Evidence map›Paper›PMID 21951832›Full record

Trial reportInternational journal of clinical practice2011

The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial.

S Al Sifri, A Basiounny, A Echtay, M Al Omari, I Harman-Boehm, G Kaddaha, K Al Tayeb, A S Mahfouz, A Al Elq, L Radican and 8 more

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

Trial report in International journal of clinical practice, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01131182. Cited by 47 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT01131182 phase4completed

An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting

Ran2010Enrolled1,147Registered outcomes2Posted comparisons1ConditionsType 2 Diabetes Mellitus (T2DM)ArmsComparator: Sulfonylurea, Metformin, sitagliptin phosphate
Open the trial in the graph
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. 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
  10. Observational
  11. Review
  12. Review
  13. Article
  14. 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
  15. Article
  16. Article
  17. Ramadan and Diabetes: A Narrative Review and Practice Update.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  18. Ramadan and Diabetes: A Narrative Review and Practice Update.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  19. 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
  20. Article
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

18 authors.

S Al SifriAl Hada Military Hospital, Taif, Saudi Arabia.
A Basiounny
A Echtay
M Al Omari
I Harman-Boehm
G Kaddaha
K Al Tayeb
A S Mahfouz
A Al Elq
L Radican
C Ozesen
H L Katzeff
B J Musser
S Suryawanshi
C J Girman
M J Davies
S S Engel
2010 Ramadan Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo compare the incidence of symptomatic hypoglycaemia in fasting Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan.

methodsPatients with type 2 diabetes (age ≥ 18 years) who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months prior to screening, who had an HbA(1c) < 10% and who expressed their intention to daytime fast during Ramadan were eligible for this open-label study. Patients were randomised in a 1 : 1 ratio to either switch to sitagliptin 100 mg qd or to remain on their prestudy sulphonylurea. Patients completed daily diary cards to document information on hypoglycaemic symptoms and complications. The primary end-point was the overall incidence of symptomatic hypoglycaemia recorded during Ramadan.

resultsOf the 1066 patients randomised, 1021 (n = 507 for sitagliptin and n = 514 for sulphonylurea) returned at least one completed diary card and were included in the analysis. The proportion of patients who recorded one or more symptomatic hypoglycaemic events during Ramadan was lower in the sitagliptin group (6.7%) compared with the sulphonylurea group (13.2%). The risk of symptomatic hypoglycaemia was significantly decreased with sitagliptin relative to sulphonylurea treatment (Mantel-Haenszel relative risk ratio [95% CI] = 0.51 [0.34, 0.75]; p < 0.001). There were no reported events that required medical assistance (i.e. visits to physician or emergency room or hospitalisations) or were considered severe (i.e. events that caused loss of consciousness, seizure, coma or physical injury) during Ramadan.

conclusionsIn Muslim patients with type 2 diabetes who observed the fast during Ramadan, switching to a sitagliptin-based regimen decreased the risk of hypoglycaemia compared with remaining on a sulphonylurea-based regimen. The incidence of hypoglycaemia was lower with gliclazide relative to the other sulphonylurea agents and similar to that observed with sitagliptin.

Indexed as

IslamAdultAgedDiabetes Mellitus, Type 2Drug SubstitutionFastingFemaleHumansHypoglycemiaHypoglycemic AgentsIncidenceMaleMiddle AgedMiddle EastPyrazinesResidence CharacteristicsHypoglycemic AgentsPyrazinesSitagliptin PhosphateSulfonylurea CompoundsTriazoles

Identifiers

PMID21951832
PMCPMC3253336

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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.