Evidence map›Paper›PMID 24920915›Full record

Trial reportVascular health and risk management2014

A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study.

Mohamed Hassanein, Khalifa Abdallah, Anja Schweizer

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vascular health and risk management, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01758380. Cited by 39 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 6 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT01758380 phase4completed

A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

Ran2013Enrolled557Registered outcomes11Posted comparisons0ConditionsType 2 Diabetes MellitusArmsGliclazide, Metformin, Placebo to Gliclazide, Placebo to Vildagliptin, vildagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 6 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Current Position of Gliclazide and Sulfonylureas in the Contemporary Treatment Paradigm for Type 2 Diabetes: A Scoping Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
    Article
  9. Observational
  10. Review
  11. Review
  12. Comparison of gliclazideWorld journal of diabetes · 2022
    Article
  13. Review
  14. Article
  15. Management of Diabetes and Hypertension within the Gulf Region: Updates on Treatment Practices and Therapies.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022
    Review
  16. Article
  17. Article
  18. Ramadan and Diabetes: A Narrative Review and Practice Update.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  19. Ramadan and Diabetes: A Narrative Review and Practice Update.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  20. Role of Gliclazide MR in the Management of Type 2 Diabetes: Report of a Symposium on Real-World Evidence and New Perspectives.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    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

3 authors at 3 institutions in 3 countries.

Mohamed HassaneinBetsi Cadwaladr University Health Board, Wales, United Kingdom.
Khalifa AbdallahClinical Research Center, Alexandria University Hospital, Alexandria, Egypt.
Anja SchweizerGlobal Medical Affairs, Novartis Pharma AG, Basel, Switzerland.
Alexandria University · EGBetsi Cadwaladr University Health Board · GBNovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSeveral observational studies were conducted with vildagliptin in patients with type 2 diabetes mellitus (T2DM) fasting during Ramadan, showing significantly lower incidences of hypoglycemia with vildagliptin versus sulfonylureas, including gliclazide. It was of interest to complement the existing real-life evidence with data from a randomized, double-blind, clinical trial. CLINICAL TRIALS IDENTIFIER: NCT01758380.

methodsThis multiregional, double-blind study randomized 557 patients with T2DM (mean glycated hemoglobin [HbA1c], 6.9%), previously treated with metformin and any sulfonylurea to receive either vildagliptin (50 mg twice daily) or gliclazide plus metformin. The study included four office visits (three pre-Ramadan) and multiple telephone contacts, as well as Ramadan-focused advice. Hypoglycemic events were assessed during Ramadan; HbA(1c) and weight were analyzed before and after Ramadan.

resultsThe proportion of patients reporting confirmed (<3.9 mmol/L and/or severe) hypoglycemic events during Ramadan was 3.0% with vildagliptin and 7.0% with gliclazide (P=0.039; one-sided test), and this was 6.0% and 8.7%, respectively, for any hypoglycemic events (P=0.173). The adjusted mean change pre- to post-Ramadan in HbA(1c) was 0.05%±0.04% with vildagliptin and -0.03%±0.04% with gliclazide, from baselines of 6.84% and 6.79%, respectively (P=0.165). In both groups, the adjusted mean decrease in weight was -1.1±0.2 kg (P=0.987). Overall safety was similar between the treatments.

conclusionIn line with the results from previous observational studies, vildagliptin was shown in this interventional study to be an effective, safe, and well-tolerated treatment in patients with T2DM fasting during Ramadan, with a consistently low incidence of hypoglycemia across studies, accompanied by good glycemic and weight control. In contrast, gliclazide showed a lower incidence of hypoglycemia in the present interventional than the previous observational studies. This is suggested to be linked to the specific circumstances of this study, including frequent patient-physician contacts, Ramadan-focused advice, a recent switch in treatment, and very well-controlled patients, which is different from what is often seen in real life.

Indexed as

FastingIslamOffice VisitsReligion and MedicineTelephoneAdamantaneAsiaBiomarkersBlood GlucoseBody WeightCounselingDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodEuropeFemaleAdamantaneBiomarkersBlood GlucoseDipeptidyl-Peptidase IV InhibitorsGliclazideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsNitrilesPyrrolidinesVildagliptindipeptidyl peptidase 4fastinghypoglycemiaincretinRamadantype 2 diabetes mellitus

Identifiers

PMID24920915
PMCPMC4045264
OpenAlexW2131415410

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.