Evidence map›Paper›PMID 17596103›Full record

Trial reportClinical pharmacokinetics2007

Pharmacokinetics and pharmacodynamics of vildagliptin in patients with type 2 diabetes mellitus.

Yan-Ling He, Denise Serra, Yibin Wang, Joelle Campestrini, Gilles-Jacques Riviere, Carolyn F Deacon, Jens J Holst, Sherwyn Schwartz, Jace C Nielsen, Monica Ligueros-Saylan

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 3% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 105 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 5 countries.

Yan-Ling HeNovartis Institutes for BioMedical Research, Inc., Cambridge, Massachusetts 02139-3584, USA. yanling.he@novartis.com
Denise Serra
Yibin Wang
Joelle Campestrini
Gilles-Jacques Riviere
Carolyn F Deacon
Jens J Holst
Sherwyn Schwartz
Jace C Nielsen
Monica Ligueros-Saylan
Novartis (United States) · USNovartis (France) · FRUniversity of Copenhagen · DKCognizant (United States) · USDiabetes & Glandular Disease Clinic · USNovartis (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVildagliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor currently under development for the treatment of type 2 diabetes mellitus.

objectivesTo assess the pharmacokinetic and pharmacodynamic characteristics and tolerability of vildagliptin at doses of 10 mg, 25 mg and 100 mg twice daily following oral administration in patients with type 2 diabetes.

methodsThirteen patients with type 2 diabetes were enrolled in this randomised, double-blind, double-dummy, placebo-controlled, four-period, crossover study. Patients received vildagliptin 10 mg, 25 mg and 100 mg as well as placebo twice daily for 28 days.

resultsVildagliptin was absorbed rapidly (median time to reach maximum concentration 1 hour) and had a mean terminal elimination half-life ranging from 1.32 to 2.43 hours. The peak concentration and total exposure increased in an approximately dose-proportional manner. Vildagliptin inhibited DPP-4 (>90%) at all doses and demonstrated a dose-dependent effect on the duration of inhibition. The areas under the plasma concentration-time curves of glucagon-like peptide-1 (GLP-1) [p < 0.001] and glucose-dependent insulinotropic peptide (GIP) [p < 0.001] were increased whereas postprandial glucagon was significantly reduced at the 25 mg (p = 0.006) and 100mg (p = 0.005) doses compared with placebo. As compared with placebo treatment, mean plasma glucose concentrations were decreased by 1.4 mmol/L with the vildagliptin 25 mg dosing regimen and by 2.5 mmol/L with the 100 mg dosing regimen, corresponding to a 10% and 19% reduction, respectively. Vildagliptin was generally well tolerated.

conclusionVildagliptin is likely to be a useful therapy for patients with type 2 diabetes based on the inhibition of DPP-4 and the subsequent increase in incretin hormones, GLP-1 and GIP, and the decrease in glucose and glucagon levels.

Indexed as

AdamantaneAdministration, OralAdultAgedArea Under CurveBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleGastric Inhibitory PolypeptideGlucagon-Like Peptide 1Half-LifeHumansAdamantaneBlood GlucoseGastric Inhibitory PolypeptideGlucagon-Like Peptide 1Hypoglycemic AgentsNitrilesPyrrolidinesVildagliptin

Identifiers

PMID17596103
OpenAlexW2033198459

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.