Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial
Summary 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 (HbA1c) >...
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| Published in | International journal of clinical practice (Esher) Vol. 64; no. 12; pp. 1619 - 1631 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.11.2010
Wiley-Blackwell Hindawi Limited Wiley |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Summary
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 (HbA1c) > 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 HbA1c 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 HbA1c 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 HbA1c (%/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 (∼4%).
Conclusion: Saxagliptin plus metformin was well tolerated, provided a sustained HbA1c reduction over 52 weeks, and was non‐inferior to glipizide plus metformin, with reduced body weight and a significantly lower risk of hypoglycaemia. |
|---|---|
| AbstractList | Summary
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 (HbA1c) > 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 HbA1c 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 HbA1c 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 HbA1c (%/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 (∼4%).
Conclusion: Saxagliptin plus metformin was well tolerated, provided a sustained HbA1c reduction over 52 weeks, and was non‐inferior to glipizide plus metformin, with reduced body weight and a significantly lower risk of hypoglycaemia. AIMTo 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 PATIENTSA 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.RESULTSThe 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 (∼4%).CONCLUSIONSaxagliptin 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. 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 glycemic control on metformin alone. Methods and patients: A total of 858 patients [age ≥18years; glycated hemoglobin (HbA1c) >6.5-10.0%; on stable metformin doses ≥1500mg/day] were randomized 1:1 to saxagliptin 5mg/day or glipizide up-titrated as needed from 5 to 20mg/day for 52weeks. The primary objective was to assess if the change from baseline HbA1c 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 HbA1c 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 hypoglycemic events (3.0% vs. 36.3%; p<0.0001) and a divergent impact on body weight (adjusted mean change from baseline -1.1kg with saxagliptin vs. 1.1kg with glipizide; p<0.0001). There was a significantly smaller rise in HbA1c(%/week) from week 24 to 52 with saxagliptin vs. glipizide (0.001% vs. 0.004%; p=0.04) indicating a sustained glycemic effect beyond week 24. Excluding hypoglycemic 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 hypoglycemia in glipizide patients. Discontinuation rates resulting from AEs were similar (4%). Conclusion: Saxagliptin plus metformin was well tolerated, provided a sustained HbA1c reduction over 52weeks, and was non-inferior to glipizide plus metformin, with reduced body weight and a significantly lower risk of hypoglycemia. [PUBLICATION ABSTRACT] 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. 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. 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 (∼4%). 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. Aim: 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 [HbA1c] >6.5–10.0%; on stable metformin doses ≥1500mg/day) were randomised 1:1 to saxagliptin 5mg/day or glipizide up-titrated as needed from 5–20mg/day for 52 weeks. The primary objective was to assess if the change from baseline HbA1c 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 HbA1c 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 significantly fewer 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 –1.1kg with saxagliptin vs. 1.1kg with glipizide; p<0.0001). There was a significantly smaller rise in HbA1c (%/wk) 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 due to AEs were similar (~4%). Conclusion: Saxagliptin plus metformin provided a sustained HbA1c reduction over 52 weeks and was non-inferior to glipizide plus metformin, with reduced body weight and significantly lower risk of hypoglycaemia. |
| Author | Gause-Nilsson, I. Göke, B. Hellqvist, Å. Eriksson, J. Gallwitz, B. |
| Author_xml | – sequence: 1 givenname: B. surname: Göke fullname: Göke, B. organization: Hospital of the Ludwig Maximilian, University of Munich, Munich, Germany – sequence: 2 givenname: B. surname: Gallwitz fullname: Gallwitz, B. organization: Klinikum der Eberhard-Karls-Universität Tübingen Medizinische Klinik, Tübingen, Germany – sequence: 3 givenname: J. surname: Eriksson fullname: Eriksson, J. organization: Helsinki University Central Hospital, Unit of General Practice and University of Helsinki, Helsinki, Finland – sequence: 4 givenname: Å. surname: Hellqvist fullname: Hellqvist, Å. organization: AstraZeneca Research & Development, Mölndal, Sweden – sequence: 5 givenname: I. surname: Gause-Nilsson fullname: Gause-Nilsson, I. organization: AstraZeneca Research & Development, Mölndal, Sweden |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23292926$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/20846286$$D View this record in MEDLINE/PubMed https://hal.science/hal-00577009$$DView record in HAL |
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| ContentType | Journal Article |
| Contributor | Angus, M Gronert, J Mishra, A Hoye, K Gurzó, M Kallioniemi, V Kurl, S Litchfield, J Wachter, J Hellsten, T Preusche, A Chung, C H Kosch, C Veerman, W De Vos, R Park, I B Kiesilä, J Gibson, M Knoph, E Shah, S Coenen, P Forst, T Jain, S Brown, V Dudás, M Takács, J Kerekes, C Ferguson, H Mészáros, J Mindt-Prüfert, S Dezso, E Park, S W Orlowski, M Schilder, A Rani, P U Gudnason, S Tamás, G Simpson, J Bantwal, G Siren, R Langan, J Madsbu, S Matsi, P Johansen, R Tervo, J Wyatt, N V Van Mierlo, H Reiber, I Bodalia, B Hamilton, L Kerényi, Z Bots, A Rol, H Langaker, K Winkelmann, B Bonarius, J H Bierens, I Petró, G Lee, H C Langslet, G Risberg, K Caldwell, I Keiran, W J G Sehnert, W Kjørlaug, K O Poór, F Elle, S Eriksson, J Boermans, T Kanniess, F Butler, M Klausmann, G Gupta, J De Backer, W Lønning, S A Pieters, R Nam, M S Menne, J Schulze, E D Black, D A Gallwitz, B Leeuwen, P V Retterstøl, K Baik, S H Korányi, L Gyimesi, A Lacner, B Frick, H King, B Kim, Y S Möckesch, B Skjegstad, E Páll, K Block, T Thompson, J Høivik, H O Strand, J Brunstad, O Hopsu, J Ladányi, E |
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| Copyright | 2010 Blackwell Publishing Ltd 2015 INIST-CNRS 2010 Blackwell Publishing Ltd. Distributed under a Creative Commons Attribution 4.0 International License |
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| Keywords | Dipeptidyl-peptidase IV Endocrinopathy Type 2 diabetes Human Enzyme Enzyme inhibitor Metabolic diseases Patient Glipizide Randomized controlled trial Medicine Peptidases Hypoglycemic agent Biguanides Sulfonamides Gliptine derivatives Sulfonylureas Hydrolases Dipeptidyl-peptidase IV inhibitor Clinical trial Metformin Saxagliptin |
| Language | English |
| License | CC BY 4.0 2010 Blackwell Publishing Ltd. Distributed under a Creative Commons Attribution 4.0 International License: http://creativecommons.org/licenses/by/4.0 |
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| Notes | ArticleID:IJCP2510 ark:/67375/WNG-7H8W74L9-2 istex:691609786C5316CBD911345671F4BA546829721A Disclosures The D1680C00001 Investigators are listed in the Dr Göke declares that he has served on an advisory board for AstraZeneca and received honoraria for speaking engagements with AstraZeneca, Eli Lilly and Company, Novartis and Novo Nordisk. Dr Gallwitz has served on advisory boards for AstraZeneca, Bristol‐Myers Squibb, Boehringer Ingelheim, Eli Lilly and Company, Novartis, Novo Nordisk, Merck & Co., Inc., Hoffman‐La Roche Inc., and Takeda Pharmaceutical, and received honoraria for speaking engagements from these companies. Dr Eriksson has been an investigator or received honoraria for speaking engagements with AstraZeneca, Bristol‐Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Novartis, Novo Nordisk, Hoffman‐La Roche Inc., and sanofi‐aventis. Åsa Hellqvist, MSc and Dr Gause‐Nilsson are employees of AstraZeneca Research & Development. Appendix . ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-News-2 ObjectType-Feature-3 content type line 23 |
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| PublicationDate | November 2010 |
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| PublicationTitle | International journal of clinical practice (Esher) |
| PublicationTitleAlternate | Int J Clin Pract |
| PublicationYear | 2010 |
| Publisher | Blackwell Publishing Ltd Wiley-Blackwell Hindawi Limited Wiley |
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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... 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... 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... AIMTo assess the efficacy and safety of saxagliptin vs. glipizide as add-on therapy to metformin in patients with type 2 diabetes mellitus and inadequate... Aim: Assess the efficacy and safety of saxagliptin vs. glipizide, as add-on therapy to metformin in patients with type 2 diabetes mellitus and inadequate... |
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| SubjectTerms | Adamantane - administration & dosage Adamantane - adverse effects Adamantane - analogs & derivatives Aged Biological and medical sciences Blood Glucose Clinical trials Diabetes Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Diabetes. Impaired glucose tolerance Dipeptides - administration & dosage Dipeptides - adverse effects Dipeptidyl-Peptidase IV Inhibitors - administration & dosage Dipeptidyl-Peptidase IV Inhibitors - adverse effects Double-Blind Method Drug therapy Drug Therapy, Combination Endocrine pancreas. Apud cells (diseases) Endocrinopathies Etiopathogenesis. Screening. Investigations. Target tissue resistance Female General aspects Glipizide - administration & dosage Glipizide - adverse effects Glycated Hemoglobin A - metabolism Humans Hypoglycemia Hypoglycemia - prevention & control Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Male Medical sciences Metformin - administration & dosage Metformin - adverse effects Middle Aged Treatment Outcome |
| Title | Saxagliptin is non-inferior to glipizide in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: a 52-week randomised controlled trial |
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