Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study
Objective: Women with insulin-requiring gestational diabetes mellitus (GDM) are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reduc...
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| Format: | Article |
| Language: | English |
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Elsevier
2018-03-01
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| Series: | Molecular Metabolism |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2212877817309493 |
| _version_ | 1819036892148006912 |
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| author | Sandra Hummel Andreas Beyerlein Markus Pfirrmann Anna Hofelich Daniela Much Susanne Hivner Melanie Bunk Melanie Herbst Claudia Peplow Markus Walter Denise Kohn Nadine Hummel Jürgen Kratzsch Michael Hummel Martin Füchtenbusch Joerg Hasford Anette-G. Ziegler Markus Walter Heike Börschmann Sophia Ebe Eleni Giannopoulou Minna Harsunen Veronika Hofbauer Anna Hofelich Andrea Schuppenies Maike Wallner David Wiesenäcker Stephanie Zillmer Melanie Bunk Melanie Herbst Susanne Hivner Lorenz Lachmann Daniela Much Claudia Peplow Joerg Hasford Markus Pfirrmann Rüdiger Landgraf Karl-Theo Maria Schneider Elisabeth André Viktoria Janke Andreas Beyerlein Sandra Hummel Ezio Bonifacio Martin Füchtenbusch Michael Hummel Denise Kohn |
| author_facet | Sandra Hummel Andreas Beyerlein Markus Pfirrmann Anna Hofelich Daniela Much Susanne Hivner Melanie Bunk Melanie Herbst Claudia Peplow Markus Walter Denise Kohn Nadine Hummel Jürgen Kratzsch Michael Hummel Martin Füchtenbusch Joerg Hasford Anette-G. Ziegler Markus Walter Heike Börschmann Sophia Ebe Eleni Giannopoulou Minna Harsunen Veronika Hofbauer Anna Hofelich Andrea Schuppenies Maike Wallner David Wiesenäcker Stephanie Zillmer Melanie Bunk Melanie Herbst Susanne Hivner Lorenz Lachmann Daniela Much Claudia Peplow Joerg Hasford Markus Pfirrmann Rüdiger Landgraf Karl-Theo Maria Schneider Elisabeth André Viktoria Janke Andreas Beyerlein Sandra Hummel Ezio Bonifacio Martin Füchtenbusch Michael Hummel Denise Kohn |
| author_sort | Sandra Hummel |
| collection | DOAJ |
| description | Objective: Women with insulin-requiring gestational diabetes mellitus (GDM) are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reducing the risk of postpartum diabetes. Methods: Women with insulin-requiring GDM were randomized to either placebo or 50 mg vildagliptin twice daily for 24 months followed by a 12-month observation period (EudraCT: 2007-000634-39). Both groups received lifestyle counseling. The primary efficacy outcomes were the diagnosis of diabetes (American Diabetes Association (ADA) criteria) or impaired fasting glucose (IFG)/impaired glucose tolerance (IGT). Results: Between 2008 and 2015, 113 patients (58 vildagliptin, 55 placebo) were randomized within 2.2–10.4 (median 8.6) months after delivery. At the interim analysis, nine diabetic events and 28 IFG/IGT events had occurred. Fifty-two women withdrew before completing the treatment phase. Because of the low diabetes rate, the study was terminated. Lifestyle adherence was similar in both groups. At 24 months, the cumulative probability of postpartum diabetes was 3% and 5% (hazard ratio: 1.03; 95% confidence interval: 0.15–7.36) and IFG/IGT was 43% and 22% (hazard ratio: 0.55; 95% confidence interval: 0.26–1.19) in the placebo and vildagliptin groups, respectively. Vildagliptin was well tolerated with no unexpected adverse events. Conclusions: The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes. However, treatment was safe and suggested some improvements in glycemic control, insulin resistance, and β-cell function. The study identified critical issues in performing clinical trials in the early postpartum period in women with GDM hampering efficacy assessments. With this knowledge, we have set a basis for which properly powered trials could be performed in women with recent GDM. Trial registration number at ClinicalTrials.gov: NCT01018602. Keywords: Gestational diabetes mellitus, Prevention, Dipeptidyl peptidase-4 inhibitor, Postpartum diabetes, Randomized controlled trial, Life-style |
| first_indexed | 2024-12-21T08:12:44Z |
| format | Article |
| id | doaj.art-635c2bfed81846888df968d30e3d0269 |
| institution | Directory Open Access Journal |
| issn | 2212-8778 |
| language | English |
| last_indexed | 2024-12-21T08:12:44Z |
| publishDate | 2018-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Molecular Metabolism |
| spelling | doaj.art-635c2bfed81846888df968d30e3d02692022-12-21T19:10:37ZengElsevierMolecular Metabolism2212-87782018-03-019168175Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled studySandra Hummel0Andreas Beyerlein1Markus Pfirrmann2Anna Hofelich3Daniela Much4Susanne Hivner5Melanie Bunk6Melanie Herbst7Claudia Peplow8Markus Walter9Denise Kohn10Nadine Hummel11Jürgen Kratzsch12Michael Hummel13Martin Füchtenbusch14Joerg Hasford15Anette-G. Ziegler16Markus WalterHeike BörschmannSophia EbeEleni GiannopoulouMinna HarsunenVeronika HofbauerAnna HofelichAndrea SchuppeniesMaike WallnerDavid WiesenäckerStephanie ZillmerMelanie BunkMelanie HerbstSusanne HivnerLorenz LachmannDaniela MuchClaudia PeplowJoerg HasfordMarkus PfirrmannRüdiger LandgrafKarl-Theo Maria SchneiderElisabeth AndréViktoria JankeAndreas BeyerleinSandra HummelEzio BonifacioMartin FüchtenbuschMichael HummelDenise KohnForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyInstitute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyInstitut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians University Munich, Marchioninistr. 15, 81377 München, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyInstitut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians University Munich, Marchioninistr. 15, 81377 München, GermanyInstitute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyInstitut für Laboratoriumsmedizin, Klinische Chemie und Molekulare Diagnostik, Uniklinikum Leipzig, Paul-List-Str. 13/15, 04103 Leipzig, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, GermanyInstitut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians University Munich, Marchioninistr. 15, 81377 München, GermanyForschergruppe Diabetes e.V. am Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Institute of Diabetes Research, Helmholtz Zentrum München, and Forschergruppe Diabetes, Klinikum rechts der Isar, Technische Universität München, Ingolstädter Landstr. 1, 85764 Neuherberg, Germany; Corresponding author. Forschergruppe Diabetes e.V, Ingolstädter Landstraße 1, 85764 Neuherberg, Germany. Fax: +49 89 3187 3144.Objective: Women with insulin-requiring gestational diabetes mellitus (GDM) are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reducing the risk of postpartum diabetes. Methods: Women with insulin-requiring GDM were randomized to either placebo or 50 mg vildagliptin twice daily for 24 months followed by a 12-month observation period (EudraCT: 2007-000634-39). Both groups received lifestyle counseling. The primary efficacy outcomes were the diagnosis of diabetes (American Diabetes Association (ADA) criteria) or impaired fasting glucose (IFG)/impaired glucose tolerance (IGT). Results: Between 2008 and 2015, 113 patients (58 vildagliptin, 55 placebo) were randomized within 2.2–10.4 (median 8.6) months after delivery. At the interim analysis, nine diabetic events and 28 IFG/IGT events had occurred. Fifty-two women withdrew before completing the treatment phase. Because of the low diabetes rate, the study was terminated. Lifestyle adherence was similar in both groups. At 24 months, the cumulative probability of postpartum diabetes was 3% and 5% (hazard ratio: 1.03; 95% confidence interval: 0.15–7.36) and IFG/IGT was 43% and 22% (hazard ratio: 0.55; 95% confidence interval: 0.26–1.19) in the placebo and vildagliptin groups, respectively. Vildagliptin was well tolerated with no unexpected adverse events. Conclusions: The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes. However, treatment was safe and suggested some improvements in glycemic control, insulin resistance, and β-cell function. The study identified critical issues in performing clinical trials in the early postpartum period in women with GDM hampering efficacy assessments. With this knowledge, we have set a basis for which properly powered trials could be performed in women with recent GDM. Trial registration number at ClinicalTrials.gov: NCT01018602. Keywords: Gestational diabetes mellitus, Prevention, Dipeptidyl peptidase-4 inhibitor, Postpartum diabetes, Randomized controlled trial, Life-stylehttp://www.sciencedirect.com/science/article/pii/S2212877817309493 |
| spellingShingle | Sandra Hummel Andreas Beyerlein Markus Pfirrmann Anna Hofelich Daniela Much Susanne Hivner Melanie Bunk Melanie Herbst Claudia Peplow Markus Walter Denise Kohn Nadine Hummel Jürgen Kratzsch Michael Hummel Martin Füchtenbusch Joerg Hasford Anette-G. Ziegler Markus Walter Heike Börschmann Sophia Ebe Eleni Giannopoulou Minna Harsunen Veronika Hofbauer Anna Hofelich Andrea Schuppenies Maike Wallner David Wiesenäcker Stephanie Zillmer Melanie Bunk Melanie Herbst Susanne Hivner Lorenz Lachmann Daniela Much Claudia Peplow Joerg Hasford Markus Pfirrmann Rüdiger Landgraf Karl-Theo Maria Schneider Elisabeth André Viktoria Janke Andreas Beyerlein Sandra Hummel Ezio Bonifacio Martin Füchtenbusch Michael Hummel Denise Kohn Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study Molecular Metabolism |
| title | Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study |
| title_full | Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study |
| title_fullStr | Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study |
| title_full_unstemmed | Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study |
| title_short | Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study |
| title_sort | efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin requiring gestational diabetes a phase ii randomized double blind placebo controlled study |
| url | http://www.sciencedirect.com/science/article/pii/S2212877817309493 |
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