Evidence map›Paper›PMID 22809630›Full record

Trial reportDiabetes & metabolism2012

Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study.

B Guerci, L Monnier, P Serusclat, C Petit, P Valensi, D Huet, D Raccah, C Colette, S Quéré, S Dejager

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes & metabolism, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02925559 (Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
4.8field-weighted citation impact, top 4% 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.

NCT02925559 phase4completedstarted 2016, after this paper: background citation

Effect of Anti-diabetic Drugs on Glycemic Variability. A Comparison Between Gliclazide MR (Modified Release) and Dapagliflozin on Glycemic Variability Measured by Continuous Glucose Monitoring (CGM) in Patients With Uncontrolled Type 2 Diabetes

Ran2016Enrolled135Registered outcomes9Posted comparisons0ConditionsDiabetes Mellitus, Type 2Armsdapagliflozin, Gliclazide MR
Open the trial in the graph
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 80 citations in OpenAlex.

  1. Trial
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  9. Article
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  11. Recommendations for Practical Use of Metformin, a Central Pharmacological Therapy in Type 2 Diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2022
    Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Cardiovascular Risk Factors: It's Time to Focus on Variability!Journal of lipid and atherosclerosis · 2020
    Review
  17. Article
  18. Review
  19. Glycemic Variability: Risk Factors, Assessment, and Control.Journal of diabetes science and technology · 2019
    Review
  20. Review
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 7 institutions in 1 country.

B GuerciUniversity of Nancy I and Diabetology, Nutrition and Metabolic disease, Brabois Hospital, and CIC Inserm ILCV, CHU of Nancy, Vandoeuvre-lès-Nancy, France.
L Monnier
P Serusclat
C Petit
P Valensi
D Huet
D Raccah
C Colette
S Quéré
S Dejager
Institut Universitaire de Recherche Clinique · FRNovartis (France) · FRCentre Hospitalier Sud Francilien · FRHôpital Jean-Verdier · FRHôpital Paris Saint-Joseph · FRHôpital Sainte-Marguerite · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo compare continuous glucose monitoring (CGM) profiles on vildagliptin versus sitagliptin in addition to metformin, in patients with inadequately controlled type 2 diabetes mellitus (HbA(1c) 6.5-8.0%).

methodsA multicenter, prospective, randomised, open-label study with blinded endpoint analysis. CGM data acquired over three days--firstly on metformin alone and then 8 weeks after the addition of either vildagliptin (n=14) or sitagliptin (n=16)--were blinded and analyzed centrally.

resultsIn comparable populations with a mean baseline HbA1c of 7.1%, 24-hour glucose variability--measured by mean amplitude of glucose excursions and standard deviation of mean glucose concentration--showed similar improvement on both drugs versus metformin alone. In contrast, a series of predefined parameters reflecting daily glycaemic control--mean 24-hour blood glucose concentration, and the times spent in the optimal glycaemic range (70-140 mg/dL) and above the hyperglycaemic thresholds of 140 and 180 mg/dL together with the corresponding AUC values--were significantly improved from baseline only in the vildagliptin arm. In addition, overall hyperglycaemia (AUC[24 h] > 100 mg/dL) significantly dropped from baseline on vildagliptin [-37%] but not on sitagliptin [-9%], while postprandial hyperglycaemia (AUC[0-4 h] × 3) was significantly reduced on both, and basal hyperglycaemia (overall--postprandial hyperglycaemia was reduced only on vildagliptin [-41%; P = 0.04]).

conclusionsThe addition of a DPP-4 inhibitor significantly reduced glycaemic variability with no difference between the two drugs. However, vildagliptin induced better circadian glycaemic control than sitagliptin with a significant decrease on overall hyperglycemia, mainly driven by reduction on basal hyperglycaemia.

Indexed as

AdamantaneAdolescentAdultAgedAged, 80 and overBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDrug Therapy, CombinationFemaleFranceHumansHyperglycemiaHypoglycemic AgentsMaleAdamantaneBlood GlucoseDipeptidyl-Peptidase IV InhibitorsHypoglycemic AgentsMetforminNitrilesPyrazinesPyrrolidinesSitagliptin PhosphateTriazolesVildagliptin

Identifiers

PMID22809630
OpenAlexW2017252684

What Socratic holds

Texttitle and abstract
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 Socratic graph.