Evidence map›Paper›PMID 24170235›Full record

SynthesisDrugs & aging2013

Elderly patients with diabetes experience a lower rate of nocturnal hypoglycaemia with insulin degludec than with insulin glargine: a meta-analysis of phase IIIa trials.

Christopher Sorli, Mark Warren, David Oyer, Henriette Mersebach, Thue Johansen, Stephen C L Gough

7 registry-linked trialsAbstract readMeta-Analysis
In one paragraph

Synthesis in Drugs & aging, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–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.

NCT00972283 phase3completednot on this map

NN1250-3582: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin ± Treatment With Metformin, ± Pioglitazone in Subjects With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment/NN1250-3667: An Extension Trial to NN1250-3582 Comparing Safety and Efficacy of NN1250 and Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin ± OADs in Type 2 Diabetes (BEGIN™: BB)

TypeinterventionalSponsorNovo Nordisk A/SRan2009 to 2010Enrolled1,006ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin glargine, insulin aspart
NCT00982228 phase3completednot on this map

NN1250-3583: A 52 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Parallel, Treat-to-target Trial Comparing Efficacy and Safety of SIBA and Insulin Glargine Both Administered Once Daily in a Basal-bolus Regimen With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes (BEGIN™: BB T1 LONG) / NN1250-3644: An Extension Trial to Trial NN1250-3583 Comparing Safety and Efficacy of NN1250 With Insulin Glargine, Both With Insulin Aspart as Meal-time Insulin, in Type 1 Diabetes (BEGIN™: T1)

TypeinterventionalSponsorNovo Nordisk A/SRan2009 to 2010Enrolled629ConditionsDiabetes, Diabetes Mellitus, Type 1Armsinsulin degludec, insulin glargine, insulin aspart
NCT00982644 phase3completednot on this map

NN1250-3579: A 52-week Randomised, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA and Insulin Glargine, Both Injected Once Daily in Combination With Oral Anti-diabetic Drugs (OAD), in Subjects With Type 2 Diabetes Mellitus Currently Treated With OAD(s) and Qualifying for More Intensified Treatment / NN1250-3643: An Extension Trial to NN1250-3579 Comparing Safety and Efficacy of NN1250 Plus OAD(s) With Insulin Glargine Plus OAD(s) in Type 2 Diabetes (BEGIN™: Once Long)

TypeinterventionalSponsorNovo Nordisk A/SRan2009 to 2010Enrolled1,030ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin glargine
NCT01006291 phase3completednot on this map

A 26 Week Randomised, Controlled, Open Label, Multicentre, Multinational, Three-arm, Treat to Target Trial Comparing Efficacy and Safety of Three Different Dosing Regimens of Either Soluble Insulin Basal Analogue (SIBA) or Insulin Glargine With or Without Combination With OAD Treatment, in Subjects With Type 2 Diabetes Mellitus (BEGIN™ : FLEX)

TypeinterventionalSponsorNovo Nordisk A/SRan2009 to 2010Enrolled687ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin glargine
NCT01059799 phase3completednot on this map

A Pan Asian Trial Comparing Efficacy and Safety of Insulin NN1250 and Insulin Glargine as Add on to OAD(s) in Subjects With Type 2 Diabetes (BEGIN™: ONCE ASIA)

TypeinterventionalSponsorNovo Nordisk A/SRan2010 to 2010Enrolled435ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin glargine
NCT01068665 phase3completednot on this map

A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)

TypeinterventionalSponsorNovo Nordisk A/SRan2010 to 2010Enrolled460ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin glargine
NCT01079234 phase3completednot on this map

A 26-week Trial Investigating the Dosing Flexibility, Efficacy and Safety of NN1250 in Subjects With Type 1 Diabetes With a 26-week Extension (Begin™: Flex T1)

TypeinterventionalSponsorNovo Nordisk A/SRan2010 to 2011Enrolled493ConditionsDiabetes, Diabetes Mellitus, Type 1Armsinsulin degludec, insulin glargine, insulin aspart
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. In-Hospital Management of Hyperglycemia: The Role of Insulin Degludec.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Review
  5. Article
  6. Review
  7. Review
  8. Understanding the Clinical Profile of Insulin Degludec, the Latest Basal Insulin Approved for Use in Canada: a Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
  9. Challenges of Diabetes Care in Older People With Type 2 Diabetes and the Role of Basal Insulin.Clinical diabetes : a publication of the American Diabetes Association · 2019
    Article
  10. Review
  11. Pursuit of a perfect insulin.Nature reviews. Drug discovery · 2016
    Review
  12. Concentrated insulins: the new basal insulins.Therapeutics and clinical risk management · 2016
    Review
  13. Review
  14. Review
  15. Degludec: the new ultra-long insulin analogue.Diabetology & metabolic syndrome · 2015
    Article
  16. Review
  17. Review
  18. 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

6 authors.

Christopher SorliDepartment of Diabetes, Endocrinology and Metabolism, Billings Clinic Research Center, 1045 North 30th, Billings, MT, 59101, USA, csorli@billingsclinic.org.
Mark Warren
David Oyer
Henriette Mersebach
Thue Johansen
Stephen C L Gough

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveElderly patients with diabetes are more vulnerable to the occurrence and effects of hypoglycaemia; therefore, treatments with low risk of hypoglycaemia are preferred in this population. This study aimed to compare hypoglycaemia rates between insulin degludec (IDeg) and insulin glargine (IGlar) in elderly patients.

methodsHypoglycaemia data from patients ≥65 years of age with type 1 (T1DM) or type 2 (T2DM) diabetes from seven randomised, treat-to-target phase IIIa trials were used to compare IDeg and IGlar in a pre-planned meta-analysis. Overall, 917/4345 (21 %) randomised patients in the seven trials were elderly (634 IDeg, 283 IGlar). Overall confirmed hypoglycaemia was defined as <3.1 mmol/L or severe hypoglycaemia (symptoms requiring external assistance). Nocturnal hypoglycaemia included confirmed episodes from 0001 to 0559 hours (inclusive). Treatment comparisons of hypoglycaemia in T1DM patients were not performed due to low numbers of elderly patients with T1DM randomised (43 IDeg, 18 IGlar); statistical comparisons were also not made for severe hypoglycaemia due to the low number of events.

resultsIn elderly patients with T2DM, the rate of overall confirmed hypoglycaemia was significantly lower with IDeg than IGlar [estimated rate ratio (ERR) 0.76 (0.61; 0.95)95 % CI]; nocturnal confirmed hypoglycaemia was also significantly lower with IDeg [ERR 0.64 (0.43; 0.95)95 % CI]. Confirmed hypoglycaemia occurred in the majority of T1DM patients, whereas severe episodes occurred infrequently and at similar rates in both treatment groups in T1DM and T2DM.

conclusionResults of this pre-planned meta-analysis in elderly patients with diabetes demonstrate a significant reduction in hypoglycaemic events with IDeg relative to IGlar.

Indexed as

AgedAged, 80 and overClinical Trials, Phase III as TopicDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2HumansHypoglycemiaHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingRandomized Controlled Trials as TopicHypoglycemic Agentsinsulin degludecInsulin GlargineInsulin, Long-Acting

Identifiers

PMID24170235
PMCPMC3832772

What OpenQuestion holds

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Registered trials

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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.