Cited by 308Diabetes Treatment and ManagementDiabetes Management and ResearchPeptidase Inhibition and Analysis

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Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus

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Richter, Bernd, Bandeira-Echtler, Elizabeth, Bergerhoff, Karla, Lerch, Christian·2008·Cochrane Database of Systematic Reviews

DOI 10.1002/14651858.cd006739.pub2PMC PMC8985075

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Abstract

BACKGROUND: In type 2 diabetes mellitus there is a progressive loss of beta-cell function. One new approach yielding promising results is the use of the orally active dipeptidyl peptidase-4 (DPP-4) inhibitors like sitagliptin and vildagliptin. OBJECTIVES: To assess the effects of dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. SEARCH STRATEGY: Studies were obtained from computerised searches of MEDLINE, EMBASE and The Cochrane Library. SELECTION CRITERIA: Studies were included if they were randomised controlled trials in adult people with type 2 diabetes mellitus and had a trial duration of at least 12 weeks. DATA COLLECTION AND ANALYSIS: Two authors independently assessed risk of bias and extracted data. Pooling of studies was performed by means of fixed-effect meta-analysis. MAIN RESULTS: Twenty-five studies of good quality were identified, 11 trials evaluated sitagliptin and 14 trials vildagliptin treatment. Altogether, 6743 patients were randomised in sitagliptin and 6121 patients in vildagliptin studies, respectively. Sitagliptin and vildagliptin studies ranged from 12 to 52 weeks duration. No data were published on mortality, diabetic complications, costs of treatment and health-related quality of life. Sitagliptin and vildagliptin therapy in comparison with placebo resulted in an HbA1c reduction of approximately 0.7% and 0.6%, respectively. Data on comparisons with active comparators were limited but indicated no improved metabolic control following DPP-4 intervention in contrast to other hypoglycaemic agents. Sitagliptin and vildagliptin therapy did not result in weight gain but weight loss was more pronounced following placebo interventions. No definite conclusions could be drawn from published data on sitagliptin and vildagliptin effects on measurements of beta-cell function. Overall, sitagliptin and vildagliptin were well tolerated, no severe hypoglycaemia was reported in patients taking sitagliptin or vildagliptin. All-cause infections increased significantly after sitagliptin treatment but did not reach statistical significance following vildagliptin therapy. All published randomised controlled trials of at least 12 weeks treatment with sitagliptin and vildagliptin only reported routine laboratory safety measurements AUTHORS' CONCLUSIONS: DPP-4 inhibitors have some theoretical advantages over existing therapies with oral antidiabetic compounds but should currently be restricted to individual patients. Long-term data especially on cardiovascular outcomes and safety are urgently needed before widespread use of these new agents. More information on the benefit-risk ratio of DPP-4 inhibitor treatment is necessary especially analysing adverse effects on parameters of immune function. Also, long-term data are needed investigating patient-oriented parameters like health-related quality of life, diabetic complications and all-cause mortality.

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“Infections, including nasopharyngitis, have been reported more commonly with sitagliptin than with vildagliptin, the relevance of which is yet unknown [72].”
BackgroundInfluential
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“Safety outcomes extracted included withdrawal rates from any adverse events that documented incidence of hypoglycemia, nausea, vomiting, diarrhea, constipation, urinary tract infection (UTI), upper respiratory infection (URTI), nasopharyngitis, and headache based on their clinical relevance or relatively high frequenc…”
Background
Identifying neuropeptide Y (NPY) as the main stress-related substrate of dipeptidyl peptidase 4 (DPP4) in blood circulation
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“Up to date 125 meta-analyses have been reported in PubMed, focusing on the efficacy, drug safety of DPP4 inhibitors as well as its effects on comorbidities such as renal impairment and cardiovascular outcome (Schuetz et al., 2015; Cheng et al., 2014; Richter et al., 2008; Tricco et al., 2014; Baetta and Corsini, 2011;…”
Background
Confronting the Type 2 Diabetes Epidemic: the Emerging Role of Incretin-Based Therapies
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Tricco, A. C., Antony, J., Khan, P. A., Ghassemi, M., Hamid, J. S., Ashoor, H. M., Blondal, E., Soobiah, C., Yu, C. H. Y., Hutton, B., et al. (2014) · BMJ Open · doi:10.1136/bmjopen-2014-005752 · Cited by 36
“The first two reviews did not examine infections,(7) 8 yet a Cochrane review found significantly increased infections for sitagliptin but not for vildagliptin.(35) This Cochrane review examined DPP-4 inhibitors for any patient with T2DM, whereas we focused on those failing two oral antihyperglycaemic”
Background
Treatment of type 2 diabetes with incretin-based therapies
Madsbad, S. (2008) · The Lancet · doi:10.1016/s0140-6736(08)61247-7 · Cited by 35
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“Increased risk of infections, particularly upper respiratory tract infections, had been suggested by initial studies [52-55], more often with sitagliptin [54,56].”
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Emerging therapies in the treatment of ‘diabesity’: beyond GLP-1
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A novel model-based meta-analysis to indirectly estimate the comparative efficacy of two medications: an example using DPP-4 inhibitors, sitagliptin and linagliptin, in treatment of type 2 diabetes mellitus
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“To date, four standard meta-analyses of the DPP-4 inhibitor class have been published, none of which has provided any results on the comparative efficacies of linagliptin and sitagliptin.(16) 53–55 These analyses confirm Figure 3 Drug effects (as glycated haemoglobin (HbA1c) percentage points) of the relevant studies…”
Background
The benefits and risks of DPP 4‐inhibitors vs. sulfonylureas for patients with type 2 diabetes: accumulated evidence from randomised controlled trial
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“Dipeptidyl peptidase-4 (DPP-4) inhibitors are a novel pharmacological class of glucoselowering agents that open new perspectives for the management of type 2 diabetes (T2DM) [1-5].”
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“This is of importance in balancing the risk: benefit ratio for treatment with DPP IV inhibitors [10,11].”
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DPP-4 inhibition with linagliptin ameliorates the progression of premature aging in klotho−/− mice
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“6%, respectively, compared with placebo [5].”
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“Sitagliptin is a highly selective oral dipeptidyl peptidase-4 (DPP IV) inhibitor that inhibits the breakdown of incretins such as glucagon-like peptide-1 and glucosedependent insulinotropic polypeptide (78), which is used as a monotherapy or as a component of combination therapy for the treatment of patients with type…”
Background
Therapeutic Potentials of Colocasia affinis Leaf Extract for the Alleviation of Streptozotocin-Induced Diabetes and Diabetic Complications: In vivo and in silico-Based Studies
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“Systematic reviews and meta-analyses performed in people with type 2 diabetes treated with DPP-4 inhibitors reported similar findings.(72,73)”
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Dipeptidyl peptidase-4 inhibitors in the management of type 2 diabetes: safety, tolerability, and efficacy
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Method
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Short-term dipeptidyl peptidase-4 inhibitor use increases the risk of herpes zoster infection in Asian patients with diabetes
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Sitagliptin treatment of patients with type 2 diabetes does not affect CD4+ T-cell activation
White, P. C., Shea, H. C., & de la Morena, M. T. (2009) · Journal of Diabetes and its Complications · doi:10.1016/j.jdiacomp.2009.09.001 · Cited by 16
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“These peptides are members of the glucagon peptide superfamily that helps the body produce more insulin when it is needed [1,7-11].”
Background
Virtual Screening, Synthesis, and Biological Evaluation of Some Carbohydrazide Derivatives as Potential DPP-IV Inhibitors
Jadhav, P. B., Jadhav, S. B., Zehravi, M., Mubarak, M. S., Islam, F., Jeandet, P., Khan, S. L., Hossain, N., Rashid, S., Ming, L. C., et al. (2022) · Molecules · doi:10.3390/molecules28010149 · Cited by 15
“In the latter stages of type 2 diabetes, DPPIV inhibitors are also indicated in the recommendations as part of triple treatments with metformin and SGLT-2 inhibitors or with metformin and insulin [8,9].”
Background
Treating the obese diabetic
Kenkre, J. S., Tan, T., & Bloom, S. R. (2013) · Expert Review of Clinical Pharmacology · doi:10.1586/ecp.13.5 · Cited by 14
Effect of Sitagliptin and Metformin on Prediabetes Progression to Type 2 Diabetes - A Randomized, Double-Blind, Double-Arm, Multicenter Clinical Trial: Protocol for the Sitagliptin and Metformin in PreDiabetes (SiMePreD) Study
Naidoo, P., Wing, J., & Rambiritch, V. (2016) · JMIR Research Protocols · doi:10.2196/resprot.5073 · Cited by 15
“A Cochrane review [47] of DPP-IV inhibitors found that all-cause infections (eg, nasopharyngitis, upper respiratory tract infection, urinary tract infection) showed a statistically significant increase after sitagliptin treatment (risk ratio 1.15, 95% CI 1.02-1.31; P =0.03).”
Influential
Incretins and the intensivist: what are they and what does an intensivist need to know about them?
Plummer, M. P., Chapman, M. J., Horowitz, M., & Deane, A. M. (2014) · Critical Care · doi:10.1186/cc13737 · Cited by 17
“However, a meta-analysis reported a very minor increase in all-cause infection during sitagliptin treatment that was not evident in studies involving other DPP-4 inhibitors [55].”
Result
Post‐transplantation diabetes mellitus: evaluation of treatment strategies
Haidinger, M., Antlanger, M., Kopecky, C., Kovarik, J. J., Säemann, M. D., & Werzowa, J. M. (2015) · Clinical Transplantation · doi:10.1111/ctr.12541 · Cited by 15
“Dipeptidyl peptidase-4 (DPP-4) inhibitors stabilize the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP), resulting in improved metabolic control and reduction of postprandial hyperglycemia (24).”
Background
Differentiating Incretin Therapies Based on Structure Activity, and Metabolism: Focus on Liraglutide
Grossman, S. (2009) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1592/phco.29.pt2.25s · Cited by 15
Management of patients with type 2 diabetes
Nelson, S. E. (2011) · Current Medical Research and Opinion · doi:10.1185/03007995.2011.611797 · Cited by 14
Dipeptidyl peptidase‐4 inhibitors and the risk of community‐acquired pneumonia in patients with type 2 diabetes
Faillie, J.-L., Filion, K. B., Patenaude, V., Ernst, P., & Azoulay, L. (2015) · Diabetes Obesity and Metabolism · doi:10.1111/dom.12431 · Cited by 15
“In addition, a meta-analysis of eight randomized controlled trials found a 29% increased risk of any infection with the DPP-4 inhibitor sitagliptin [9].”
BackgroundMethod
Cost-effectiveness of vildagliptin for people with type 2 diabetes mellitus in Brazil; findings and implications
de Oliveira, G. L. A., Guerra, A. A., Godman, B., & Acúrcio, F. D. A. (2017) · Expert Review of Pharmacoeconomics & Outcomes Research · doi:10.1080/14737167.2017.1292852 · Cited by 14
“Richter et al. (2008), in a systematic review concerning DPP-4 inhibitors for the treatment of T2DM published by Cochrane Collaboration, indicated the urgent need for data about safety and follow-up for long periods to aid decision-making [46].”
DPP-4 inhibitors for the treatment of type 2 diabetes: a methodology overview of systematic reviews
Ling, J., Ge, L., Ding-hua, Z., Wang, Y., Xie, Z.-L., Tian, J., Xiao, X., & Yang, K. (2018) · Acta Diabetologica · doi:10.1007/s00592-018-1164-5 · Cited by 14
Efficacy of mesenchymal stem cell therapy on glucose levels in type 2 diabetes mellitus: A systematic review and meta‐analysis
Ranjbaran, H., Jobani, B. M., Amirfakhrian, E., & Alizadeh‐Navaei, R. (2020) · Journal of Diabetes Investigation · doi:10.1111/jdi.13404 · Cited by 13
DPP-4 Inhibitors and Respiratory Infection: A Systematic Review and Meta-analysis of the Cardiovascular Outcomes Trials
Grenet, G., Mekhaldi, S., Mainbourg, S., Auffret, M., Cornu, C., Cracowski, J., Gueyffier, F., Lega, J., & Cucherat, M. (2021) · Diabetes Care · doi:10.2337/dc20-2018 · Cited by 14
Comparative Effectiveness of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors and Human Glucagon-Like Peptide-1 (GLP-1) Analogue as Add-On Therapies to Sulphonylurea among Diabetes Patients in the Asia-Pacific Region: A Systematic Review
Wong, M. C. S., Wang, H., Kwan, M. W. M., Zhang, D. D. X., Liu, K. Q. L., Chan, S. W. M., Fan, C. K. M., Fong, B. C. Y., Li, S. T. S., & Griffiths, S. M. (2014) · PLoS ONE · doi:10.1371/journal.pone.0090963 · Cited by 16
Management of diabetes across the course of disease: minimizing obesity-associated complications
Apovian, C. M. (2011) · Diabetes Metabolic Syndrome and Obesity · doi:10.2147/dmso.s24022 · Cited by 14
“8% and are generally weight-neutral.(27,63,64) Since these drugs act via increasing the duration of action of GLP-1, they have low risk for hypoglycemia.”
Efficacy and Safety of Sitagliptin in the Treatment of Type 2 Diabetes
Gadsby, R. (2009) · Clinical Medicine Therapeutics · doi:10.4137/cmt.s2313 · Cited by 15
DIPEPTIDYL PEPTIDASE 4 (DPP-4) INHIBITORS FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS
Kristin, E. (2016) · Journal of the Medical Sciences (Berkala Ilmu Kedokteran) · doi:10.19106/jmedsci004802201606 · Cited by 13
Dipeptidyl peptidase IV (DPP4)-deficiency attenuates diet-induced obesity in rats: Possible implications for the hypothalamic neuropeptidergic system
Stephan, M., Radicke, A., Leutloff, S., Schmiedl, A., Pabst, R., von Hörsten, S., Dettmer, S., Lotz, J., & Nave, H. (2010) · Behavioural Brain Research · doi:10.1016/j.bbr.2010.09.024 · Cited by 13
Diabetic Kidney Disease in Post-Transplant Diabetes Mellitus: Causes, Treatment and Outcomes
Lim, L., Chang, J., & Kuo, H. (2023) · Biomedicines · doi:10.3390/biomedicines11020470 · Cited by 12
“Dipeptidyl peptidase 4 inhibitors (DPP4i) are selective inhibitors of DPP4 that have been linked to the degradation of two major incretins, glucagon-like peptide 1 and glucose inhibitory peptide 2 [95].”
Background
Development of Clinically Optimized Sitagliptin and Dapagliflozin Complex Tablets: Pre-Formulation, Formulation, and Human Bioequivalence Studies
Kang, S.-J., & Kim, J.-E. (2023) · Pharmaceutics · doi:10.3390/pharmaceutics15041246 · Cited by 17
“DPP-4 inhibitors do not cause weight gain compared with the impact of a rapid decrease in blood glucagon, and because they act dependently on blood glucagon concentrations in the body, they have a low risk of hypoglycemia and are used as an adjuvant to dietary and exercise therapy [15,16].”
Background
Reshaping Diabetes Care: The Fundamental Role of Dipeptidyl Peptidase-4 Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists in Clinical Practice
Umpierrez, G. E., & Meneghini, L. (2013) · Endocrine Practice · doi:10.4158/ep12292.ra · Cited by 12
Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin up-titration in Chinese patients with type 2 diabetes mellitus: study design and rationale of the vision study
Ji, L., Pan, C., Lu, J., Li, H., Li, Q., Li, Q., Peng, Y., Tian, H., Yao, C., Zhao, Z., et al. (2013) · Cardiovascular Diabetology · doi:10.1186/1475-2840-12-118 · Cited by 12
“Recent reviews of randomized studies of a minimum of 12 weeks’ duration have suggested that DPP-IV inhibitors are well tolerated, with no reports of severe hypoglycemia and weight gain in patients with T2DM [23,24].”
Background
Optimising the medical management of hyperglycaemia in type 2 diabetes in the Middle East: pivotal role of metformin
Al-Maatouq, M. A., Alarouj, M., Assaad, S. H., Assaad, S. N., Azar, S. T., Hassoun, A. A. K., Jarrah, N. S., Zatari, S., & Alberti, K. G. M. M. (2009) · International Journal of Clinical Practice · doi:10.1111/j.1742-1241.2009.02235.x · Cited by 12
Effects of selected antidiabetics on weight loss – A retrospective database analysis
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“Both nfluence the glucagon-like peptide (GLP-1) [8,9], which is an ncretin hormone released into the circulation in response to utrients.”
Background
Insulin initiation in type 2 diabetes: What are the treatment regimen options and how can we best help patients feel empowered?
Spollett, G. R. (2012) · Journal of the American Academy of Nurse Practitioners · doi:10.1111/j.1745-7599.2012.00721.x · Cited by 11
“7% (Richter et al., 2008) and one head-tohead study (Pratley et al.”
BackgroundResultInfluential
What to add in with metformin in type 2 diabetes?
Petrie, J. R., Adler, A., & Vella, S. (2010) · QJM · doi:10.1093/qjmed/hcq237 · Cited by 11
Drug-related risk of severe hypoglycaemia in observational studies: a systematic review and meta-analysis
Czech, M., Rdzanek, E., Pawèska, J., Adamowicz-Sidor, O., Niewada, M., & Jakubczyk, M. (2015) · BMC Endocrine Disorders · doi:10.1186/s12902-015-0052-z · Cited by 10
“of 11 RCTs [185–195] were identified and included in the analysis.”
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An Inhibitory Antibody against Dipeptidyl Peptidase IV Improves Glucose Tolerance in Vivo
Tang, J., Majeti, J. Z., Sudom, A. M., Xiong, Y., Lu, M. P., Liu, Q., Higbee, J., Zhang, Y., Wang, Y., Wang, W., et al. (2012) · Journal of Biological Chemistry · doi:10.1074/jbc.m112.396317 · Cited by 11
Vildagliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of type 2 diabetes
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“The decision of which DPP-4 inhibitor to use can be difficult as there is little difference in efficacy among the agents [67,68].”
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Falsely Accused? Insufficient Evidence to Conclude that Sitagliptin is a Cause of Chronic Cough
Dicpinigaitis, P. V., Satia, I., & Ferguson, N. (2020) · Lung · doi:10.1007/s00408-020-00329-2 · Cited by 10
Safety and effectiveness of newer antidiabetic medications during Ramadan fasting and safety of Ramadan fasting after bariatric surgery
Ahmed, M., Badi, S., Elidrisi, A., Husain, N. E., Zainudin, S. B., Mahmood, A., Abubaker, N. E., Alghamdi, A., & Ahmed, M. H. (2022) · Journal of Diabetes & Metabolic Disorders · doi:10.1007/s40200-022-01145-6 · Cited by 11
Renal posttransplantation diabetes mellitus: An overview
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Clinical audit of patients using DPP4 inhibitors in longstanding type 2 diabetes
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Emerging role of insulin with incretin therapies for management of type 2 diabetes
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Effectiveness and Safety of Sitagliptin in Patients with Beta-thalassaemia Major and Diabetes Mellitus: A Case Series
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The In Vitro Cytotoxicity, Genotoxicity and Oxidative Damage Potential of the Oral Dipeptidyl Peptidase-4 Inhibitor, Linagliptin, on Cultured Human Mononuclear Blood Cells
Cadirci, K. (2019) · Acta Endocrinologica (Bucharest) · doi:10.4183/aeb.2019.9 · Cited by 9
“Collectively, the therapeutic importance of DPP-4 inhibitors in T2DM is rapidly evolving as their potential strengths and is thought that this significance will become better defined via further investigations (6-11).”
Solubility profiles of linagliptin in pure and mixed solvents: Interactions and thermodynamic parameters
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Switching from Premixed Insulin To Basal Insulin Analogue For Type 2 Diabetes and Role of Dipeptidyl Peptidase-4 Inhibitors
Peralta, F. G., Abreu, C., Navarro, G. M., López-Morandeira, P., Pérez-Gutierrez, E., Cordero-García, B., & Brito-Sanfiel, M. Á. (2017) · Experimental and Clinical Endocrinology & Diabetes · doi:10.1055/s-0043-113453 · Cited by 8
Addressing Cardiovascular Risk in Patients With Type 2 Diabetes: Focus on Primary Care
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Authors: Richter, B., Bandeira-Echtler, E., Bergerhoff, K., & Lerch, C.
Affiliations: Düsseldorf University Hospital (DE)
ORCID: Richter, Bernd
Lerch, Christian
Venue: Cochrane Database of Systematic Reviews
Publisher: Wiley
Published: 2008-04-23
Volume: 2010
Issue: 1
Pages: CD006739-CD006739
ISSN: 1361-6137 (ISSN-L)
1465-1858
DOI: 10.1002/14651858.cd006739.pub2
PMC: PMC8985075
OpenAlex: W1916480346
Cited by: 308
References: 121
Citations by year: 2026: 2 · 2025: 2 · 2024: 6 · 2023: 5 · 2022: 9 · 2021: 7 · 2020: 15 · 2019: 13 · 2018: 9 · 2017: 9 · 2016: 16 · 2015: 27 · 2014: 18 · 2013: 33 · 2012: 30
FWCI: 4.84
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Locations: Cochrane Database of Systematic Reviews (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Peptidase Inhibition and Analysis
Keywords: type 2 diabetes, sitagliptin, vildagliptin, glycemic control, HbA1c, beta-cell function, weight change, hypoglycemia, infection, drug safety, oral antidiabetic drugs, GLP-1 receptor agonists, treatment costs, health-related quality of life
MeSH terms: Sitagliptin Phosphate, Vildagliptin, Adamantane, Diabetes Mellitus, Type 2, Humans, Nitriles, Pyrazines, Pyrrolidines, Triazoles, Randomized Controlled Trials as Topic, Dipeptidyl-Peptidase IV Inhibitors

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Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus

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