Evidence map›Paper›PMID 16681561›Full record

Trial reportDiabetic medicine : a journal of the British Diabetic Association2006

Insulin detemir under steady-state conditions: no accumulation and constant metabolic effect over time with twice daily administration in subjects with Type 1 diabetes.

S Bott, C Tusek, L V Jacobsen, L Endahl, E Draeger, C Kapitza, T Heise

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Diabetic medicine : a journal of the British Diabetic Association, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02587741 (Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT02587741 early_phase1unknown statusstarted 2015, after this paper: background citation

Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens: a Multicentre Randomized Parallel-group Clinical Trial

Ran2015Enrolled600Registered outcomes6Posted comparisons0ConditionsDiabetic RetinopathyArmsLantus, Metformin, Novomix30
Open the trial in the graph
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Insulin detemir for the treatment of obese patients with type 2 diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2012
    Article
  5. Article
  6. Detemir as a once-daily basal insulin in type 2 diabetes.Clinical pharmacology : advances and applications · 2011
    Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. 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

7 authors.

S BottProfil Institut für Stoffwechselforschung GmbH, Neuss, Germany.
C Tusek
L V Jacobsen
L Endahl
E Draeger
C Kapitza
T Heise

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis study investigated the pharmacodynamic and pharmacokinetic characteristics of the novel long-acting insulin analogue insulin detemir (IDet) under single-dose and steady-state conditions in comparison with those of NPH insulin at steady state.

methodsTwenty-five subjects with Type 1 diabetes [seven females, 18 males, mean age (+/- sd) 39 +/- 12 years, body mass index 24 +/- 3 kg/m(2)] participated in three 24-h glucose clamps. IDet or NPH were given at 12-h intervals in fixed, individualized doses. The first clamp assessed the metabolic effect of NPH at steady state, the second investigated the effect of two single injections of IDet. Subjects continued IDet treatment for 7-14 days, after which the third clamp was performed to investigate IDet at steady state.

resultsAt steady state, the metabolic effect of IDet was constant over 24 h while a clear peak in the metabolic effect [expressed as glucose infusion rates (GIR)] was observed with NPH after each injection. The fluctuation in the metabolic effect (maximum GIR divided by the average of the GIR values at the interval ends) was significantly lower in the second 12 h of the experiments with IDet under steady-state conditions compared with NPH (fluctuation(12-24 h) 1.27 +/- 0.17 vs. 1.56 +/- 0.72, P < 0.05). The overall metabolic effect of IDet at steady state was comparable with that of NPH [GIR-area under curve (AUC)(0-24 h): 5697 +/- 1861 vs. 5929 +/- 1965 mg/kg] whereas a significantly lower effect (5187 +/- 1784 mg/kg, P = 0.01 vs. steady state) was observed following the first two IDet injections. GIR values at the end of clamp day 2 (first doses) and clamp day 3 (steady state) were comparable [GIR(trough 24 h) 3.7 +/- 1.7 vs. 3.8 +/- 1.6 mg/(kg x min) NS], indicating that IDet had reached steady state after the first two injections.

conclusionsIDet administered twice daily reached steady state after the second injection and showed a constant metabolic effect over time under steady-state conditions. This should facilitate basal insulin substitution and decrease the risk of hypoglycaemia in insulin-treated subjects.

Indexed as

AdultDiabetes Mellitus, Type 1Drug Administration ScheduleFemaleGlucoseGlucose Clamp TechniqueHumansHypoglycemic AgentsInfusions, ParenteralInjectionsInsulinInsulin DetemirInsulin, IsophaneInsulin, Long-ActingMaleGlucoseHypoglycemic AgentsInsulinInsulin DetemirInsulin, IsophaneInsulin, Long-Acting

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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.