title: Safety and efficacy of teneligliptin: a novel DPP-4 inhibitor for hemodialysis patients with type 2 diabetes.
abstract: OBJECTIVE
  Teneligliptin is a novel DPP-4 inhibitor in development for treating type 2 diabetes mellitus that does not require dose adjustment for diabetic patients with end-stage renal disease; however, it had not been known whether or not teneligliptin is safe or potent in dialysis patients. We conducted a prospective study to assess the utility of teneligliptin for diabetic patients undergoing hemodialysis.
  
  
  METHODS
  Blood glucose, glycated albumin, and HbA1c were measured every 4 weeks, at 4, 12, 20, and 28 weeks, and every 8 weeks, respectively, for patients treated with teneligliptin (n = 14; 7 patients newly started and 7 that switched from other medications) and patients of a control group who continued ongoing antidiabetic therapy (n = 29).
  
  
  RESULTS
  Blood glucose level showed a 36.7 mg/dl decrease from 4 weeks in the teneligliptin group (p < 0.05). The differences in glycated albumin (at 28 w) and HbA1c (at 24 w) between the teneligliptin group and the control group were -3.1 % (p < 0.05) and -0.57 % (p = 0.057), respectively. These parameters also decreased in patients who switched from voglibose 0.2 mg t.i.d. or vildagliptin 50 mg qd after teneligliptin administration. No case with hypoglycemia was identified. One patient had the dose of a laxative administered for constipation increased; however, no patient ceased teneligliptin due to side effects.
  
  
  CONCLUSIONS
  Teneligliptin 20 mg is well tolerated, safe, and significantly improves glycemic control in diabetic patients with end-stage renal disease. Teneligliptin 20 mg once daily was considered to be more potent than voglibose 0.2 mg t.i.d. or vildagliptin 50 mg qd.
authors.affiliation: Department of Urology and Nephrology, Nagakubo Hospital, 6907-1, Yaho, Kunitachi, Tokyo, 186-0011, Japan, hideotsuki2004@hotmail.com.
authors.forename: Hideo
authors.initials: H
authors.lastname: Otsuki
authors.forename: Takeo
authors.initials: T
authors.lastname: Kosaka
authors.forename: Kenzo
authors.initials: K
authors.lastname: Nakamura
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Shimomura
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Kuwahara
authors.forename: Takuji
authors.initials: T
authors.lastname: Tsukamoto
mesh_terms: D000218:Adamantane / Q000031:analogs & derivatives / Q000627:therapeutic use; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D017127:Glycation End Products, Advanced; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007294:Inositol / Q000031:analogs & derivatives / Q000627:therapeutic use; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000627:therapeutic use; D011446:Prospective Studies; D011720:Pyrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D011759:Pyrrolidines / Q000627:therapeutic use; D006435:Renal Dialysis; D012709:Serum Albumin / Q000378:metabolism; D053778:Thiazolidines / Q000009:adverse effects / Q000627:therapeutic use*; D000077597:Vildagliptin; D000093423:Glycated Serum Albumin
chemical_list: D000218:Adamantane; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D017127:Glycation End Products, Advanced; D007004:Hypoglycemic Agents; D007294:Inositol; D009570:Nitriles; D011720:Pyrazoles; D011759:Pyrrolidines; D012709:Serum Albumin; D053778:Thiazolidines; D000077597:Vildagliptin; D000093423:Glycated Serum Albumin; C579035:3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine; C517652:hemoglobin A1c protein, human; C102817:voglibose