ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2015
A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Co-Administration of Sitagliptin with Intensively Titrated Insulin Glargine.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01462266. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin
Open the trial in the graphWho cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Meta-Analysis of 11 Heterogeneous Studies regarding Dipeptidyl Peptidase 4 Inhibitor Add-On Therapy for Type 2 Diabetes Mellitus Patients Treated with Insulin.Journal of diabetes research · 2020Pooled it
- Pooled it
- A randomized, placebo-controlled study to evaluate the efficacy and safety of adding omarigliptin to insulin therapy in Japanese patients with type 2 diabetes and inadequate glycaemic control.Diabetes, obesity & metabolism · 2021Trial
- Double-blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase-4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT-I Study.Diabetes, obesity & metabolism · 2019Trial
- Reassessing the risk-modifying effects of novel antidiabetic agents on asthma-COPD overlap syndrome: a dose-stratified network meta-analysis of 316,832 adults from 128 randomised trials.EClinicalMedicine · 2026Article
- Impact of concomitant oral glucose-lowering medications on the success of basal insulin titration in insulin-naïve patients with type 2 diabetes: a systematic analysis.BMJ open diabetes research & care · 2023Review
- Efficient Multiple Imputation for Sensitivity Analysis of Recurrent Events Data with Informative Censoring.Statistics in biopharmaceutical research · 2022Article
- Impact of the Fasting Plasma Glucose Titration Target on the Success of Basal Insulin Titration in Insulin-Naïve Patients with Type 2 Diabetes: A Systematic Analysis.Journal of diabetes research · 2022Article
- Effect of Dipeptidyl Peptidase 4 Inhibitors Used in Combination with Insulin Treatment in Patients with Type 2 Diabetes: A Systematic Review and Meta-analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Article
- Dipeptidyl peptidase-4 inhibitors as add-on therapy to insulin in patients with type 2 diabetes mellitus: a meta-analysis of randomized controlled trials.Diabetes, metabolic syndrome and obesity : targets and therapy · 2019Article
- Safety and Efficacy of DPP4 Inhibitor and Basal Insulin in Type 2 Diabetes: An Updated Review and Challenging Clinical Scenarios.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Review
- Efficacy and Safety of Sitagliptin in Hispanic/Latino Patients with Type 2 Diabetes: A Pooled Analysis from Ten Randomized, Placebo-Controlled Phase 3 Clinical Trials.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Article
- Comparison of non-insulin antidiabetic agents as an add-on drug to insulin therapy in type 2 diabetes: a network meta-analysis.Scientific reports · 2018Article
- Sitagliptin: A Review in Type 2 Diabetes.Drugs · 2017Review
- Insulin monotherapy compared with the addition of oral glucose-lowering agents to insulin for people with type 2 diabetes already on insulin therapy and inadequate glycaemic control.The Cochrane database of systematic reviews · 2016Review
- Medium-Term Effect of Add-On Therapy with the DPP-4 Inhibitor, Sitagliptin, in Insulin-Treated Japanese Patients with Type 2 Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016Article
- Dipeptidyl peptidase-4 inhibitors or sodium glucose co-transporter-2 inhibitors as an add-on to insulin therapy: A comparative review.Indian journal of endocrinology and metabolismReview
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe objective of this study was to assess the effect of sitagliptin on insulin dose in patients with inadequately controlled type 2 diabetes who titrate basal insulin to a target fasting glucose level after initiating sitagliptin.
methodsThis was a multicenter, randomized, double-blind, placebo-controlled, 24-week clinical trial in which treatment with sitagliptin 100 mg/day or placebo was administered concurrently with insulin glargine titration, targeting a fasting glucose of 4.0-5.6 mmol/L (72-100 mg/dL). The trial randomized 660 patients with type 2 diabetes and inadequate glycemic control on insulin, with or without metformin (≥1500 mg/day) or sulfonylurea, for ≥10 weeks. Patients could remain on metformin but not sulfonylurea after randomization.
resultsThe increase from baseline in the daily dose of insulin was less in the sitagliptin group (N = 329) compared to placebo (N = 329) (between group difference = -4.7 IU [95% confidence interval [CI] -8.3, -1.2]; p = 0.009). Patients in the sitagliptin group had lower glycated hemoglobin (HbA1c) levels after 24 weeks (between-group difference of -0.4% [95% CI -0.6, -0.3; -4.9 mmol/mol (95% CI -6.6, -3.2)]; p < 0.001), and more patients in the sitagliptin group reached the HbA1c goal of <7.0% (53 mmol/mol), with a between-group difference of 17.3% (95% CI 10.4%, 24.1%; p < 0.001). Fewer patients in the sitagliptin group experienced an adverse event of hypoglycemia (between-group difference = -15.5%, p < 0.001).
conclusionAdministration of sitagliptin prior to intensive titration of basal insulin glargine reduces the insulin dose requirement while providing superior glycemic control and less hypoglycemia, compared to an insulin-only regimen.
fundingMerck & Co., Inc., Kenilworth, NJ, USA.
Identifiers
What Socratic holds
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 Socratic graph.