GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide.

Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH

The Journal of clinical endocrinology and metabolism5 Jan 2011Cited by 150 (Europe PMC)

PMID21209033DOI10.1210/jc.2010-2318PepBankPUB-21209033

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 study3

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialSafety outcome
In subjects with type 2 diabetes or nondiabetic obesity, serum calcitonin stayed at the low end of the normal range during liraglutide or control treatment, with geometric mean values no greater than 1.0 ng/liter at 2 years.
In plain wordsIn people with type 2 diabetes or obesity, blood calcitonin stayed low during liraglutide treatment.
Peptide
Liraglutide
Outcome
No significant changeSerum calcitonin concentration over time
Study
n: not reported in source
Comparator
Control therapy
Outcome group
Thyroid function · Endocrine and hormones
Studied dose
Dose not stated · up to 2 yearsAs given in this study (human).
Source sentences
Summary
Basal mean CT concentrations were at the low end of normal range in all treatment groups and remained low throughout the trials. At 2 yr, estimated geometric mean values were no greater than 1.0 ng/liter, well below upper normal ranges for males and females.
1 context sentence(design, population, supporting numbers)
Summary · context
Unstimulated serum CT concentrations were measured at 3-month intervals for no more than 2 yr in a series of trials in over 5000 subjects receiving liraglutide or control therapy.
Report a problemFND-2120903301
02HumanRandomized controlled trialSafety outcome
In subjects with type 2 diabetes or nondiabetic obesity, the proportion whose calcitonin rose above 20 ng/liter was very low in all treatment groups.
In plain wordsIn people with type 2 diabetes or obesity, very few had calcitonin rise above the 20 ng/liter cutoff in any group.
Peptide
Liraglutide
Outcome
No significant changeProportion of subjects with calcitonin above 20 ng/liter
Study
n: not reported in source
Comparator
Control therapy
Outcome group
Thyroid function · Endocrine and hormones
Studied dose
Dose not stated · up to 2 yearsAs given in this study (human).
Source sentences
Summary
Proportions of subjects whose CT levels increased above a clinically relevant cutoff of 20 ng/liter were very low in all groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Unstimulated serum CT concentrations were measured at 3-month intervals for no more than 2 yr in a series of trials in over 5000 subjects receiving liraglutide or control therapy.
Report a problemFND-2120903302
03HumanRandomized controlled trialSafety outcome
In subjects with type 2 diabetes or nondiabetic obesity, there was no consistent dose- or time-dependent relationship and no consistent difference in calcitonin between treatment groups.
In plain wordsIn people with type 2 diabetes or obesity, liraglutide did not consistently change calcitonin compared with control treatment.
Peptide
Liraglutide
Outcome
No significant changeCalcitonin difference between liraglutide and control groups, dose and time relationship
Study
n: not reported in source
Comparator
Control therapy
Outcome group
Thyroid function · Endocrine and hormones
Studied dose
Dose not stated · up to 2 yearsAs given in this study (human).
Source sentences
Summary
There was no consistent dose or time-dependent relationship and no consistent difference between treatment groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Unstimulated serum CT concentrations were measured at 3-month intervals for no more than 2 yr in a series of trials in over 5000 subjects receiving liraglutide or control therapy.
Report a problemFND-2120903303

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

Registered trials6

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

6 trials · 5 completed · 1 stopped early · 4 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00393718