Evidence map›Paper›PMID 25998481›Full record

Trial reportJournal of clinical pharmacology2015

Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira, a fixed-ratio combination therapy.

Christoph Kapitza, Bruce Bode, Steen Hvass Ingwersen, Lisbeth Vestergård Jacobsen, Pernille Poulsen

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00983021. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
3.4field-weighted citation impact, top 7% 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.

NCT00983021 phase1completed

A Trial to Test for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9068 and Compared With NN1250 and NN2211 in Healthy Subjects

Ran2009Enrolled24Registered outcomes3Posted comparisons0ConditionsDiabetes, HealthyArmsinsulin degludec, insulin degludec/liraglutide, liraglutide, Placebo
Open the trial in the graph
NCT01336023 phase3completed

A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

Ran2011Enrolled1,663Registered outcomes5Posted comparisons2ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin degludec/liraglutide, liraglutide
Open the trial in the graph
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Review
  3. Observational
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Insulin Degludec/Liraglutide.Hospital pharmacy · 2017
    Review
  10. Glycemic Control in a Real-Life Setting in Patients with Type 2 Diabetes Treated with IDegLira at a Single Swiss Center.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017
    Article
  11. Review
  12. Article
  13. Review
  14. Concentrated insulins: the new basal insulins.Therapeutics and clinical risk management · 2016
    Review
  15. 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

5 authors at 3 institutions in 3 countries.

Christoph KapitzaProfil, Neuss, Germany.
Bruce BodeAtlanta Diabetes Associates, Atlanta, GA, USA.
Steen Hvass IngwersenGlobal Development, Novo Nordisk A/S, Søborg, Denmark.
Lisbeth Vestergård JacobsenGlobal Development, Novo Nordisk A/S, Søborg, Denmark.
Pernille PoulsenGlobal Development, Novo Nordisk A/S, Søborg, Denmark.
Novo Nordisk (Denmark) · DKAtlanta Diabetes Associates · USProfil Institute for Metabolic Research · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Insulin degludec/liraglutide (IDegLira) is a novel fixed-ratio combination of the basal insulin insulin degludec (IDeg) and liraglutide, a glucagon-like peptide-1 analog. The pharmacokinetics (PK) and pharmacodynamics of IDegLira were assessed versus its components. A single-dose, randomized, 4-period crossover clinical pharmacology study in healthy subjects compared the bioavailability of IDegLira with its monocomponents. Dose proportionality, covariate effects on exposure, and exposure-response for change in glycated hemoglobin were analyzed based on data from a randomized treat-to-target phase 3 study in subjects with type 2 diabetes. Overall, the PK properties of IDeg and liraglutide were preserved for IDegLira. Liraglutide exposure was lower when dosed as IDegLira but met the criterion for equivalence. No relevant deviations from dose proportionality for the IDegLira components were observed. Covariate effects on exposure were consistent with previous results. Glycemic response to IDegLira was larger than with IDeg or liraglutide alone, reflecting their distinct glucose-lowering effects throughout the dose/exposure range.

Indexed as

AdolescentAdultBlood GlucoseDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug CombinationsFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulin, Long-ActingLiraglutideMaleMiddle AgedYoung AdultBlood GlucoseDrug CombinationsGlycated HemoglobinHypoglycemic AgentsIDegLirainsulin degludecInsulin, Long-ActingLiraglutideClinical Pharmacology (CPH)Drug InteractionsEndocrinology (END)Exposure-ResponsePharmacodynamics (PDY)Population Pharmacokinetics

Identifiers

PMID25998481
OpenAlexW2137037506

What OpenQuestion holds

Texttitle and abstract
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 OpenQuestion graph.