ArticleDiabetology & metabolic syndrome2012
The efficacy and safety of the dipeptidyl peptidase-4 inhibitor saxagliptin in treatment-naïve patients with type 2 diabetes mellitus: a randomized controlled trial.
Article in Diabetology & metabolic syndrome, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00316082. Cited by 26 papers, 7 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Open the trial in the graphWho cites it
26 citing papers in PubMed, 7 syntheses or guidelines pooled it, 66 citations in OpenAlex.
- Dipeptidyl peptidase 4 (DPP-4) inhibitors for people with chronic kidney disease and diabetes.The Cochrane database of systematic reviews · 2025Pooled it
- Dipeptidyl peptidase-4 inhibitors and gallbladder or biliary disease in type 2 diabetes: systematic review and pairwise and network meta-analysis of randomised controlled trials.BMJ (Clinical research ed.) · 2022Pooled it
- Age, sex, disease severity, and disease duration difference in placebo response: implications from a meta-analysis of diabetes mellitus.BMC medicine · 2020Pooled it
- Insulin and glucose-lowering agents for treating people with diabetes and chronic kidney disease.The Cochrane database of systematic reviews · 2018Pooled it
- Efficacy and safety of saxagliptin in patients with type 2 diabetes: A systematic review and meta-analysis.PloS one · 2018Pooled it
- Factors Related to the Glucose-Lowering Efficacy of Dipeptidyl Peptidase-4 Inhibitors: A Systematic Review and Meta-Analysis Focusing on Ethnicity and Study Regions.Clinical drug investigation · 2017Pooled it
- The placebo response of injectable GLP-1 receptor agonists vs. oral DPP-4 inhibitors and SGLT-2 inhibitors: a systematic review and meta-analysis.British journal of clinical pharmacology · 2016Pooled it
- Efficacy and safety of dapagliflozin plus saxagliptin versus insulin glargine over 52 weeks as add-on to metformin with or without sulphonylurea in patients with type 2 diabetes: A randomized, parallel-design, open-label, Phase 3 trial.Diabetes, obesity & metabolism · 2020Trial
- Trial
- Tolerability and efficacy of glycemic control with saxagliptin in older patients (aged ≥ 65 years) with inadequately controlled type 2 diabetes mellitus.Clinical interventions in aging · 2013Trial
- Pharmacogenomic study of the effects of saxagliptin on glucose control and hypoglycemic events.BMC medical genomics · 2026Article
- Choice of Glucose-Lowering Drugs as Initial Monotherapy for Type 2 Diabetes Patients with Contraindications or Intolerance to Metformin: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2022Review
- Cost-Utility Analysis of Saxagliptin/Dapagliflozin Versus Gliclazide and Insulin Glargine: Economic Implications of the Outcomes of the CVD-Real Studies I and II.Health services insights · 2020Article
- Odds of Acute Kidney Injury in Patients Receiving Dipeptidyl Peptidase 4 Inhibitors: A National Cohort Study Within the Department of Veterans Affairs.Clinical and translational science · 2019Article
- Assessment of Saxagliptin Efficacy: Meta-Analysis of 14 Phase 2 and 3 Clinical Trials.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017Article
- Clinical Pharmacokinetics and Pharmacodynamics of Saxagliptin, a Dipeptidyl Peptidase-4 Inhibitor.Clinical pharmacokinetics · 2017Review
- Emerging use of combination therapies for the management of type 2 diabetes - focus on saxagliptin and dapagliflozin.Diabetes, metabolic syndrome and obesity : targets and therapy · 2017 · on this mapReview
- Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016Article
- Utility of Saxagliptin in the Treatment of Type 2 Diabetes: Review of Efficacy and Safety.Advances in therapy · 2015Review
- Saxagliptin: A Review in Type 2 Diabetes.Drugs · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelled
backgroundThe aim of this study was to assess efficacy and safety of saxagliptin monotherapy for up to 76 weeks in patients with type 2 diabetes mellitus (T2DM) and inadequate glycemic control, with main efficacy assessment at 24 weeks.
methods365 treatment-naïve patients with T2DM (HbA1c 7.0%-10.0%) were treated with saxagliptin 2.5 mg q.A.M., saxagliptin 2.5 mg q.A.M. with possible titration to saxagliptin 5 mg, saxagliptin 5 mg q.A.M., saxagliptin 5 mg q.P.M., or placebo. After week 24, patients in all groups were eligible for titration to saxagliptin 10 mg based on HbA1c ≥7%, and all unrescued placebo patients began blinded metformin 500 mg/day. Rescue with open-label metformin was available for patients with inadequate glycemic control.
resultsAt week 24, placebo-subtracted mean HbA1c reduction from baseline (LOCF) was significantly greater in the saxagliptin treatment groups vs placebo, and remained greater through week 76. Serious adverse events (AEs) and discontinuations due to AEs were similar in saxagliptin and control groups; incidence of confirmed hypoglycemia was low across all treatment groups (saxagliptin-treated, 2 [0.7]; control, 1 [1.4]).
conclusionsIn treatment-naïve patients with T2DM, saxagliptin monotherapy demonstrated statistically significant improvement in HbA1c compared with placebo at 24 weeks and was generally well tolerated for up to 76 weeks.
trial registrationClinicalTrials.gov Identifier: NCT00316082.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.