메뉴 건너뛰기




Volumn 19, Issue 10, 2017, Pages 1436-1445

Pharmacodynamics, pharmacokinetics and safety of multiple ascending doses of the novel dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 agonist RG7697 in people with type 2 diabetes mellitus

Author keywords

dual GIP GLP 1 agonist; NNC0090 2746; pharmacodynamics; pharmacokinetics; RG7697, RO6811135; safety; type 2 diabetes mellitus

Indexed keywords

ANTIDIABETIC AGENT; GLUCAGON LIKE PEPTIDE 1 RECEPTOR AGONIST; GLUCOSE; HEMOGLOBIN A1C; INSULIN; NNC 0090 2746; PLACEBO; POLYPEPTIDE; RG 7697; RO 6811135; UNCLASSIFIED DRUG; GASTRIC INHIBITORY POLYPEPTIDE; GLUCAGON LIKE PEPTIDE 1; NEW DRUG;

EID: 85029810647     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.13024     Document Type: Article
Times cited : (64)

References (40)
  • 1
    • 85029820563 scopus 로고    scopus 로고
    • World Health Organization., Global Report on Diabetes, Geneva, Switzerland., Accessed December 6, 2016
    • World Health Organization. Global Report on Diabetes. Geneva, Switzerland. 2016 http://apps.who.int/iris/bitstream/10665/204871/1/9789241565257_eng.pdf. Accessed December 6, 2016.
    • (2016)
  • 2
    • 0034641568 scopus 로고    scopus 로고
    • Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study
    • Stratton IM, Adler AI, Neil HA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321(7258):405–412.
    • (2000) BMJ. , vol.321 , Issue.7258 , pp. 405-412
    • Stratton, I.M.1    Adler, A.I.2    Neil, H.A.3
  • 3
    • 77955413485 scopus 로고    scopus 로고
    • The magnitude of association between overweight and obesity and the risk of diabetes: a meta-analysis of prospective cohort studies
    • Abdullah A, Peeters A, de Courten M, et al. The magnitude of association between overweight and obesity and the risk of diabetes: a meta-analysis of prospective cohort studies. Diabetes Res Clin Pract. 2010;89(3):309–319.
    • (2010) Diabetes Res Clin Pract. , vol.89 , Issue.3 , pp. 309-319
    • Abdullah, A.1    Peeters, A.2    de Courten, M.3
  • 4
    • 84861137983 scopus 로고    scopus 로고
    • Association between glycosylated hemoglobin and intentional weight loss in overweight and obese patients with type 2 diabetes mellitus: a retrospective cohort study
    • Shantha GP, Kumar AA, Kahan S, Cheskin LJ. Association between glycosylated hemoglobin and intentional weight loss in overweight and obese patients with type 2 diabetes mellitus: a retrospective cohort study. Diabetes Educ. 2012;38(3):417–426.
    • (2012) Diabetes Educ. , vol.38 , Issue.3 , pp. 417-426
    • Shantha, G.P.1    Kumar, A.A.2    Kahan, S.3    Cheskin, L.J.4
  • 5
    • 0029043139 scopus 로고
    • Cell and molecular biology of the incretin hormones glucagon-like peptide-I and glucose-dependent insulin releasing polypeptide
    • Fehmann HC, Goke R, Goke B. Cell and molecular biology of the incretin hormones glucagon-like peptide-I and glucose-dependent insulin releasing polypeptide. Endocr Rev. 1995;16(3):390–410.
    • (1995) Endocr Rev. , vol.16 , Issue.3 , pp. 390-410
    • Fehmann, H.C.1    Goke, R.2    Goke, B.3
  • 6
    • 34248223285 scopus 로고    scopus 로고
    • Biology of incretins: GLP–1 and GIP
    • Baggio LL, Drucker DJ. Biology of incretins: GLP–1 and GIP. Gastroenterology. 2007;132(6):2131–2157.
    • (2007) Gastroenterology. , vol.132 , Issue.6 , pp. 2131-2157
    • Baggio, L.L.1    Drucker, D.J.2
  • 7
    • 0030068620 scopus 로고    scopus 로고
    • Gastric emptying, glucose responses, and insulin secretion after a liquid test meal: effects of exogenous glucagon-like peptide-1 (GLP–1)-(7-36) amide in type 2 (noninsulin-dependent) diabetic patients
    • Willms B, Werner J, Holst JJ, Orskov C, Creutzfeldt W, Nauck MA. Gastric emptying, glucose responses, and insulin secretion after a liquid test meal: effects of exogenous glucagon-like peptide-1 (GLP–1)-(7-36) amide in type 2 (noninsulin-dependent) diabetic patients. J Clin Endocrinol Metab. 1996;81:327–332.
    • (1996) J Clin Endocrinol Metab. , vol.81 , pp. 327-332
    • Willms, B.1    Werner, J.2    Holst, J.J.3    Orskov, C.4    Creutzfeldt, W.5    Nauck, M.A.6
  • 9
    • 0015791989 scopus 로고
    • Stimulation of insulin secretion by gastric inhibitory polypeptide in man
    • Dupre J, Ross SA, Watson D, Brown JC. Stimulation of insulin secretion by gastric inhibitory polypeptide in man. J Clin Endocrinol Metab. 1973;37(5):826–828.
    • (1973) J Clin Endocrinol Metab. , vol.37 , Issue.5 , pp. 826-828
    • Dupre, J.1    Ross, S.A.2    Watson, D.3    Brown, J.C.4
  • 10
    • 0038574573 scopus 로고    scopus 로고
    • Gastric inhibitory polypeptide (GIP) dose-dependently stimulates glucagon secretion in healthy human subjects at euglycaemia
    • Meier JJ, Gallwitz B, Siepmann N, et al. Gastric inhibitory polypeptide (GIP) dose-dependently stimulates glucagon secretion in healthy human subjects at euglycaemia. Diabetologia. 2003;46(6):798–801.
    • (2003) Diabetologia. , vol.46 , Issue.6 , pp. 798-801
    • Meier, J.J.1    Gallwitz, B.2    Siepmann, N.3
  • 11
    • 82255185915 scopus 로고    scopus 로고
    • Glucose-dependent insulinotropic polypeptide: a bifunctional glucose-dependent regulator of glucagon and insulin secretion in humans
    • Christensen M, Vedtofte J, Holst JJ, Vilsbøll T, Knop FK. Glucose-dependent insulinotropic polypeptide: a bifunctional glucose-dependent regulator of glucagon and insulin secretion in humans. Diabetes. 2011;60(12):3103–3109.
    • (2011) Diabetes. , vol.60 , Issue.12 , pp. 3103-3109
    • Christensen, M.1    Vedtofte, J.2    Holst, J.J.3    Vilsbøll, T.4    Knop, F.K.5
  • 12
    • 1642395091 scopus 로고    scopus 로고
    • Gastric inhibitory polypeptide does not inhibit gastric emptying in humans
    • Meier JJ, Goetze O, Anstipp J, et al. Gastric inhibitory polypeptide does not inhibit gastric emptying in humans. Am J Physiol Endocrinol Metab. 2004;286:E621–E625.
    • (2004) Am J Physiol Endocrinol Metab. , vol.286 , pp. E621-E625
    • Meier, J.J.1    Goetze, O.2    Anstipp, J.3
  • 13
    • 0027391607 scopus 로고
    • Preserved incretin activity of glucagon-like peptide 1 [7–36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus
    • Nauck MA, Heimesaat MM, Orskov C, Holst JJ, Ebert R, Creutzfeldt W. Preserved incretin activity of glucagon-like peptide 1 [7–36 amide] but not of synthetic human gastric inhibitory polypeptide in patients with type-2 diabetes mellitus. J Clin Invest. 1993;91:301–307.
    • (1993) J Clin Invest. , vol.91 , pp. 301-307
    • Nauck, M.A.1    Heimesaat, M.M.2    Orskov, C.3    Holst, J.J.4    Ebert, R.5    Creutzfeldt, W.6
  • 14
    • 0028224617 scopus 로고
    • The insulinotropic actions of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (7-37) in normal and diabetic subjects
    • Elahi D, McAloon Dyke M, Fukagawa NK, et al. The insulinotropic actions of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (7-37) in normal and diabetic subjects. Regul Pept. 1994;51:63–74.
    • (1994) Regul Pept. , vol.51 , pp. 63-74
    • Elahi, D.1    McAloon Dyke, M.2    Fukagawa, N.K.3
  • 15
    • 0036068322 scopus 로고    scopus 로고
    • Inhibition of gastric inhibitory polypeptide signaling prevents obesity
    • Miyawaki K, Yamada Y, Ban N, et al. Inhibition of gastric inhibitory polypeptide signaling prevents obesity. Nat Med. 2002;8(7):738–742.
    • (2002) Nat Med. , vol.8 , Issue.7 , pp. 738-742
    • Miyawaki, K.1    Yamada, Y.2    Ban, N.3
  • 16
    • 35648940236 scopus 로고    scopus 로고
    • The insulinotropic effect of GIP is impaired in patients with chronic pancreatitis and secondary diabetes mellitus as compared to patients with chronic pancreatitis and normal glucose tolerance
    • Knop FK, Vilsbøll T, Højberg PV, et al. The insulinotropic effect of GIP is impaired in patients with chronic pancreatitis and secondary diabetes mellitus as compared to patients with chronic pancreatitis and normal glucose tolerance. Regul Pept. 2007;144:123–130.
    • (2007) Regul Pept. , vol.144 , pp. 123-130
    • Knop, F.K.1    Vilsbøll, T.2    Højberg, P.V.3
  • 17
    • 58149467276 scopus 로고    scopus 로고
    • Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes
    • Højberg PV, Vilsbøll T, Rabøl R, et al. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009;52(2):199–207.
    • (2009) Diabetologia. , vol.52 , Issue.2 , pp. 199-207
    • Højberg, P.V.1    Vilsbøll, T.2    Rabøl, R.3
  • 18
    • 79955583163 scopus 로고    scopus 로고
    • Administration of an acylated GLP-1 and GIP preparation provides added beneficial glucose-lowering and insulinotropic actions over single incretins in mice with Type 2 diabetes and obesity
    • Gault VA, Kerr BD, Harriott P, Flatt PR. Administration of an acylated GLP-1 and GIP preparation provides added beneficial glucose-lowering and insulinotropic actions over single incretins in mice with Type 2 diabetes and obesity. Clin Sci. 2011;121(3):107–117.
    • (2011) Clin Sci. , vol.121 , Issue.3 , pp. 107-117
    • Gault, V.A.1    Kerr, B.D.2    Harriott, P.3    Flatt, P.R.4
  • 19
    • 59849092759 scopus 로고    scopus 로고
    • Antidiabetic effects of sub-chronic activation of the GIP receptor alone and in combination with background exendin-4 therapy in high fat fed mice
    • Irwin N, Hunter K, Frizzell N, Flatt PR. Antidiabetic effects of sub-chronic activation of the GIP receptor alone and in combination with background exendin-4 therapy in high fat fed mice. Regul Pept. 2009;153:70–76.
    • (2009) Regul Pept. , vol.153 , pp. 70-76
    • Irwin, N.1    Hunter, K.2    Frizzell, N.3    Flatt, P.R.4
  • 20
    • 34250155196 scopus 로고    scopus 로고
    • Comparison of the anti-diabetic effects of GIP- and GLP-1-receptor activation in obese diabetic (ob/ob) mice: studies with DPP IV resistant N-AcGIP and exendin(1-39)amide
    • Irwin N, McClean PL, Cassidy RS, et al. Comparison of the anti-diabetic effects of GIP- and GLP-1-receptor activation in obese diabetic (ob/ob) mice: studies with DPP IV resistant N-AcGIP and exendin(1-39)amide. Diabetes Metab Res Rev. 2007;23(7):572–579.
    • (2007) Diabetes Metab Res Rev. , vol.23 , Issue.7 , pp. 572-579
    • Irwin, N.1    McClean, P.L.2    Cassidy, R.S.3
  • 21
    • 84890043525 scopus 로고    scopus 로고
    • Unimolecular dual incretins maximize metabolic benefits in rodents, monkeys, and humans
    • Finan B, Ma T, Ottaway N, et al. Unimolecular dual incretins maximize metabolic benefits in rodents, monkeys, and humans. Sci Transl Med. 2013;5(209):209ra151.
    • (2013) Sci Transl Med. , vol.5 , Issue.209 , pp. 209ra151
    • Finan, B.1    Ma, T.2    Ottaway, N.3
  • 22
    • 85026379010 scopus 로고    scopus 로고
    • Pharmacodynamics, pharmacokinetics, safety and tolerability of the novel dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 agonist RG7697 after single subcutaneous administration in healthy subjects
    • 20171–8
    • Portron A, Jadidi S, Sarkar N, DiMarchi R, Schmitt C. Pharmacodynamics, pharmacokinetics, safety and tolerability of the novel dual glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 agonist RG7697 after single subcutaneous administration in healthy subjects. Diabetes Obes Metab. 2017:1–8.
    • (2017) Diabetes Obes Metab
    • Portron, A.1    Jadidi, S.2    Sarkar, N.3    DiMarchi, R.4    Schmitt, C.5
  • 23
    • 0036365047 scopus 로고    scopus 로고
    • Evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications
    • American Diabetes Association. Evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. Diabetes Care. 2002;25:202–212.
    • (2002) Diabetes Care. , vol.25 , pp. 202-212
  • 24
    • 18144388647 scopus 로고    scopus 로고
    • Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes
    • Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes. Diabetes Care. 2005;28(5):1245.
    • (2005) Diabetes Care. , vol.28 , Issue.5 , pp. 1245
  • 26
    • 0015702659 scopus 로고
    • The dependence of paracetamol absorption on the rate of gastric emptying
    • Heading RC, Nimmo J, Prescott LF, Tothill P. The dependence of paracetamol absorption on the rate of gastric emptying. Br J Pharmacol. 1973;47:415–421.
    • (1973) Br J Pharmacol. , vol.47 , pp. 415-421
    • Heading, R.C.1    Nimmo, J.2    Prescott, L.F.3    Tothill, P.4
  • 27
    • 33644618433 scopus 로고    scopus 로고
    • The biology of incretin hormones
    • Drucker DJ. The biology of incretin hormones. Cell Metab. 2006;3(3):153–165.
    • (2006) Cell Metab. , vol.3 , Issue.3 , pp. 153-165
    • Drucker, D.J.1
  • 28
    • 0027281591 scopus 로고
    • Relationship between oral glucose tolerance and gastric emptying in normal healthy subjects
    • Horowitz M, Edelbroek MA, Wishart JM, Straathof JW. Relationship between oral glucose tolerance and gastric emptying in normal healthy subjects. Diabetologia. 1993;36(9):857–862.
    • (1993) Diabetologia. , vol.36 , Issue.9 , pp. 857-862
    • Horowitz, M.1    Edelbroek, M.A.2    Wishart, J.M.3    Straathof, J.W.4
  • 30
    • 0036959991 scopus 로고    scopus 로고
    • Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycemic clamp experiments in healthy volunteers
    • Nauck MA, Heimesaat MM, Behle K, et al. Effects of glucagon-like peptide 1 on counterregulatory hormone responses, cognitive functions, and insulin secretion during hyperinsulinemic, stepped hypoglycemic clamp experiments in healthy volunteers. J Clin Endocrinol Metab. 2002;87:1239–1246.
    • (2002) J Clin Endocrinol Metab. , vol.87 , pp. 1239-1246
    • Nauck, M.A.1    Heimesaat, M.M.2    Behle, K.3
  • 31
    • 78649388633 scopus 로고    scopus 로고
    • Differential incretin effects of GIP and GLP-1 on gastric emptying, appetite, and insulin-glucose homeostasis
    • e315
    • Edholm T, Degerblad M, Gryback P, et al. Differential incretin effects of GIP and GLP-1 on gastric emptying, appetite, and insulin-glucose homeostasis. Neurogastroenterol Motil. 2010;22:1191–1200, e315.
    • (2010) Neurogastroenterol Motil. , vol.22 , pp. 1191-1200
    • Edholm, T.1    Degerblad, M.2    Gryback, P.3
  • 32
    • 0028988142 scopus 로고
    • Kinetics of HbA1c, glycated albumin, and fructosamine and analysis of their weight functions against preceding plasma glucose level
    • Tahara Y, Shima K. Kinetics of HbA1c, glycated albumin, and fructosamine and analysis of their weight functions against preceding plasma glucose level. Diabetes Care. 1995;18(4):440–447.
    • (1995) Diabetes Care. , vol.18 , Issue.4 , pp. 440-447
    • Tahara, Y.1    Shima, K.2
  • 33
    • 84920814490 scopus 로고    scopus 로고
    • Gastrointestinal adverse events of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a systematic review and network meta-analysis
    • Sun F, Chai S, Yu K, et al. Gastrointestinal adverse events of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetes Technol Ther. 2015;17:35–42.
    • (2015) Diabetes Technol Ther. , vol.17 , pp. 35-42
    • Sun, F.1    Chai, S.2    Yu, K.3
  • 34
    • 34447267513 scopus 로고    scopus 로고
    • Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis
    • Amori RE, Lau J, Pittas AG. Efficacy and safety of incretin therapy in type 2 diabetes: systematic review and meta-analysis. JAMA. 2007;298(2):194–206.
    • (2007) JAMA. , vol.298 , Issue.2 , pp. 194-206
    • Amori, R.E.1    Lau, J.2    Pittas, A.G.3
  • 35
    • 84864674632 scopus 로고    scopus 로고
    • Elevated amylse and lipase levels in patients using glucagon like peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors in the outpatient setting
    • Lando HM, Alattar M, Dua AP. Elevated amylse and lipase levels in patients using glucagon like peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors in the outpatient setting. Endocr Pract. 2012;18(4):472–477.
    • (2012) Endocr Pract. , vol.18 , Issue.4 , pp. 472-477
    • Lando, H.M.1    Alattar, M.2    Dua, A.P.3
  • 36
    • 84875077076 scopus 로고    scopus 로고
    • Exenatide at therapeutic and supratherapeutic concentrations does not prolong the QTc interval in healthy subjects
    • Darpö B, Sager P, MacConell L, et al. Exenatide at therapeutic and supratherapeutic concentrations does not prolong the QTc interval in healthy subjects. Br J Clin Pharmacol. 2013;75(4):979–989.
    • (2013) Br J Clin Pharmacol. , vol.75 , Issue.4 , pp. 979-989
    • Darpö, B.1    Sager, P.2    MacConell, L.3
  • 37
    • 84873554686 scopus 로고    scopus 로고
    • Effects of exenatide and liraglutide on heart rate, blood pressure and body weight: systematic review and meta-analysis
    • 2013;3
    • Robinson LE, Holt TA, Rees K, Randeva HS, O'Hare JP. Effects of exenatide and liraglutide on heart rate, blood pressure and body weight: systematic review and meta-analysis. BMJ Open. 2013;3:e001986.
    • BMJ Open
    • Robinson, L.E.1    Holt, T.A.2    Rees, K.3    Randeva, H.S.4    O'Hare, J.P.5
  • 38
    • 84979277035 scopus 로고    scopus 로고
    • Effects of the glucagon-like peptide-1 receptor agonist liraglutide on systolic function in patients with coronary artery disease and type 2 diabetes: a randomized double-blind placebo-controlled crossover study
    • Kumarathurai P, Anholm C, Nielsen OW, et al. Effects of the glucagon-like peptide-1 receptor agonist liraglutide on systolic function in patients with coronary artery disease and type 2 diabetes: a randomized double-blind placebo-controlled crossover study. Cardiovasc Diabetol. 2016;15:105.
    • (2016) Cardiovasc Diabetol. , vol.15 , pp. 105
    • Kumarathurai, P.1    Anholm, C.2    Nielsen, O.W.3
  • 39
    • 84901769522 scopus 로고    scopus 로고
    • Albiglutide does not prolong QTc interval in healthy subjects: a thorough ECG study
    • Darpö B, Zhou M, Matthews J, et al. Albiglutide does not prolong QTc interval in healthy subjects: a thorough ECG study. Diabetes Ther. 2014;5(1):141–153.
    • (2014) Diabetes Ther. , vol.5 , Issue.1 , pp. 141-153
    • Darpö, B.1    Zhou, M.2    Matthews, J.3
  • 40
    • 84920855422 scopus 로고    scopus 로고
    • Effect of glucagon-like peptide-1 receptor agonists on lipid profiles among type 2 diabetes: a systematic review and network meta-analysis
    • Sun F, Wu S, Wang J, et al. Effect of glucagon-like peptide-1 receptor agonists on lipid profiles among type 2 diabetes: a systematic review and network meta-analysis. Clin Ther. 2015;37(1):225–241.
    • (2015) Clin Ther. , vol.37 , Issue.1 , pp. 225-241
    • Sun, F.1    Wu, S.2    Wang, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.