump) ± metformin ± sulfonylureasLiraglutide (once daily); N =
Insulin 15865 (+0.01)+0.9 Grade 1: 33.3%; Grade 2: 8.3% 12.54.225.08.3de Wit et al. 2016 (ELEGANT 52‐week results) 44 Insulin (basal only, basal bolus, biphasic, pump) ± metformin ± sulfonylureasLiraglutide (once daily); N =
Insulin 16167 2)48.925.551.151.1Background insulin → liraglutide (once daily); N = 21–7 (–0.7)–4.3Seino et al. 2016 45 Insulin (basal, premixed, or basal bolus)Liraglutide (once daily); N = 127–19 (–1.7)‡–0.3Confirmed hypoglycaemia:
Insulin 16423 daily); N = 130–5 (–0.4)+0.5Confirmed hypoglycaemia: 27.7%5.4NR3.11.5Vanderheiden et al. 2016 47 Insulin (basal, premixed, or basal bolus)Liraglutide (once daily); N = 35–10 (–0.9)‡–2.0‡Any hypoglycaemic
Insulin 16699 daily); N = 360 (0.0)+0.4Any hypoglycaemic events/person‐month of exposure: 0.93 NRLi et al. 2012 46 Insulin (glargine, NPG, premixed) ± oral medications (including sulfonylureas, thiazolidinediones, α‐glucosidase
Insulin 16941 metformin)Liraglutide (once daily); N = 42–21 (–1.9)–5.6 Severe: 0 participants Minor: 11.9%†NR Insulin dose increase; N = 42–19 (–1.8)+2.0 Severe: 2 participants Minor: 31.0% NRRosenstock et al. 2014
Insulin 17077 (–1.8)+2.0 Severe: 2 participants Minor: 31.0% NRRosenstock et al. 2014 (Harmony 6 Study Group) 48 Insulin glargine, prior metformin, pioglitazone and α‐glucosidase inhibitors maintainedAlbiglutide (once
Insulin 17576 pioglitazoneIDegLira (once daily); N = 834–21 (–1.9)*,†–0.5*,†Confirmed hypoglycaemia: 32%*,†948NR Insulin degludec (once daily); N = 414–15 (–1.4)+1.6Confirmed hypoglycaemia: 39%415NRLiraglutide (once daily);
Insulin 17931 (once daily); N = 833–20 (–1.8)*,†–0.4*,†Confirmed hypoglycaemic events/100 PYE: 176.7*,†NR Insulin degludec (once daily); N = 413–15 (–1.4)+2.3Confirmed hypoglycaemic events/100 PYE: 279.1NRLiraglutide
Insulin 18264 58MetforminIDegLira (once daily); N = 199–21 (–1.9)*–2.7*Confirmed hypoglycaemia: 24%6.5NR6.5NR Insulin degludec (once daily); N = 199–10 (–0.9)0.0Confirmed hypoglycaemia: 25%3.5NR3.5NRLingvay et al.
Insulin 18498 59MetforminIDegLira (once daily); N = 278–20 (–1.8)*–1.4*Confirmed hypoglycaemic events/PYE: 2.23*9.4NR Insulin glargine (once daily); N = 279–14 (–1.1)+1.8Confirmed hypoglycaemic events/PYE: 5.051.1NRBillings
Insulin 18721 (DUAL VII) 60IDegLira (once daily); N = 252–16 (–1.5)–0.9Hypoglycaemic events/PYE: 1.1NRNRNRNR Insulin glargine (once daily) + insulin aspart (prandial); N = 254–16 (–1.5)+2.6Hypoglycaemic events/PYE:
Insulin 19015 daily); N = 161–20 (–1.8)*–1.0*Documented symptomatic hypoglycaemic events: 35 (21.7%)7.52.53.11.9 Insulin glargine (once daily); N = 162–18 (–1.6)+0.5Documented symptomatic hypoglycaemic events: 37 (22.8%)0.00.63.70.0Aroda
Insulin 19310 N = 367–14 (–1.1)*–0.7*Documented symptomatic hypoglycaemia: 40% (3.03 events/PYE)10.43.64.4NR Insulin glargine (once daily); N = 369–7 (–0.6)+0.7Documented symptomatic hypoglycaemia: 42.5% (4.22 events/PYE)0.50.52.7NRRosenstock
Insulin 19618 469–18 (–1.6)*,†–0.3*Documented symptomatic hypoglycaemia: 25.6% (1.4 events/PYE)9.63.29.0NR Insulin glargine (once daily); N = 467–14 (–1.3)+1.1Documented symptomatic hypoglycaemia: 23.6% (1.2 events/PYE)3.61.54.3NRLixisenatide
Liraglutide 15009 18–1.0 (–0.1)–0.6NR11.1NRMathieu et al. 2014 (BEGIN: VICTOZA ADD‐ON) 41Insulin degludec, metformin Liraglutide (once daily); N = 88–8 (–0.7)*–2.8†Episodes per PYE: 1.00†20.75.710.3NRInsulin aspart (once
Liraglutide 15254 (–0.4)+0.9Episodes per PYE: 8.15NRNRNRNRAhmann et al. 2015 42Insulin glargine or insulin detemir ± metformin Liraglutide (once daily); N = 226–14.2 (–1.3)‡–3.5‡Confirmed hypoglycaemic episodes: 127 (126 events/100
Liraglutide 15617 et al. 2014 (ELEGANT) 43Insulin (basal only, basal bolus, biphasic, pump) ± metformin ± sulfonylureas Liraglutide (once daily); N = 26–8 (–0.8)*–4.5* Grade 1: 50.0%; Grade 2: 15.4% 42.3*23.138.5*53.8Background
Liraglutide 15944 52‐week results) 44Insulin (basal only, basal bolus, biphasic, pump) ± metformin ± sulfonylureas Liraglutide (once daily); N = 25–7 (–0.6)+1.1Minor hypoglycaemic events/PYE: 2.9 (grade 1) and 0.9 (grade 2)48.925.551.151.1Background
Liraglutide 16208 (once daily); N = 21–7 (–0.7)–4.3Seino et al. 2016 45Insulin (basal, premixed, or basal bolus) Liraglutide (once daily); N = 127–19 (–1.7)‡–0.3Confirmed hypoglycaemia: 33.1%11.0NR11.811.8Placebo (once
Liraglutide 16464 hypoglycaemia: 27.7%5.4NR3.11.5Vanderheiden et al. 2016 47Insulin (basal, premixed, or basal bolus) Liraglutide (once daily); N = 35–10 (–0.9)‡–2.0‡Any hypoglycaemic events/person‐month of exposure: 1.44
Liraglutide 16848 medications (including sulfonylureas, thiazolidinediones, α‐glucosidase inhibitors, glinides, metformin) Liraglutide (once daily); N = 42–21 (–1.9)–5.6 Severe: 0 participants Minor: 11.9%†NRInsulin dose increase;
Liraglutide 17665 32%*,†948NRInsulin degludec (once daily); N = 414–15 (–1.4)+1.6Confirmed hypoglycaemia: 39%415NR Liraglutide (once daily); N = 415–14 (–1.3)–0.3Confirmed hypoglycaemia: 7%20813NRGough et al. 2015 (DUAL‐I
Liraglutide 18034 176.7*,†NRInsulin degludec (once daily); N = 413–15 (–1.4)+2.3Confirmed hypoglycaemic events/100 PYE: 279.1NR Liraglutide (once daily); N = 414–13 (–1.2)–3.0Confirmed hypoglycaemic events/100 PYE: 19.1NRBuse et al.
dulaglutide 25552 in both the USA and Europe: exenatide twice daily, exenatide once weekly, liraglutide, albiglutide, dulaglutide and lixisenatide.The different GLP‐1RAs can be further subcategorized by their duration of exposure.
dulaglutide 26339 measures. In contrast, for the long‐acting GLP‐1RAs exenatide once weekly, liraglutide, albiglutide and dulaglutide , effects on gastric emptying are not as strong as their short‐acting counterparts 31 or decline over
metformin 7329 individual's characteristics 5. If initial lifestyle modifications are ineffective, oral monotherapy with metformin is the recommended first‐line therapy for most people 1. If HbA1c concentration is still above target
metformin 7700 of dual therapy.Injectable therapy with either basal insulin or a GLP‐1RA may be initiated after metformin as second‐ or third‐line treatment 1, 3. In the DURATION‐3 study, which compared the GLP‐1RA
metformin 12061 participantsNVDCDavidson et al. 2011 10Insulin glargine, two or three oral glucose‐lowering medications (sulfonylureas, metformin , thiazolidinediones)Prandial insulin glulisine (once daily); N = 115–5 (–0.4)+3.8Participants with
metformin 12838 (–0.9)–0.5 Severe hypoglycaemia (1–12 weeks): 0.0% (13–24 weeks): 0.19% NRBuse et al. 2011 35Insulin glargine, metformin , and/or pioglitazoneExenatide twice daily; N = 138–19 (–1.7)†–1.8‡Hypoglycaemic events per
metformin 13134 (–1.0)+1.0Hypoglycaemic events per participant per year: 1.28482Diamant et al. 2014 (4B Study) 27Insulin glargine, metformin Exenatide twice daily; N = 315–12 (–1.1)–2.5*Major events: 3; minor events: 332; nocturnal confirmed:
metformin 13583 Lapertosa et al. 2016 (4B Study; subgroup analysis of Latin American patients) 36Insulin glargine, metformin Exenatide twice daily; N = 48–10 (–0.9)–0.1*Major + minor events: 40; major events: 0; nocturnal:
metformin 13941 nocturnal: 98; daytime: 1551.71.78.6NRRiddle et al. 2013 (GetGoal Duo‐1) 37Insulin glargine, prior metformin ± thiazolidinediones maintainedLixisenatide (once daily); N = 223–8 (–0.7)‡+0.3‡Confirmed hypoglycaemia:
metformin 14533 (+0.1)+0.1Symptomatic hypoglycaemia: 23.6%4.51.92.52.5Riddle et al. 2013 (GetGoal‐L) 39Basal insulin ± metformin Lixisenatide (once daily); N = 328–8 (–0.7)‡–1.8‡Symptomatic hypoglycaemia: 26.5%26.28.27.3NRPlacebo
metformin 14775 167–5 (–0.4)–0.5Symptomatic hypoglycaemia: 21.0%8.40.65.4NRFarngren et al. 2016 40Basal insulin, metformin Lixisenatide (once daily); N = 18–5.8 (–0.5)–1.7‡Mild hypoglycaemia: 1 patient38.9NRPlacebo (once
metformin 15000 = 18–1.0 (–0.1)–0.6NR11.1NRMathieu et al. 2014 (BEGIN: VICTOZA ADD‐ON) 41Insulin degludec, metformin Liraglutide (once daily); N = 88–8 (–0.7)*–2.8†Episodes per PYE: 1.00†20.75.710.3NRInsulin
metformin 15245 (–0.4)+0.9Episodes per PYE: 8.15NRNRNRNRAhmann et al. 2015 42Insulin glargine or insulin detemir ± metformin Liraglutide (once daily); N = 226–14.2 (–1.3)‡–3.5‡Confirmed hypoglycaemic episodes: 127 (126
metformin 15591 PYE)3.10.90.9NRde Wit et al. 2014 (ELEGANT) 43Insulin (basal only, basal bolus, biphasic, pump) ± metformin ± sulfonylureasLiraglutide (once daily); N = 26–8 (–0.8)*–4.5* Grade 1: 50.0%; Grade 2: 15.4% 42.3*23.138.5*53.8Background
metformin 15918 Wit et al. 2016 (ELEGANT 52‐week results) 44Insulin (basal only, basal bolus, biphasic, pump) ± metformin ± sulfonylureasLiraglutide (once daily); N = 25–7 (–0.6)+1.1Minor hypoglycaemic events/PYE: 2.9
metformin 16838 oral medications (including sulfonylureas, thiazolidinediones, α‐glucosidase inhibitors, glinides, metformin )Liraglutide (once daily); N = 42–21 (–1.9)–5.6 Severe: 0 participants Minor: 11.9%†NRInsulin
metformin 17101 participants Minor: 31.0% NRRosenstock et al. 2014 (Harmony 6 Study Group) 48Insulin glargine, prior metformin , pioglitazone and α‐glucosidase inhibitors maintainedAlbiglutide (once weekly); N = 285–9 (–0.8)–0.7*Number
metformin 29287 either exenatide twice daily or prandial insulin lispro, both added to titrated insulin glargine and metformin , for 30 weeks. At endpoint, HbA1c was reduced in both groups and exenatide twice daily was found to
metformin 32000 treatment intensification in individuals with an HbA1c of 61 mmol/mol (7.7%) despite basal insulin and metformin treatment, 6 weeks of lixisenatide treatment resulted in reductions in HbA1c and body weight vs placebo
metformin 33042 effects of once‐daily insulin aspart with once‐daily liraglutide, added to basal insulin degludec and metformin , among participants with HbA1c ≥53 mmol/mol (≥7.0%) despite treatment with basal insulin 41. At
metformin 33725 26‐week study that compared liraglutide with placebo, both added to basal insulin with or without metformin , found that both HbA1c and body weight decreased significantly (P < 0.0001) more with liraglutide than
metformin 38966 administered separately among participants (n = 1170) with Type 2 diabetes who were uncontrolled on metformin with or without a second oral glucose‐lowering agent (Table 1) 52. After 30 weeks, individuals receiving
metformin 40993 liraglutide 3.6 mg/ml) with its components, insulin degludec (100 U/ml) and liraglutide (6 mg/ml), plus metformin and pioglitazone at pre‐trial doses in participants with Type 2 diabetes (Table 1) 56. Compared with
metformin 42272 insulin glargine titration among individuals with Type 2 diabetes uncontrolled on insulin glargine plus metformin , 26 weeks of treatment with IDegLira was non‐inferior to insulin glargine uptitration regarding effects
metformin 43043 for non‐inferiority) among individuals with inadequate glycaemic control on insulin glargine plus metformin (Table 1) 60. Similar proportions of participants achieved HbA1c goals of <53 mmol/mol (<7.0%) and
pioglitazone 12856 (1–12 weeks): 0.0% (13–24 weeks): 0.19% NRBuse et al. 2011 35Insulin glargine, metformin, and/or pioglitazone Exenatide twice daily; N = 138–19 (–1.7)†–1.8‡Hypoglycaemic events per participant per year:
pioglitazone 17112 participants Minor: 31.0% NRRosenstock et al. 2014 (Harmony 6 Study Group) 48Insulin glargine, prior metformin, pioglitazone and α‐glucosidase inhibitors maintainedAlbiglutide (once weekly); N = 285–9 (–0.8)–0.7*Number
pioglitazone 17466 hypoglycaemic events (any kind): 107 (38.1%)1.41.44.3NRGough et al. 2014 (DUAL‐I) 56Metformin ± pioglitazone IDegLira (once daily); N = 834–21 (–1.9)*,†–0.5*,†Confirmed hypoglycaemia: 32%*,†948NRInsulin
pioglitazone 17807 (–1.3)–0.3Confirmed hypoglycaemia: 7%20813NRGough et al. 2015 (DUAL‐I extension) 57Metformin ± pioglitazone IDegLira (once daily); N = 833–20 (–1.8)*,†–0.4*,†Confirmed hypoglycaemic events/100 PYE: 176.7*,†NRInsulin
pioglitazone 41007 mg/ml) with its components, insulin degludec (100 U/ml) and liraglutide (6 mg/ml), plus metformin and pioglitazone at pre‐trial doses in participants with Type 2 diabetes (Table 1) 56. Compared with liraglutide,
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