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Study · Randomized controlled trial · 2002

14 results

Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male subjects.

Elbrønd B, Jakobsen G, Larsen S, Agersø H, Jensen LB, Rolan P, Sturis J, Hatorp V, Zdravkovic M

Diabetes care1 Aug 2002Cited by 210 (Europe PMC)

PMID12145241 (opens in a new tab)DOI10.2337/diacare.25.8.1398 (opens in a new tab)PepBankPUB-12145241
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy men, the half-life of subcutaneous NN2211 (liraglutide) was 11-15 h.

    In plain wordsIn healthy men, the half-life of liraglutide (NN2211) after an injection under the skin was 11-15 hours.

    Peptide
    Liraglutide
    Outcome
    Not applicableElimination half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Measurements

    half-life
    11 to 15 h
    NN2211 s.c.

    Source sentences

    Summary
    After subcutaneous administration, the half-life of NN2211 was found to be 11-15 h.
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In healthy men, NN2211 gave a borderline-significant lowering of glucose levels (P = 0.066) versus placebo.

    In plain wordsIn healthy men, liraglutide (NN2211) lowered blood glucose only borderline compared with placebo, not clearly significant.

    Peptide
    Liraglutide
    Outcome
    No significant changeGlucose AUC (0-9 h)
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Measurements

    P value
    0.066
    glucose lowering

    Source sentences

    Summary
    Overall, although there were no statistically significant differences compared with placebo in the area under the curve (0-9 h for insulin or glucagon), there was a borderline- significant lowering of glucose levels (P = 0.066).
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In healthy men, NN2211 caused no statistically significant difference from placebo in insulin AUC (0-9 h).

    In plain wordsIn healthy men, liraglutide (NN2211) did not change insulin over 9 hours significantly compared with placebo.

    Peptide
    Liraglutide
    Outcome
    No significant changeInsulin AUC (0-9 h)
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Overall, although there were no statistically significant differences compared with placebo in the area under the curve (0-9 h for insulin or glucagon)
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In healthy men, NN2211 caused no statistically significant difference from placebo in glucagon AUC (0-9 h).

    In plain wordsIn healthy men, liraglutide (NN2211) did not change glucagon over 9 hours significantly compared with placebo.

    Peptide
    Liraglutide
    Outcome
    No significant changeGlucagon AUC (0-9 h)
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Glycemic control · Endocrine and hormones
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Overall, although there were no statistically significant differences compared with placebo in the area under the curve (0-9 h for insulin or glucagon)
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In healthy men, NN2211 significantly increased insulin secretion during an intravenous glucose tolerance test.

    In plain wordsIn healthy men, liraglutide (NN2211) significantly increased insulin release during a glucose tolerance test.

    Peptide
    Liraglutide
    Outcome
    IncreaseInsulin secretion during IVGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Measurements

    P value
    0.0002
    insulin secretion

    Source sentences

    Summary
    During the IVGTT, there was a statistically significant increase in insulin secretion (P = 0.0002)
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In healthy men, NN2211 had no significant effect on glucagon levels during an intravenous glucose tolerance test.

    In plain wordsIn healthy men, liraglutide (NN2211) had no significant effect on glucagon during a glucose tolerance test.

    Peptide
    Liraglutide
    Outcome
    No significant changeGlucagon level during IVGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Endocrine and hormones
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    but there was no significant effect on glucagon levels.
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In healthy men, NN2211 had no significant effect on glucose levels during an intravenous glucose tolerance test.

    In plain wordsIn healthy men, liraglutide (NN2211) had no significant effect on blood glucose during a glucose tolerance test.

    Peptide
    Liraglutide
    Outcome
    No significant changeGlucose level during IVGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Although no significant effect was observed on glucose levels during the IVGTT
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In healthy men, NN2211 caused a dose-dependent increase in the glucose disappearance constant.

    In plain wordsIn healthy men, liraglutide (NN2211) sped up glucose clearance in a dose-dependent way during a glucose tolerance test.

    Peptide
    Liraglutide
    Outcome
    IncreaseGlucose disappearance constant during IVGTT
    Study

    n: not reported in source

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    there was a dose-dependent increase in the glucose disappearance constant.
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  9. 09HumanRandomized controlled trialSafety outcome

    In healthy men, NN2211 caused a higher incidence of adverse events than placebo.

    In plain wordsIn healthy men, liraglutide (NN2211) caused more side effects than placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseAdverse event incidence
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    there was a higher incidence of adverse events after active treatment compared with placebo treatment (notably headache, dizziness, nausea, and vomiting).
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  10. 10HumanRandomized controlled trialSafety outcome

    In healthy men, no serious adverse events were observed with NN2211.

    In plain wordsIn healthy men, liraglutide (NN2211) caused no serious side effects.

    Peptide
    Liraglutide
    Outcome
    No significant changeSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Whereas no serious adverse events were observed
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  11. 11HumanRandomized controlled trialSafety outcome

    In healthy men, headache was more common with NN2211 than with placebo.

    In plain wordsIn healthy men, headache was more common with liraglutide (NN2211) than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseHeadache
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Whereas no serious adverse events were observed, there was a higher incidence of adverse events after active treatment compared with placebo treatment (notably headache, dizziness, nausea, and vomiting).
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  12. 12HumanRandomized controlled trialSafety outcome

    In healthy men, dizziness was more common with NN2211 than with placebo.

    In plain wordsIn healthy men, dizziness was more common with liraglutide (NN2211) than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseDizziness
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Whereas no serious adverse events were observed, there was a higher incidence of adverse events after active treatment compared with placebo treatment (notably headache, dizziness, nausea, and vomiting).
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  13. 13HumanRandomized controlled trialSafety outcome

    In healthy men, nausea was more common with NN2211 than with placebo.

    In plain wordsIn healthy men, nausea was more common with liraglutide (NN2211) than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseNausea
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Whereas no serious adverse events were observed, there was a higher incidence of adverse events after active treatment compared with placebo treatment (notably headache, dizziness, nausea, and vomiting).
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.
  14. 14HumanRandomized controlled trialSafety outcome

    In healthy men, vomiting was more common with NN2211 than with placebo.

    In plain wordsIn healthy men, vomiting was more common with liraglutide (NN2211) than with placebo.

    Peptide
    Liraglutide
    Outcome
    IncreaseVomiting
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    1.25-20.0 microg/kg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Whereas no serious adverse events were observed, there was a higher incidence of adverse events after active treatment compared with placebo treatment (notably headache, dizziness, nausea, and vomiting).
    1 context sentence
    Summary · context
    In a double-blind, randomized dose, escalation, placebo-controlled study, healthy male subjects were enrolled at eight consecutive dose levels (1.25, 2.5, 5.0, 10.0, 12.5, 15.0, 17.5, and 20.0 microg/kg) with eight subjects per dose level at a 3:1 active:placebo randomization.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01507272

Safety and Tolerability of Liraglutide in Healthy Male Volunteers

Novo Nordisk A/Sn = 34Mar 1999 to Dec 1999

Diabetes · Healthy

Trial pageClinicalTrials.govUpdated 24 Jan 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 12:10 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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