The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men.

Agersø H, Jensen LB, Elbrønd B, Rolan P, Zdravkovic M

Diabetologia1 Feb 2002Cited by 391 (Europe PMC)

PMID11935150DOI10.1007/s00125-001-0719-zPepBankPUB-11935150

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 study17

17 results from studies that gave the peptide. 17 results from people.

01HumanRandomized controlled trialPharmacokinetics
In healthy men, the half-life of subcutaneous NN2211 (liraglutide) was 12.6 +/- 1.1 h.
In plain wordsIn healthy men, the half-life of liraglutide (NN2211) after an injection under the skin was about 12.6 hours.
Peptide
Liraglutide
Outcome
Not applicableElimination half-life
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Measurements
half-life
12.6 h
NN2211 s.c.
Source sentences
Summary
Following s. c. administration the half-life of NN2211 was found to be 12.6 +/- 1.1 h, with a subsequent accumulation index after a daily dose for seven days of 1.4-1.5.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515001
02HumanRandomized controlled trialPharmacokinetics
In healthy men, the accumulation index of NN2211 after a daily dose for seven days was 1.4-1.5.
In plain wordsIn healthy men, liraglutide (NN2211) built up in the blood after seven daily doses, with an accumulation index of 1.4-1.5.
Peptide
Liraglutide
Outcome
Not applicableAccumulation index after seven daily doses
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Measurements
accumulation index
1.4 to 1.5
daily dose for seven days
Source sentences
Summary
Following s. c. administration the half-life of NN2211 was found to be 12.6 +/- 1.1 h, with a subsequent accumulation index after a daily dose for seven days of 1.4-1.5.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515002
03HumanRandomized controlled trialPharmacokinetics
In healthy men, NN2211 AUC rose in proportion to dose.
In plain wordsIn healthy men, the total amount of liraglutide (NN2211) in the blood rose in proportion to the dose.
Peptide
Liraglutide
Outcome
IncreaseExposure (AUC) with increasing dose
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
There were dose-proportional increases in exposure (AUC and C(max)) with increasing doses.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515003
04HumanRandomized controlled trialPharmacokinetics
In healthy men, NN2211 Cmax rose in proportion to dose.
In plain wordsIn healthy men, the peak level of liraglutide (NN2211) in the blood rose in proportion to the dose.
Peptide
Liraglutide
Outcome
IncreaseExposure (Cmax) with increasing dose
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
There were dose-proportional increases in exposure (AUC and C(max)) with increasing doses.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515004
05HumanRandomized controlled trialEfficacy outcome
In healthy men, NN2211 caused no statistically significant difference from placebo in the 24-h glucose profile.
In plain wordsIn healthy men, liraglutide (NN2211) did not change 24-hour blood glucose significantly compared with placebo.
Peptide
Liraglutide
Outcome
No significant change24-h glucose profile
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
Overall, there were no statistically significant differences from placebo in the 24-h glucose and insulin profiles.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515005
06HumanRandomized controlled trialEfficacy outcome
In healthy men, NN2211 caused no statistically significant difference from placebo in the 24-h insulin profile.
In plain wordsIn healthy men, liraglutide (NN2211) did not change 24-hour insulin levels significantly compared with placebo.
Peptide
Liraglutide
Outcome
No significant change24-h insulin profile
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
Overall, there were no statistically significant differences from placebo in the 24-h glucose and insulin profiles.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515006
07HumanRandomized 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
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
In subjects treated with NN2211 rather than placebo, there was a higher incidence of adverse events, most notably dizziness and adverse events related to the gastrointestinal system.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515007
08HumanRandomized 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
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
In subjects treated with NN2211 rather than placebo, there was a higher incidence of adverse events, most notably dizziness and adverse events related to the gastrointestinal system.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515008
09HumanRandomized controlled trialSafety outcome
In healthy men, adverse events related to the gastrointestinal system were more common with NN2211 than with placebo.
In plain wordsIn healthy men, stomach and gut side effects were more common with liraglutide (NN2211) than with placebo.
Peptide
Liraglutide
Outcome
IncreaseGastrointestinal adverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
In subjects treated with NN2211 rather than placebo, there was a higher incidence of adverse events, most notably dizziness and adverse events related to the gastrointestinal system.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515009
10HumanRandomized controlled trialSafety outcome
In healthy men, no serious adverse events occurred 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
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
There were no serious adverse events
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515010
11HumanRandomized controlled trialSafety outcome
In healthy men, three subjects were withdrawn because of dizziness, fever and nausea.
In plain wordsIn healthy men, three people stopped the study because of dizziness, fever or nausea.
Peptide
Liraglutide
Outcome
IncreaseWithdrawals due to adverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
three subjects were nonetheless withdrawn because of dizziness, fever and nausea.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515011
12HumanRandomized controlled trialSafety outcome
In healthy men, NN2211 caused no clinically relevant changes in vital signs.
In plain wordsIn healthy men, liraglutide (NN2211) caused no clinically relevant changes in vital signs.
Peptide
Liraglutide
Outcome
No significant changeVital signs
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
There were no clinically relevant changes in vital signs, ECG parameters, physical examination or safety laboratory parameters.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515012
13HumanRandomized controlled trialSafety outcome
In healthy men, NN2211 caused no clinically relevant changes in ECG parameters.
In plain wordsIn healthy men, liraglutide (NN2211) caused no clinically relevant changes in heart tracings (ECG).
Peptide
Liraglutide
Outcome
No significant changeECG parameters
Study
n: not reported in source
Outcome group
Adverse events · Cardiovascular
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
There were no clinically relevant changes in vital signs, ECG parameters, physical examination or safety laboratory parameters.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515013
14HumanRandomized controlled trialSafety outcome
In healthy men, NN2211 caused no clinically relevant changes in safety laboratory parameters.
In plain wordsIn healthy men, liraglutide (NN2211) caused no clinically relevant changes in safety blood and urine tests.
Peptide
Liraglutide
Outcome
No significant changeSafety laboratory parameters
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
There were no clinically relevant changes in vital signs, ECG parameters, physical examination or safety laboratory parameters.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515014
15HumanRandomized controlled trialSafety outcome
In healthy men, NN2211 caused no clinically relevant changes in physical examination.
In plain wordsIn healthy men, liraglutide (NN2211) caused no clinically relevant changes at physical examination.
Peptide
Liraglutide
Outcome
No significant changePhysical examination
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
There were no clinically relevant changes in vital signs, ECG parameters, physical examination or safety laboratory parameters.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515015
16HumanRandomized controlled trialOther
In healthy men, actively treated subjects had significantly lower diuresis.
In plain wordsIn healthy men, people given liraglutide (NN2211) passed significantly less urine than people given placebo.
Peptide
Liraglutide
Outcome
DecreaseDiuresis
Study
n: not reported in source
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
A significantly lower diuresis was observed in the actively treated subjects
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515016
17HumanRandomized controlled trialOther
In healthy men, lower diuresis with NN2211 came without a clinically relevant change in packed cell volume.
In plain wordsIn healthy men, liraglutide (NN2211) did not clearly change packed cell volume in the blood.
Peptide
Liraglutide
Outcome
No significant changePacked cell volume
Study
n: not reported in source
Outcome group
Kidney function · Whole body
Studied dose
1.25-12.5 microg/kg · subcutaneous · seven daysAs given in this study (human).
Source sentences
Summary
without a clinically relevant change in packed cell volume.
1 context sentence(design, population, supporting numbers)
Summary · context
In a double-blind, randomized, dose escalation, placebo controlled study, healthy male subjects were enrolled at five consecutive dose levels of NN2211 (1.25, 5.0, 7.5, 10.0, 12.5 microg/kg).
Report a problemFND-1193515017

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 1NCT01507285

Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes

Novo Nordisk A/Sn = 24Aug 1999 to Nov 1999

Diabetes · Diabetes Mellitus, Type 2 · Healthy

Trial page ClinicalTrials.govUpdated 2 Nov 2023

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.

Version 2Current
12 Oct 2026, 12:10 UTC
Study results updated
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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