Evidence map›Paper›PMID 17387446›Full record

Trial reportDiabetologia2007

Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes.

V Fonseca, A Schweizer, D Albrecht, M A Baron, I Chang, S Dejager

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02104804 (A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Chinese Subjects in China With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination With Metformin), which is not on this map. Cited by 107 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 12 pooled it
27.9field-weighted citation impact, top 1% 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.

NCT02104804 phase3completednot on this mapstarted 2014, after this paper: background citation

A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Chinese Subjects in China With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination With Metformin

TypeinterventionalSponsorAstraZenecaRan2014 to 2016Enrolled953ConditionsType 2 Diabetes MellitusArmsSaxagliptin 5mg, Placebo for Saxagliptin
3 · Its place in the literature

Who cites it

107 citing papers in PubMed, 12 syntheses or guidelines pooled it, 369 citations in OpenAlex.

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  11. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2008
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47 more citing papers are in PubMed but not listed here.

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

6 authors at 3 institutions in 2 countries.

V FonsecaEndocrinology Department, Tulane University Health Sciences Center, 1430 Tulane Avenue, New Orleans, LA 70112, USA. vfonseca@tulane.edu
A Schweizer
D Albrecht
M A Baron
I Chang
S Dejager
Novartis (Switzerland) · CHNovartis (United States) · USTulane University · US

Funding

ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI BRENNER, DAVID A. · 1985 to 2010
$74.3M
ZENARESTAT IN DIABETIC NEUROPATHYM01RR005096 · NCRR · TULANE UNIVERSITY OF LOUISIANA · PI MILLER, ALAN M · 1990 to 2006
$17.4M
NCRR NIH HHS 5M01 RR 05096NCRR NIH HHS RR 00827
6 · The paper itself

Abstract

aims/hypothesisType 2 diabetes is difficult to manage in patients with a long history of disease requiring insulin therapy. Moreover, addition of most currently available oral antidiabetic agents increases the risk of hypoglycaemia. Vildagliptin is a dipeptidyl peptidase-IV inhibitor, which improves glycaemic control by increasing pancreatic beta cell responsiveness to glucose and suppressing inappropriate glucagon secretion. This study assessed the efficacy and tolerability of vildagliptin added to insulin therapy in patients with type 2 diabetes. MATERIALS AND

methodsThis was a multicentre, 24-week, double-blind, randomised, placebo-controlled, parallel-group study in patients with type 2 diabetes that was inadequately controlled (HbA(1c) = 7.5-11%) by insulin. Patients received vildagliptin (n = 144; 50 mg twice daily) or placebo (n = 152) while continuing insulin therapy.

resultsBaseline HbA(1c) averaged 8.4 +/- 0.1% in both groups. The adjusted mean change from baseline to endpoint (AMDelta) in HbA(1c) was -0.5 +/- 0.1% and -0.2 +/- 0.1% in patients receiving vildagliptin or placebo, respectively, with a significant between-treatment difference (p = 0.01). In patients aged >/=65 years, the AMDelta HbA(1c) was -0.7 +/- 0.1% in the vildagliptin group vs -0.1 +/- 0.1% in the placebo group (p < 0.001). The incidence of adverse events was similar in the vildagliptin (81.3%) and placebo (82.9%) groups. However, hypoglycaemic events were less common (p < 0.001) and less severe (p < 0.05) in patients receiving vildagliptin than in those receiving placebo. CONCLUSIONS/

interpretationVildagliptin decreases HbA(1c) in patients whose type 2 diabetes is poorly controlled with high doses of insulin. Addition of vildagliptin to insulin therapy is also associated with reduced confirmed and severe hypoglycaemia. ClinicalTrials.gov ID no.: NCT 00099931.

Indexed as

AdamantaneAgedBlood GlucoseBody Mass IndexDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinMaleMiddle AgedNitrilesAdamantaneBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinNitrilesPlacebosPyrrolidinesVildagliptin

Identifiers

PMID17387446
OpenAlexW1970406523

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.