Trial reportHormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme2008
Efficacy and safety of vildagliptin monotherapy during 2-year treatment of drug-naïve patients with type 2 diabetes: comparison with metformin.
Trial report in Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 7 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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 16-wk, Uni-center, Randomized, Double-blind, Parallel, Phase 3b Trial to Evaluate Efficacy of Saxagliptin + Dapagliflozin vs.Dapagliflozin With Regard to EGP in T2DM With Insufficient Glycemic Control on Metformin+/-Sulfonylurea Therapy
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Who cites it
34 citing papers in PubMed, 7 syntheses or guidelines pooled it, 92 citations in OpenAlex.
- Metformin monotherapy for adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2020 · on this mapPooled it
- Systematic review and meta-analysis of vildagliptin for treatment of type 2 diabetes.Endocrine · 2016 · on this mapPooled it
- Pooled it
- Pooled it
- Metformin therapy and risk of cancer in patients with type 2 diabetes: systematic review.PloS one · 2013 · on this mapPooled it
- [Recommendations for the pharmacological treatment of hyperglycemia in type 2 diabetes].Atencion primaria · 2011Guideline
- Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2010 · on this mapPooled it
- 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 · 2018Trial
- Study to determine the durability of glycaemic control with early treatment with a vildagliptin-metformin combination regimen vs. standard-of-care metformin monotherapy-the VERIFY trial: a randomized double-blind trial.Diabetic medicine : a journal of the British Diabetic Association · 2014Trial
- Efficacy and safety of vildagliptin in patients with type 2 diabetes mellitus inadequately controlled with dual combination of metformin and sulphonylurea.Diabetes, obesity & metabolism · 2014 · on this mapTrial
- Efficacy of vildagliptin in combination with insulin in patients with type 2 diabetes and severe renal impairment.Vascular health and risk management · 2013Trial
- DPP-4 inhibitors for treating T2DM - hype or hope? an analysis based on the current literature.Frontiers in molecular biosciences · 2023Review
- Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022Article
- Microvascular Outcomes in Patients with Type 2 Diabetes Treated with Vildagliptin vs. Sulfonylurea: A Retrospective Study Using German Electronic Medical Records.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016Article
- Efficacy and tolerability of vildagliptin as first line treatment in patients with diabetes type 2 in an outpatient setting.Journal of diabetes and metabolic disorders · 2015Article
- Use of Vildagliptin in Management of Type 2 Diabetes: Effectiveness, Treatment Persistence and Safety from the 2-Year Real-Life VILDA Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2014Article
- Review
- The efficacy of vildagliptin in korean patients with type 2 diabetes.Diabetes & metabolism journal · 2013Article
- Profile of vildagliptin in type 2 diabetes: efficacy, safety, and patient acceptability.Therapeutics and clinical risk management · 2013Article
- Evidence to support the use of vildagliptin monotherapy in the treatment of type 2 diabetes mellitus.Vascular health and risk management · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The present study was a 52-week extension of a previously published, multi-center, randomized, parallel-group study. The aim of this extension study was to compare the efficacy and tolerability of vildagliptin and metformin in drug-naïve patients with type 2 diabetes over 104 weeks. The extension population comprised 305 patients randomized to vildagliptin (100 mg daily) and 158 patients randomized to metformin (2 000 mg daily). Pioglitazone was added as rescue medication if fasting glucose was >10 mmol/l; data from patients receiving rescue medication were excluded from the primary analysis. Baseline HbA (1c) averaged 8.4+/-0.1% in patients randomized to vildagliptin and 8.8+/-0.1% in those randomized to metformin. The adjusted mean change from baseline to study endpoint was -1.0+/-0.1% in vildagliptin-treated patients and -1.5+/-0.1% in those receiving metformin (p<0.001 vs. vildagliptin). These results were similar to those reported after the 1-year core phase of the study. The adjusted mean changes in body weight from baseline to endpoint were 0.5+/-0.4 kg and -2.5+/-0.5 kg in the vildagliptin and metformin groups, respectively. One or more adverse event (AE) was reported by 82.2% of patients receiving vildagliptin and by 87.3% of those receiving metformin (p<0.001). Gastrointestinal AEs were more common in patients receiving metformin (45.6%) than in those receiving vildagliptin (25.0%, p<0.001 vs. metformin). One hypoglycemic event occurred after strenuous exercise in a single patient receiving vildagliptin (0.3%). In conclusion, both vildagliptin and metformin monotherapy provided clinically meaningful decreases in HbA (1c) over 2 years in drug-naïve patients with type 2 diabetes. Vildagliptin was weight neutral, while weight loss was observed with metformin; however, metformin was associated with significantly worse gastrointestinal tolerability.
Indexed as
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.