PMID- 20846286 OWN - NLM STAT- MEDLINE DCOM- 20111128 LR - 20221207 IS - 1742-1241 (Electronic) IS - 1368-5031 (Linking) VI - 64 IP - 12 DP - 2010 Nov TI - Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial. PG - 1619-31 LID - 10.1111/j.1742-1241.2010.02510.x [doi] AB - AIM: To assess the efficacy and safety of saxagliptin vs. glipizide as add-on therapy to metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control on metformin alone. METHODS AND PATIENTS: A total of 858 patients [age >/= 18 years; glycated haemoglobin (HbA(1c) ) > 6.5 - 10.0%; on stable metformin doses >/= 1500 mg/day] were randomised 1 : 1 to saxagliptin 5 mg/day or glipizide up-titrated as needed from 5 to 20 mg/day for 52 weeks. The primary objective was to assess if the change from baseline HbA(1c) achieved with saxagliptin plus metformin was non-inferior to glipizide plus metformin. RESULTS: The per-protocol analysis demonstrated non-inferiority of saxagliptin vs. glipizide; adjusted mean changes from baseline HbA(1c) were -0.74% vs. -0.80%, respectively; the between-group difference was 0.06% (95% CI, -0.05% to 0.16%). Treatment with saxagliptin vs. glipizide was associated with a significantly smaller proportion of patients with hypoglycaemic events (3.0% vs. 36.3%; p < 0.0001) and a divergent impact on body weight (adjusted mean change from baseline -1.1 kg with saxagliptin vs. 1.1 kg with glipizide; p < 0.0001). There was a significantly smaller rise in HbA(1c) (%/week) from week 24 to 52 with saxagliptin vs. glipizide (0.001% vs. 0.004%; p = 0.04) indicating a sustained glycaemic effect beyond week 24. Excluding hypoglycaemic events, the proportion of patients experiencing adverse events (AEs) was similar (60.0% saxagliptin vs. 56.7% glipizide); treatment-related AEs were less common with saxagliptin vs. glipizide (9.8% vs. 31.2%), attributable to the higher frequency of hypoglycaemia in glipizide patients. Discontinuation rates resulting from AEs were similar ( approximately 4%). CONCLUSION: Saxagliptin plus metformin was well tolerated, provided a sustained HbA(1c) reduction over 52 weeks, and was non-inferior to glipizide plus metformin, with reduced body weight and a significantly lower risk of hypoglycaemia. CI - (c) 2010 Blackwell Publishing Ltd. FAU - Goke, B AU - Goke B AD - Hospital of the Ludwig Maximilian, University of Munich, Munich, Germany. FAU - Gallwitz, B AU - Gallwitz B FAU - Eriksson, J AU - Eriksson J FAU - Hellqvist, A AU - Hellqvist A FAU - Gause-Nilsson, I AU - Gause-Nilsson I CN - D1680C00001 Investigators LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20100916 PL - India TA - Int J Clin Pract JT - International journal of clinical practice JID - 9712381 RN - 0 (Blood Glucose) RN - 0 (Dipeptides) RN - 0 (Dipeptidyl-Peptidase IV Inhibitors) RN - 0 (Glycated Hemoglobin A) RN - 0 (Hypoglycemic Agents) RN - 9100L32L2N (Metformin) RN - 9GB927LAJW (saxagliptin) RN - PJY633525U (Adamantane) RN - X7WDT95N5C (Glipizide) SB - IM MH - Adamantane/administration & dosage/adverse effects/*analogs & derivatives MH - Aged MH - Blood Glucose MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Dipeptides/*administration & dosage/adverse effects MH - Dipeptidyl-Peptidase IV Inhibitors/*administration & dosage/adverse effects MH - Double-Blind Method MH - Drug Therapy, Combination MH - Female MH - Glipizide/*administration & dosage/adverse effects MH - Glycated Hemoglobin/metabolism MH - Humans MH - Hypoglycemia/prevention & control MH - Hypoglycemic Agents/*administration & dosage/adverse effects MH - Male MH - Metformin/*administration & dosage/adverse effects MH - Middle Aged MH - Treatment Outcome FIR - Eriksson, J IR - Eriksson J FIR - Hellsten, T IR - Hellsten T FIR - Hopsu, J IR - Hopsu J FIR - Kallioniemi, V IR - Kallioniemi V FIR - Kiesila, J IR - Kiesila J FIR - Kurl, S IR - Kurl S FIR - Matsi, P IR - Matsi P FIR - Siren, R IR - Siren R FIR - Strand, J IR - Strand J FIR - Tervo, J IR - Tervo J FIR - Block, T IR - Block T FIR - Forst, T IR - Forst T FIR - Frick, H IR - Frick H FIR - Gallwitz, B IR - Gallwitz B FIR - Kanniess, F IR - Kanniess F FIR - Klausmann, G IR - Klausmann G FIR - Kosch, C IR - Kosch C FIR - Lacner, B IR - Lacner B FIR - Menne, J IR - Menne J FIR - Mindt-Prufert, S IR - Mindt-Prufert S FIR - Mockesch, B IR - Mockesch B FIR - Orlowski, M IR - Orlowski M FIR - Preusche, A IR - Preusche A FIR - Schulze, E D IR - Schulze ED FIR - Sehnert, W IR - Sehnert W FIR - Wachter, J IR - Wachter J FIR - Winkelmann, B IR - Winkelmann B FIR - Angus, M IR - Angus M FIR - Black, D A IR - Black DA FIR - Bodalia, B IR - Bodalia B FIR - Brown, V IR - Brown V FIR - Butler, M IR - Butler M FIR - Caldwell, I IR - Caldwell I FIR - Gibson, M IR - Gibson M FIR - Hamilton, L IR - Hamilton L FIR - Keiran, W J G IR - Keiran WJ FIR - King, B IR - King B FIR - Langan, J IR - Langan J FIR - Litchfield, J IR - Litchfield J FIR - Mishra, A IR - Mishra A FIR - Pieters, R IR - Pieters R FIR - Simpson, J IR - Simpson J FIR - Thompson, J IR - Thompson J FIR - Wyatt, N V IR - Wyatt NV FIR - Dezso, E IR - Dezso E FIR - Dudas, M IR - Dudas M FIR - Gurzo, M IR - Gurzo M FIR - Gyimesi, A IR - Gyimesi A FIR - Kerekes, C IR - Kerekes C FIR - Kerenyi, Z IR - Kerenyi Z FIR - Koranyi, L IR - Koranyi L FIR - Ladanyi, E IR - Ladanyi E FIR - Meszaros, J IR - Meszaros J FIR - Pall, K IR - Pall K FIR - Petro, G IR - Petro G FIR - Poor, F IR - Poor F FIR - Reiber, I IR - Reiber I FIR - Takacs, J IR - Takacs J FIR - Tamas, G IR - Tamas G FIR - Bantwal, G IR - Bantwal G FIR - Gupta, J IR - Gupta J FIR - Jain, S IR - Jain S FIR - Rani, P U IR - Rani PU FIR - Shah, S IR - Shah S FIR - Bierens, I IR - Bierens I FIR - Boermans, T IR - Boermans T FIR - Bonarius, J H IR - Bonarius JH FIR - Bots, A IR - Bots A FIR - Coenen, P IR - Coenen P FIR - De Backer, W IR - De Backer W FIR - De Vos, R IR - De Vos R FIR - Ferguson, H IR - Ferguson H FIR - Leeuwen, P V IR - Leeuwen PV FIR - Rol, H IR - Rol H FIR - Schilder, A IR - Schilder A FIR - Van Mierlo, H IR - Van Mierlo H FIR - Veerman, W IR - Veerman W FIR - Brunstad, O IR - Brunstad O FIR - Elle, S IR - Elle S FIR - Gronert, J IR - Gronert J FIR - Gudnason, S IR - Gudnason S FIR - Hoivik, H O IR - Hoivik HO FIR - Hoye, K IR - Hoye K FIR - Johansen, R IR - Johansen R FIR - Kjorlaug, K O IR - Kjorlaug KO FIR - Knoph, E IR - Knoph E FIR - Langaker, K IR - Langaker K FIR - Langslet, G IR - Langslet G FIR - Lonning, S A IR - Lonning SA FIR - Madsbu, S IR - Madsbu S FIR - Retterstol, K IR - Retterstol K FIR - Risberg, K IR - Risberg K FIR - Skjegstad, E IR - Skjegstad E FIR - Baik, S H IR - Baik SH FIR - Chung, C H IR - Chung CH FIR - Kim, Y S IR - Kim YS FIR - Lee, H C IR - Lee HC FIR - Nam, M S IR - Nam MS FIR - Park, I B IR - Park IB FIR - Park, S W IR - Park SW FIR - Park, Y S IR - Park YS FIR - Son, H S IR - Son HS FIR - Antsiferov, M IR - Antsiferov M FIR - Arutyunov, G IR - Arutyunov G FIR - Chazova, I IR - Chazova I FIR - Dreval, A IR - Dreval A FIR - Galyavich, A IR - Galyavich A FIR - Grineva, E IR - Grineva E FIR - Karpova, I IR - Karpova I FIR - Khokhlov, A IR - Khokhlov A FIR - Kisliak, O IR - Kisliak O FIR - Kobalava, Z IR - Kobalava Z FIR - Kotova, S IR - Kotova S FIR - Krasilnikova, E IR - Krasilnikova E FIR - Kukharchuk, V IR - Kukharchuk V FIR - Lantseva, O IR - Lantseva O FIR - Libov, I IR - Libov I FIR - Neberidze, D IR - Neberidze D FIR - Nosova, N IR - Nosova N FIR - Pavlova, M IR - Pavlova M FIR - Privalov, D IR - Privalov D FIR - Shustov, S IR - Shustov S FIR - Sivkova, E IR - Sivkova E FIR - Strongin, L IR - Strongin L FIR - Tereschenko, S IR - Tereschenko S FIR - Vorokhobina, N IR - Vorokhobina N FIR - Voychik, E IR - Voychik E FIR - Zalevskaya, A IR - Zalevskaya A FIR - Zhelninova, T IR - Zhelninova T FIR - Buganova, I IR - Buganova I FIR - Fedurcova, E IR - Fedurcova E FIR - Kuderova, D IR - Kuderova D FIR - Kurcova, I IR - Kurcova I FIR - Minarovicova, O IR - Minarovicova O FIR - Rociakova, J IR - Rociakova J FIR - Schroner, Z IR - Schroner Z FIR - Strba, J IR - Strba J FIR - Truban, J IR - Truban J FIR - Dao, N T B IR - Dao NT FIR - Khue, N T IR - Khue NT EDAT- 2010/09/18 06:00 MHDA- 2011/12/13 00:00 CRDT- 2010/09/18 06:00 PHST- 2010/09/18 06:00 [entrez] PHST- 2010/09/18 06:00 [pubmed] PHST- 2011/12/13 00:00 [medline] AID - 10.1111/j.1742-1241.2010.02510.x [doi] PST - ppublish SO - Int J Clin Pract. 2010 Nov;64(12):1619-31. doi: 10.1111/j.1742-1241.2010.02510.x. Epub 2010 Sep 16.