Abstract
Here, the new aspects of diabetes methodology will be reviewed with reference to injection therapy, using analog insulins, GLP1 agonists (incretin mimetics), and the coformulation of incretin mimetics and insulins in the same solution. The options of diabetes therapy with sensor-augmented insulin pumps and the clinical pharmacology of bihormonal insulin pumps dispensing insulin and glucagon as required will be presented (bionic pumps). The specific aspect of advanced insulin pump therapy is the use of algorithms which control the insulin infusion rate and initiate shutdown of insulin infusion when impending hypoglycemia is detected. Bionic pumps (bihormonal) may also provide a stable glucagon solution for fine-tuning of glucose regulation and emergency release, in case of hypoglycemia developing rapidly or inadvertently, in particular during sleep at night time.
References and Further Reading
Abdul-Ghani MA et al (2015) Renal sodium-glucose cotransporter inhibition in the management of type 2 diabetes mellitus. Am J Physiol Renal Physiol 309(11):F889–F900
Abdul-Ghani M, DeFronzo RA, Del Prato S et al (2017) Cardiovascular disease and type 2 diabetes: has the dawn of a new era arrived? Diabetes Care 40(7):813–820
ADA (2019) American Diabetes Association, Standards of Care 2019. https://professional.diabetes.org/content-page/practice-guidelines-resources
Ahern JA, Boland EA, Doane R et al (2002) Insulin pump therapy in pediatrics: a therapeutic alternative to safely lower HbA1c levels across all age groups. Pediatr Diabetes 3(1):10–15
Ahmann AJ, Rodbard HW, Rosenstock J et al (2014) Efficacy and safety of liraglutide vs. placebo when added to basal insulin analogs in patients with type 2 diabetes (LIRAADD2BASAL). Diabetes 63:A87
Ahren B (2011) The future of incretin-based therapy: novel avenues – novel targets. Diabetes Obes Metab 13:158–166
Alatorre C, Fernández Landó L, Yu M et al (2017) Treatment patterns in patients with type 2 diabetes mellitus treated with glucagon-like peptide-1 receptor agonists: higher adherence and persistence with dulaglutide compared with once-weekly exenatide and liraglutide. Diabetes Obes Metab 19(7):953–961
American Diabetes Association (2018) 3. Comprehensive medical evaluation and assessment of comorbidities: Standards of Medical Care in Diabetes-2018 Diabetes Care 41(Suppl 1):S28–S37
An J, Le QA, Dang T (2019) Association between different types of comorbidity and disease burden in patients with diabetes. J Diabetes 11(1):65–74
Anhalt H, Bohannon NJ (2010) Insulin patch pumps: their development and future in closed-loop systems. Diabetes Technol Ther 12(Suppl 1):S51–S58
Asche C, LaFleur J, Conner C (2011) A review of diabetes treatment adherence and the association with clinical and economic outcomes. Clin Ther 33(1):74–109
Aye T, Block J, Buckingham B (2010) Toward closing the loop: an update on insulin pumps and continuous glucose monitoring systems. Endocrinol Metab Clin N Am 39(3):609–624
Bahtiyar G, Pujals-Kury J, Sacerdote A (2018) Cardiovascular effects of different GLP-1 receptor agonists in patients with type 2 diabetes. Curr Diab Rep 18(10):92
Bailey T, Zisser H, Chang A (2009) New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. Diabetes Technol Ther 11(12):749–755
Banerji MA, Dunn JD (2013) Impact of glycemic control on healthcare resource utilization and costs of type 2 diabetes: current and future pharmacologic approaches to improving outcomes. Am Health Drug Benefits 6(7):382–392
Barnett AH (2013) Complementing insulin therapy to achieve glycemic control. Adv Ther 30(6):557–576
Becker HA (2011) Pharmacodynamic evaluation: diabetes methodologies. In: Vogel HG et al (eds) Drug discovery and evaluation: methods in clinical pharmacology. Springer, Berlin/Heidelberg, pp 457–481
Bergenstal RM, Tamborlane WV, Ahmann A, et al (2010) Effectiveness of sensor-augmented insulin pump therapy in type 1 diabetes
Best JH, Boye KS, Rubin RR et al (2009) Improved treatment satisfaction and weight-related quality of life with exenatide once weekly or twice daily. Diabet Med 26:722–728
Bethel MA, Patel RA, Merrill P et al (2018) Cardiovascular outcomes with glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a meta-analysis. Lancet Diabetes Endocrinol 6(2):105–113
Billings LK, Doshi A, Gouet D et al (2018) Efficacy and safety of IDegLira versus basal-bolus insulin therapy in patients with type 2 diabetes uncontrolled on metformin and basal insulin: the DUAL VII randomized clinical trial. Diabetes Care 41:1009–1016
Blak BT, Smith HT, Hards M et al (2012) Optimization of insulin therapy in patients with type 2 diabetes mellitus: beyond basal insulin. Diabet Med 29:e13–e20
Boyle JG, Livingstone R, Petrie JR (2018) Cardiovascular benefits of GLP-1 agonists in type 2 diabetes: a comparative review. Clin Sci (Lond) 132(15):1699–1709
Boyne MS, Silver DM, Kaplan J et al (2003) Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor. Diabetes 52(11):2790–2794
Briscoe VJ, Davis SN (2006) Hypoglycemia in type 1 and type 2 diabetes: physiology, pathophysiology, and management. Clin Diabetes 24:115–121
Buckingham WDM, Lecher T et al (2008) Duration of nocturnal hypoglycemia before seizures. Diabetes Care 31(11):2110–2112
Buckingham BA, Forlenza GP, Pinsker JE et al (2018) Safety and feasibility of the OmniPod hybrid closed-loop system in adult, adolescent, and pediatric patients with type 1 diabetes using a personalized model predictive control algorithm. Diabetes Technol Ther 20(4):257–262
Buse JB, Rosenstock J, Sesti G et al (2009) Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 374:39–47
Buse JB, Sesti G, Schmidt SE et al (2010) Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care 33:1300–1303
Buse JB, Drucker DJ, Taylor KL, Kim T et al (2010b) DURATION-1 Study Group. DURATION-1: exenatide once weekly produces sustained glycemic control and weight loss over 52 weeks. Diabetes Care 33(6):1255–1261
Buse JB, Sesti G, Schmidt SE et al (2010c) Switching to once-daily liraglutide from twice-daily exenatide further improves glycemic control in patients with type 2 diabetes using oral agents. Diabetes Care 33:1300–1303
Buse JB, Nauck M, Forst T et al (2013) Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet 381:117–124
Buse JB, Vilsbøll T, Thurman J et al (2014) Contribution of liraglutide in the fixed-ratio combination of insulin degludec and liraglutide (IDegLira). Diabetes Care 37:2926–2933
Castle JR, Elander M (2019) Long-term safety and tolerability of dasiglucagon, a stable-in-solution glucagon analogue. Diabetes Technol Ther 21(2):94–96
Castle JR, Youssef JE, Wilson LM et al (2018) Randomized outpatient trial of single- and dual-hormone closed-loop systems that adapt to exercise using wearable sensors. Diabetes Care 41(7):1471–1477
Cengiz E (2013) Analysis of a remote system to closely monitor glycemia and insulin pump delivery – is this the beginning of a wireless transformation in diabetes management? J Diabetes Sci Technol 7(2):362–364
Cengiz E, Tamborlane WV (2009) A tale of two compartments: interstitial versus blood glucose monitoring. Diabetes Technol Ther 11(Suppl 1):S11–S16
Cengiz E, Sherr JL, Weinzimer SA et al (2011) New-generation diabetes management: glucose sensor-augmented insulin pump therapy. Expert Rev Med Devices 8(4):449–458
Chance RE, Frank BH (1993) Research, development, production, and safety of biosynthetic human insulin. Diabetes Care 16(Suppl 3):133–142
Chandran A, Bonafede MK, Nigam S et al (2015) Adherence to insulin pen therapy is associated with reduction in healthcare costs among patients with type 2 diabetes mellitus. Am Health Drug Benefits 8(3):148–158
Chase HP, Beck R, Tamborlane W et al (2005) A randomized multicenter trial comparing the GlucoWatch biographer with standard glucose monitoring in children with type 1 diabetes. Diabetes Care 28(5):1101–1106
Chase HP, Beck RW, Xing D et al (2007) Continuous glucose monitoring in youth with type 1 diabetes: 12-month follow-up of the Juvenile Diabetes Research Foundation continuous glucose monitoring randomized trial. Diabetes Technol Ther 12(7):507–515
Clarke WL, Cox D, Gonder-Frederick LA et al (1987) Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 10(5):622–628
Dalsgaard NB, Brønden A, Vilsbøll T, Knop FK (2017) Cardiovascular safety and benefits of GLP-1 receptor agonists. Expert Opin Drug Saf 16(3):351–363
Davies M, Pieber TR, Hartoft-Nielsen ML, Hansen OKH, Jabbour S, Rosenstock J (2017) Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes: a randomized clinical trial. JAMA 318(15):1460–1470
Diamant M, Nauck MA, Shaginian R, Malone JK et al (2014) Glucagon-like peptide 1 receptor agonist or bolus insulin with optimized basal insulin in type 2 diabetes. Diabetes Care 37(10):2763–2773
Dicembrini I, Nreu B, Scatena A, Andreozzi F, Sesti G, Mannucci E, Monami M (2017) Microvascular effects of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a meta-analysis of randomized controlled trials. Acta Diabetol 54(10):933–941
Drucker DJ, Nauck MA (2006) The incretin system: glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors in type 2 diabetes. Lancet 368(9548):1696–1705
Drucker DJ, Buse JB, Taylor K et al (2008) Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet 372:1240–1250
Drucker DJ, Habener JF, Holst JJ (2017) Discovery, characterization, and clinical development of the glucagon-like peptides. J Clin Invest 127(12):4217–4227
El-Khatib FH, Russell SJ, Magyar KL, Sinha M, McKeon K, Nathan DM, Damiano ER (2014) Autonomous and continuous adaptation of a bihormonal bionic pancreas in adults and adolescents with type 1 diabetes. J Clin Endocrinol Metab 99(5):1701–1711
El-Khatib et al (2017) Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet 389:P369–P380
Elleri D, Allen JM, Kumareswaran K et al (2013) Closed-loop basal insulin delivery over 36 hours in adolescents with type 1 diabetes: randomized clinical trial. Diabetes Care 36(4):838–844
Fonseca VA, Alvarado-Ruiz R, Raccah D et al (2012) Efficacy and safety of the once-daily GLP-1 receptor agonist lixisenatide in monotherapy: a randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono). Diabetes Care 35:1225–1231
Franch Nadal J, Mata Cases M, Mauricio Puente D (2016) Epidemiology and clinical management of type 2 diabetes mellitus and associated comorbidities in Spain (e-Management study). Med Clin (Barc) 147(Suppl 1):1–7
Frias J, Puig Domingo M, Meneghini L, Napoli R, Liu M, Soltes Rak E, Aroda VR (2018) More patients reach glycaemic control with a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) than with basal insulin at 12 weeks of treatment: a post hoc time-to-control analysis of LixiLan-O and LixiLan-L. Diabetes Obes Metab 20(9):2314–2318
Garg SK, Smith J, Beatson C et al (2009) Comparison of accuracy and safety of the SEVEN and the navigator continuous glucose monitoring systems. Diabetes Technol Ther 11(2):65–72
Gough SC, Bode BW (2015) Woo VC, etal 2015 one-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial. Diabetes Obes Metab 17(10):965–973. PMID: 25980900
Granhall C, Donsmark M, Blicher TM et al (2019) Safety and pharmacokinetics of single and multiple ascending doses of the novel oral human GLP-1 analogue, oral semaglutide, in healthy subjects and subjects with type 2 diabetes. Clin Pharmacokinet 58(6):781–791
Guja C, Miulescu R (2017) Semaglutide – the “new kid on the block” in the field of glucagon-like peptide-1 receptor agonists? Ann Transl Med 5(23):475–480
Haahr H, Heise T (2014) A review of the pharmacological properties of insulin degludec and their clinical relevance. Clin Pharmacokinet 53:787–800
Haidar A, Legault L, Dallaire M et al (2013) Glucose-responsive insulin and glucagon delivery (dual-hormone artificial pancreas) in adults with type 1 diabetes: a randomized crossover controlled trial. CMAJ 185(4):297–305
Harris SB, Kapor J, Lank CN et al (2010) Clinical inertia in patients with T2DM requiring insulin in family practice. Can Fam Physician 56:e418–e424
Heise T, Nosek L, Bottcher SG et al (2012) Ultralong-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab 14:944–950
Hirsch IB, Abelseth J, Bode BW et al (2008a) Sensor-augmented insulin pump therapy: results of the first randomized treat-to target study. Diabetes Technol Ther 10(5):377–383
Hirsch IB, Armstrong D, Bergenstal RM et al (2008b) Clinical application of emerging sensor technologies in diabetes management: consensus guidelines for continuous glucose monitoring (CGM). Diabetes Technol Ther 10(4):232–244
Hoevelmann U, Bysted BV, Mouritzen U, Macchi F, Lamers D, Kronshage B, Møller DV, Heise T (2018) Pharmacokinetic and pharmacodynamic characteristics of dasiglucagon, a novel soluble and stable glucagon analog. Diabetes Care 41(3):531–537
Home P (2019) Cardiovascular outcome trials of glucose-lowering medications: an update. Diabetologia 62(3):357–369
Hovorka R, Allen JM, Elleri D et al (2010) Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet 375(9716):743–751
Htike ZZ, Zaccardi F, Papamargaritis D et al (2017) Efficacy and safety of glucagon-like peptide-1 receptor agonists in type 2 diabetes: a systematic review and mixed-treatment comparison analysis. Diabetes Obes Metab 19(4):524–536
Jacobs PG, El Youssef J, Castle J, Bakhtiani P, Branigan D, Breen M, Bauer D, Preiser N, Leonard G, Stonex T, Ward WK (2014) Automated control of an adaptive bihormonal, dual-sensor artificial pancreas and evaluation during inpatient studies. IEEE Trans Biomed Eng 61(10):2569–2581
Jacobs PG, El Youssef J, Reddy R et al (2016) Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy. Diabetes Obes Metab 18(11):1110–1119
JDRF Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2009) The effect of continuous glucose monitoring in well-controlled type 1 diabetes. Diabetes Care 32(8):1378–1383
JDRF Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2010) Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 12(9):679–684
Jensen L, Kupcova V, Arold G, Pettersson J, Hjerpsted JB (2018) Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment. Diabetes Obes Metab 20(4):998–1005
Kaiserman K, Buckingham BA, Prakasam G, Gunville F, Slover RH, Wang Y, Nguyen X, Welsh JB (2013) Acceptability and utility of the mySentry remote glucose monitoring system. J Diabetes Sci Technol 7(2):356–361
Kalra S, Gupta Y (2016) Endocrine and metabolic effects of glucagon like peptide 1 receptor agonists (GLP1RA). J Pak Med Assoc 66(3):357–359
Kalra S, Baruah MP, Sahay RK et al (2016) Glucagon-like peptide-1 receptor agonists in the treatment of type 2 diabetes: past, present, and future. Indian J Endocrinol Metab 20(2):254–267
Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A (2017) Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia 60(8):1390–1399
Khunti K, Millar-Jones D (2017) Clinical inertia to insulin initiation and intensification in the UK: a focused literature review. Prim Care Diabetes 11:3–12
Khunti K, Wolden ML, Thorsted BL et al (2013) Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care 36:3411–3417
Kordonouri O, Pankowska E, Rami B et al (2010) Sensor-augmented pump therapy from the diagnosis of childhood type 1 diabetes: results of the Paediatric Onset Study (ONSET) after 12 months of treatment. Diabetologia 53(12):2487–2495
Koschinsky T, Heinemann L (2001) Sensors for glucose monitoring: technical and clinical aspects. Diabetes Metab Res Rev 17(2):113–123
Kropff J, Choudhary P, Neupane S et al (2017) Accuracy and longevity of an implantable continuous glucose sensor in the PRECISE study: a 180-day, prospective, multicenter, pivotal trial. Diabetes Care 40(1):63–68
Kumareswaran K, Thabit H, Leelarathna L et al (2014) Feasibility of closed-loop insulin delivery in type 2 diabetes: a randomized controlled study. Diabetes Care 37(5):1198–1203
Landgraf W, Sandow J (2016) Equivalent recombinant human insulin preparations and their place in therapy. Eur Endocrinol 12(1):12–17
Leelarathna L et al (2014) Evaluating the performance of a novel embedded closed-loop system. J Diabetes Sci Technol 8(2):267–272
Lehrke M, Marx N (2017) Diabetes mellitus and heart failure. Am J Med 130(6S):S40–S50
Leite NC, Villela-Nogueira CA, Cardoso CR, Salles GF (2014) Non-alcoholic fatty liver disease and diabetes: from physiopathological interplay to diagnosis and treatment. World J Gastroenterol 20(26):8377–8392
Lipska KJ, Yao X, Herrin J et al (2017) Trends in drug utilization, glycemic control, and rates of severe hypoglycemia, 2006–2013. Diabetes Care 40:468–475
Luijf YM, DeVries JH, Zwinderman K et al (2013) Day and night closed-loop control in adults with type 1 diabetes: a comparison of two closed-loop algorithms driving continuous subcutaneous insulin infusion versus patient self-management. Diabetes Care 36(12):3882–3887
Madsbad S (2016) Review of head-to-head comparisons of glucagon-like peptide-1 receptor agonists. Diabetes Obes Metab 18(4):317–332
Maniatis AK, Klingensmith GJ, Slover RH et al (2001) Continuous subcutaneous insulin infusion therapy for children and adolescents: an option for routine diabetes care. Pediatrics 107(2):351–356
Mann JFE, Ørsted DD, Buse JB (2017) Liraglutide and renal outcomes in type 2 diabetes. N Engl J Med 377(22):2197–2198
Mannucci E, Monami M (2017) Cardiovascular safety of Incretin-based therapies in type 2 diabetes: systematic review of integrated analyses and randomized controlled trials. Adv Ther 34(1):1–40
Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsbøll T, SUSTAIN-6 Investigators (2016) Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med 375(19):1834–1844
Marso SP, McGuire DK, Zinman B et al (2017) Efficacy and safety of degludec versus glargine in type 2 diabetes. N Engl J Med 377:723–732
Mastrototaro J, Shin J, Marcus A et al (2008) The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. Diabetes Technol Ther 10(5):385–390
Mbanya JC, Sandow J, Landgraf W, Owens DR (2017) Recombinant human insulin in global diabetes management – focus on clinical efficacy. Eur Endocrinol 13(1):21–25
Merger SR, Kerner W, Stadler M, Zeyfang A, Jehle P, Müller-Korbsch M, Holl RW; DPV Initiative; German BMBF Competence Network Diabetes mellitus (2016) Prevalence and comorbidities of double diabetes. Diabetes Res Clin Pract 119:48–56
Monami M, Nreu B, Scatena A, Giannini S, Andreozzi F, Sesti G, Mannucci E (2017) Glucagon-like peptide-1 receptor agonists and atrial fibrillation: a systematic review and meta-analysis of randomised controlled trials. J Endocrinol Investig 40(11):1251–1258
Muskiet MHA, Tonneijck L, Huang Y et al (2018) Lixisenatide and renal outcomes in patients with type 2 diabetes and acute coronary syndrome: an exploratory analysis of the ELIXA randomised, placebo-controlled trial. Lancet Diabetes Endocrinol 6(11):859–869
Neumiller JJ, Campbell RK (2009) Liraglutide: a once-daily incretin mimetic for the treatment of type 2 diabetes mellitus. Ann Pharmacother 43:1433–1444
Nuffer W, Guesnier A, Trujillo JM (2018) A review of the new GLP-1 receptor agonist/basal insulin fixed-ratio combination products. Ther Adv Endocrinol Metab 9(3):69–79
O’Connell MA, Donath S, O’Neal DN et al (2009) Glycaemic impact of patient-led use of sensor-guided pump therapy in type 1 diabetes: a randomised controlled trial. Diabetologia 52(7):1250–1257
Okere AN, Montesdeoca J, Glasper A, Diaby V (2018) An evaluation of the clinical therapeutic effect of Lixisenatide in type 2 diabetes patients: a systematic literature review. Curr Diabetes Rev 14(4):363–375
Pankowska E, Skorka A, Szypowska A et al (2005) Memory of insulin pumps and their record as a source of information about insulin therapy in children and adolescents with type 1 diabetes. Diabetes Technol Ther 7(2):308–314
Patterson CC, Dahlquist GG, Gyurus E et al (2009) Incidence trends for childhood type 1 diabetes in Europe during 1989–2003 and predicted new cases 2005–2020: a multicentre prospective registration study. Lancet 373(9680):2027–2033
Peterson SC, Barry AR (2018) Effect of glucagon-like peptide-1 receptor agonists on all-cause mortality and cardiovascular outcomes: a meta-analysis. Curr Diabetes Rev 14(3):273–279
Petrosyan Y, Bai YQ, Koné Pefoyo AJ, Gruneir A, Thavorn K, Maxwell CJ, Bronskill SE, Wodchis WP (2017) The relationship between diabetes care quality and diabetes-related hospitalizations and the modifying role of comorbidity. Can J Diabetes 41(1):17–25
Pfeffer MA, Claggett B, Diaz R et al (2015) Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med 373(23):2247–2257
Plotnick LP, Clark LM, Brancati FL et al (2003) Safety and effectiveness of insulin pump therapy in children and adolescents with type 1 diabetes. Diabetes Care 26(4):1142–1146. PMID: 29285508
Richter L, Freisinger E, Lüders F, Gebauer K, Meyborg M, Malyar NM (2018) Impact of diabetes type on treatment and outcome of patients with peripheral artery disease. Diab Vasc Dis Res 15(6):504–510
Rosenstock J, Aronson R, Grunberger G et al (2016a) Benefits of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide, versus insulin glargine and lixisenatide monocomponents in type 2 diabetes inadequately controlled on oral agents: the LixiLan-O randomized trial. Diabetes Care 39(11):2026–2035
Rosenstock J, Diamant M, Aroda VR, Silvestre L et al (2016b) Efficacy and safety of LixiLan, a titratable fixed-ratio combination of lixisenatide and insulin glargine, versus insulin glargine in type 2 diabetes inadequately controlled on metformin monotherapy: the LixiLan proof-of-concept randomized trial. Diabetes Care 39(9):1579–1586
Sandow J, Landgraf W, Becker R, Seipke S (2015) Equivalent recombinant human insulin preparations and their place in therapy. Eur Endocrinol 11(1):10–16
Sharma D, Verma S, Vaidya S, Kalia K, Tiwari V (2018) Recent updates on GLP-1 agonists: current advancements & challenges. Biomed Pharmacother 108:952–962
Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbøl JD, Hansen T, Bain SC (2017) Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol 5(4):251–260
Stark Casagrande S, Fradkin JE, Saydah SH, Rust KF, Cowie CC (2013) The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care 36(8):2271–2279
Sulli N, Shashaj B (2003) Continuous subcutaneous insulin infusion in children and adolescents with diabetes mellitus: decreased HbA1c with low risk of hypoglycemia. J Pediatr Endocrinol Metab 16(3):393–399
Swan KL, Weinzimer SA, Dziura JD et al (2008) Effect of puberty on the pharmacodynamic and pharmacokinetic properties of insulin pump therapy in youth with type 1 diabetes. Diabetes Care 31(1):44–46
Swan KL, Dziura JD, Steil GM et al (2009) Effect of age of infusion site and type of rapid-acting analog on pharmacodynamic parameters of insulin boluses in youth with type 1 diabetes receiving insulin pump therapy. Diabetes Care 32(2):240–244
Tamborlane WV, Beck RW, Bode BW et al (2008) Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 359(14):1464–1476
Tauschmann M, Hovorka R (2017) Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes. Expert Opin Drug Deliv 14(12):1367–1377
Thabit H, Leelarathna L, Wilinska ME et al (2015) Accuracy of continuous glucose monitoring during three closed-loop home studies under free-living conditions. Diabetes Technol Ther 17(11):801–807
The DCCT RESEARCH GROUP (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329(14):977–986
Valentine V, Goldman J, Shubrook JH (2017) Rationale for, initiation and titration of the basal insulin/GLP-1RA fixed-ratio combination products, IDegLira and IGlarLixi, for the management of type 2 diabetes. Diabetes Ther 8(4):739–752
Vilsbøll T, Christensen M, Junker AE et al (2012) Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. BMJ 344:7771
Vilsbøll T, Vora J, Jarlov H, Kvist K, Blonde L (2016) Type 2 diabetes patients reach target glycemic control faster using IDegLira than either insulin degludec or liraglutide given alone. Clin Drug Investig 36(4):293–303. PMID 26894800
Weinstein RL, Schwartz SL, Brazg RL et al (2007) Accuracy of the 5-day FreeStyle navigator continuous glucose monitoring system: comparison with frequent laboratory reference measurements. Diabetes Care 30(5):1125–1130
Weinzimer SA, Steil GM, Swan KL et al (2008) Fully automated closed loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas. Diabetes Care 31(5):934–939
Werner U (2014) Effects of the GLP-1 receptor agonist lixisenatide on postprandial glucose and gastric emptying–preclinical evidence. J Diabetes Complicat 28:110–114
Wielgosz A, Dai S, Walsh P, McCrea-Logie J, Celebican E (2018) Comorbid conditions in Canadians hospitalized because of diabetes. Can J Diabetes 42(1):106–111
Willi SM, Planton J, Egede L et al (2003) Benefits of continuous subcutaneous insulin infusion in children with type 1 diabetes. J Pediatr 143(6):796–801
Wilson DM, Beck RW, Tamborlane WV et al (2007) The accuracy of the FreeStyle navigator continuous glucose monitoring system in children with type 1 diabetes. Diabetes Care 30(1):59–64
Wilson LM, Castle JR (2018) Stable liquid glucagon: beyond emergency hypoglycemia rescue. J Diabetes Sci Technol 12(4):847–885
Wolpert HA (2008) The nuts and bolts of achieving end points with real-time continuous glucose monitoring. Diabetes Care 31(Suppl. 2):S146–S149
Wysham C, Grimm M, Chen S (2013) Once weekly exenatide: efficacy, tolerability and place in therapy. Diabetes Obes Metab 15(10):871–881
Wysham CH, Campos C, Kruger D (2018) Safety and efficacy of insulin degludec/liraglutide (IDegLira) and insulin glargine U100/lixisenatide (iGlarLixi), two novel co-formulations of a basal insulin and a glucagon-like peptide-1 receptor agonist, in patients with diabetes not adequately controlled on oral antidiabetic medications. Clin Diabetes 36(2):149–159
Zander M, Madsbad S, Madsen JL et al (2002) Effect of 6-week course of glucagon-like peptide 1 on glycaemic control, insulin sensitivity, and 𝛽-cell function in type 2 diabetes: a parallel-group study. Lancet 359:824–830
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Sandow, J. (2020). Pharmacodynamic Evaluation: Diabetic Methodologies. In: Hock, F., Gralinski, M. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Cham. https://doi.org/10.1007/978-3-319-56637-5_33-1
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Publisher Name: Springer, Cham
Print ISBN: 978-3-319-56637-5
Online ISBN: 978-3-319-56637-5
eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences