Evidence map›Paper›PMID 23393185›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2013

Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension.

Chantal Mathieu, Priscilla Hollander, Bresta Miranda-Palma, John Cooper, Edward Franek, David Russell-Jones, Jens Larsen, Søren Can Tamer, Stephen C Bain, NN1250-3770 (BEGIN: Flex T1) Trial Investigators

Abstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 89 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
89citing papers in PubMed, 7 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.

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

89 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  12. Insulin depot absorption modeling and pharmacokinetic simulation with insulin glargine 300 U/mL
.International journal of clinical pharmacology and therapeutics · 2019
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29 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

10 authors.

Chantal MathieuClinical and Experimental Endocrinology, UZ Herestraat 49, Box 902, Room 08.43, 3000 Leuven, Belgium. chantal.mathieu@uzleuven.be
Priscilla Hollander
Bresta Miranda-Palma
John Cooper
Edward Franek
David Russell-Jones
Jens Larsen
Søren Can Tamer
Stephen C Bain
NN1250-3770 (BEGIN: Flex T1) Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study investigated the efficacy and safety of insulin degludec (IDeg) once daily (OD), varying injection timing day to day in subjects with type 1 diabetes. RESEARCH DESIGN AND

methodsThis 26-week, open-label, treat-to-target, noninferiority trial compared IDeg forced flexible (Forced-Flex) OD (given in a fixed schedule with a minimum 8 and maximum 40 hours between doses) with IDeg or insulin glargine (IGlar) given at the same time daily OD. In the 26-week extension, all IDeg subjects were transferred to a free-flexible (Free-Flex) regimen, which allowed any-time-of-day dosing, and compared with subjects continued on IGlar.

resultsAfter 26 treatment weeks, mean glycosylated hemoglobin was reduced with IDeg Forced- Flex (-0.40%), IDeg (-0.41%), and IGlar (-0.58%). IDeg Forced-Flex noninferiority was achieved. Fasting plasma glucose reductions were similar with IDeg Forced-Flex and IGlar but greater with IDeg (-2.54 mmol/L) than IDeg Forced-Flex (-1.28 mmol/L) (P = .021). At week 52, IDeg Free-Flex subjects had similar glycosylated hemoglobin but greater fasting plasma glucose reductions than IGlar subjects (-1.07 mmol/L) (P = .005). Confirmed hypoglycemia rates (plasma glucose <3.1 mmol/L or severe hypoglycemia) were similar at weeks 26 and 52. Nocturnal confirmed hypoglycemia was lower with IDeg Forced-Flex vs IDeg (37%; P = .003) and IGlar (40%; P = .001) at week 26 and 25% lower with IDeg Free-Flex vs IGlar (P = .026) at week 52.

conclusionsIDeg can be administered OD at any time of day, with injection timing varied without compromising glycemic control or safety vs same-time-daily IDeg or IGlar. This may improve basal insulin adherence by allowing injection-time adjustment according to individual needs.

Indexed as

AdultBlood GlucoseDiabetes Mellitus, Type 1Dose-Response Relationship, DrugDrug Administration ScheduleFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingMaleMiddle AgedSelf AdministrationTreatment OutcomeBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic Agentsinsulin degludecInsulin GlargineInsulin, Long-Acting

Identifiers

PMID23393185
PMCPMC3612802

What Socratic holds

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LicenceCC BY-NC
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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 Socratic graph.