Evidence map›Paper›PMID 34531203›Full record

Trial reportBMJ open2021

Safety, feasibility and efficacy of metformin and sitagliptin in patients with a TIA or minor ischaemic stroke and impaired glucose tolerance.

Elizabeth Osei, Adrienne Zandbergen, Paul J A M Brouwers, Laus J M M Mulder, Peter Koudstaal, Hester Lingsma, Diederik W J Dippel, Heleen den Hertog

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 35% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Potential Therapeutic Properties of the Leaf ofPlants (Basel, Switzerland) · 2022
    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

8 authors at 5 institutions in 1 country.

Elizabeth OseiNeurology, Flevoziekenhuis, Almere, The Netherlands l.osei.neurologie@gmail.com.ORCID 0000-0001-9405-0583
Adrienne ZandbergenInternal Medicine, Erasmus MC, Rotterdam, The Netherlands.
Paul J A M BrouwersNeurology, Medisch Spectrum Twente, Enschede, The Netherlands.
Laus J M M MulderNeurology, Ikazia Hospital, Rotterdam, The Netherlands.
Peter KoudstaalNeurology, Erasmus MC, Rotterdam, The Netherlands.
Hester LingsmaPublic Health, Erasmus MC, Rotterdam, The Netherlands.
Diederik W J DippelNeurology, Erasmus MC, Rotterdam, The Netherlands.ORCID 0000-0002-9234-3515
Heleen den HertogNeurology, Isala Hospitals, Zwolle, The Netherlands.
Erasmus MC · NLFlevoziekenhuis · NLIkazia Ziekenhuis · NLIsala · NLMedisch Spectrum Twente · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionImpaired glucose tolerance (IGT) is highly prevalent after stroke and is associated with recurrent stroke and unfavourable outcome.

objectivesWe aimed to assess the feasibility, safety and effects on glucose metabolism of metformin or sitagliptin in patients with transient ischaemic attack (TIA) or minor ischaemic stroke and IGT.

designWe performed a multicentre, randomised, controlled, open-label phase II trial with blinded outcome assessment.

interventionsPatients were randomised in a 2:1:1 ratio to 'no medication', sitagliptin or metformin. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome measures were baseline adjusted differences of 2-hour postload glucose; secondary outcome measures fasting glucose, glycosylated haemoglobin 1c (HbA1c) levels, tolerability and safety of metformin and sitagliptin at 6 months. Patients on metformin or sitagliptin were contacted by telephone for recording of possible adverse events and to support continuation of treatment at 2 weeks, 6 weeks and 3 months after inclusion. These events were not analysed as outcome measures.

resultsFifty-three patients were randomised to control group, 26 to metformin and 22 to sitagliptin. We found no significant differences in 2-hour postload glucose between patients on antidiabetic drugs and controls ((-0.04 mmol/L (95% CI -0.53 to 0.45)). Patients in the treatment arms had reduced fasting glucose: ((-0.21 mmol/L (95% CI -0.36 to -0.06)) and HbA1c levels ((-1.16 mmol/mol (95% CI -1.84 to -0.49)). Thirteen patients (50%) on metformin and 7 (32%) on sitagliptin experienced side effects. Sixteen patients (61%) in the metformin and 13 (59%) in the sitagliptin group were still on treatment after 6 months.

conclusionsMetformin and sitagliptin were both effective in reducing fasting glucose and HbA1c levels in patients with recent TIA or minor ischaemic stroke and IGT. However, the reduction of glucose levels and sample size was relatively small. The clinical relevance, therefore, needs to be tempered. A phase III trial is needed to investigate whether medical treatment, compared with lifestyle intervention or a combination of both, not only improves glucose metabolism in IGT, but also leads to reduction of recurrent TIA or ischaemic stroke in these patients. TRIAL REGISTRATION NUMBER: NL3048.

Indexed as

Brain IschemiaDiabetes Mellitus, Type 2Glucose IntoleranceIschemic Attack, TransientIschemic StrokeMetforminStrokeBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationFeasibility StudiesGlycated HemoglobinHumansHypoglycemic AgentsSitagliptin PhosphateTreatment OutcomeBlood GlucoseGlycated HemoglobinHypoglycemic AgentsMetforminSitagliptin Phosphateadult neurologydiabetes & endocrinologygeneral diabetesneurologystroke

Identifiers

PMID34531203
PMCPMC8449977
OpenAlexW3200642155

What OpenQuestion holds

Texttitle and abstract
LicenceCC BY-NC
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.