title: The efficacy and safety of teneligliptin added to ongoing metformin monotherapy in patients with type 2 diabetes: a randomized study with open label extension.
abstract: OBJECTIVE
  The study investigated the efficacy and tolerability of teneligliptin co-administered to patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled by stable metformin monotherapy ≥ 1000 mg/day.
  
  
  METHODS
  A total of 447 patients from 55 European centers who completed a 14-day screening and 14-day run-in phase, received randomized double-blind treatment with 5, 10, 20 or 40 mg teneligliptin or placebo once daily, for 24 weeks. 364 patients continued treatment in a 28-week open label extension during which they received teneligliptin 20 mg once daily.
  
  
  RESULTS
  Co-administration of teneligliptin (5 to 40 mg) with metformin demonstrated dose-related and statistically significant reductions in HbA1c after 24 weeks (-0.30 to -0.63% placebo adjusted) of double-blind treatment. The greatest reduction in HbA1c was seen with teneligliptin at 40 mg (-0.63%) at Week 24. There was also a dose-dependent increase in proportion of responders achieving HbA1c < 7.0% at this endpoint. Responses were maintained throughout 28 weeks open label treatment with 20 mg teneligliptin. Treatment was well tolerated to Week 52 and the overall incidence of hypoglycemia during 52 weeks was 2.3%.
  
  
  CONCLUSIONS
  Teneligliptin co-administered with metformin produced significant reductions in HbA1c in patients with T2DM without increasing the risk of hypoglycemia.
authors.affiliation: a Clinical Department , Mitsubishi Tanabe Pharma Europe Ltd , London , UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bryson
authors.affiliation: b Center for Diabetes and Endocrinology , York Teaching Hospital NHS Foundation Trust Ringgold , York , UK.
authors.forename: Paul E
authors.initials: PE
authors.lastname: Jennings
authors.affiliation: c Department of Internal Medicine , Kaposi Mor County Hospital , Kaposvar , Hungary.
authors.forename: Laszlo
authors.initials: L
authors.lastname: Deak
authors.affiliation: d Department of Nutrition and Endocrinology , Societatea Civila Medicala , Bucharest , Romania.
authors.forename: Fraga S
authors.initials: FS
authors.lastname: Paveliu
authors.affiliation: a Clinical Department , Mitsubishi Tanabe Pharma Europe Ltd , London , UK.
authors.forename: Matt
authors.initials: M
authors.lastname: Lawson
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D008875:Middle Aged; D011720:Pyrazoles / Q000627:therapeutic use*; D053778:Thiazolidines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D011720:Pyrazoles; D053778:Thiazolidines; C579035:3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
keywords: Co-administration; diabetes mellitus; metformin; teneligliptin; type 2