Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly.

Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B

Clinical endocrinology31 Jan 2008Cited by 53 (Europe PMC)

PMID18248639PMCIDPMC2610402DOI10.1111/j.1365-2265.2008.03208.xPepBankPUB-18248639

Summary

BackgroundAn essential criterion for control of acromegaly is normalization of IGF-I levels. Somatostatin analogues act to suppress IGF-I and GH levels.ObjectiveTo assess the efficacy and safety of 48 weeks titrated dosing of lanreotide Autogel.DesignOpen-label, multicentre, phase III, 48-week trial.MethodsPatients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited. Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels. Intention-to-treat analysis was performed to determine the proportion of patients with normalized age-adjusted IGF-I levels at study end. Secondary evaluations included GH levels, clinical acromegaly signs and safety.ResultsFifty-seven of 63 patients completed the study. Lanreotide Autogel resulted in normalized age-adjusted IGF-I levels in 27 patients (43%, 95% CI 31-55). Mean GH levels decreased from 6.2 to 1.5 microg/l at study end, with 53 of 62 patients (85%) having GH levels < or = 2.5 microg/l (95% CI 76.7-94.3) and 28 of 62 patients (45%) with levels < 1 microg/l (95% CI 32.8-57.6). Twenty-four (38%) had both normal IGF-I levels and GH levels < or = 2.5 microg/l. Acromegaly symptoms reduced significantly in most patients throughout the study. The most common adverse events were gastrointestinal, as expected for somatostatin analogues.ConclusionsUsing IGF-I as primary end-point, 48 weeks lanreotide Autogel treatment, titrated for optimal hormonal control, controlled IGF-I and GH levels effectively, reduced acromegaly symptoms and was well tolerated.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialEfficacy outcome
In active acromegaly, lanreotide normalized age-adjusted IGF-I in 27 patients, or 43%.
In plain wordsIn active acromegaly, lanreotide brought IGF-I into the normal range in 27 patients, or 43%.
Peptide
Lanreotide
Outcome
Not applicableNormalized age-adjusted IGF-I
Study
n = 63
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
90 mg for 16 weeks, then 60, 90 or 120 mg for 32 weeks, at 28-day intervals · 48 weeksAs given in this study (human).
Measurements
Patients with normalized age-adjusted IGF-I
27 patients
intention-to-treat
Patients with normalized age-adjusted IGF-I
43%
intention-to-treat
Confidence interval
31 to 55%
95% CI
Source sentences
Summary
Lanreotide Autogel resulted in normalized age-adjusted IGF-I levels in 27 patients (43%, 95% CI 31-55).
4 context sentences(design, population, supporting numbers)
Summary · context
Intention-to-treat analysis was performed to determine the proportion of patients with normalized age-adjusted IGF-I levels at study end.
Summary · context
Open-label, multicentre, phase III, 48-week trial.
Summary · context
Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited.
Summary · context
Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels.
Show in the study text Report a problemFND-1824863901
02HumanNon-randomized trialEfficacy outcome
In active acromegaly, 53 of 62 patients had GH at or below 2.5 microg/l after lanreotide.
In plain wordsIn active acromegaly, 53 of 62 patients had GH at or below 2.5 microg/l after lanreotide.
Peptide
Lanreotide
Outcome
Not applicableGH at or below 2.5 microg/l
Study
n = 62
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
90 mg for 16 weeks, then 60, 90 or 120 mg for 32 weeks, at 28-day intervals · 48 weeksAs given in this study (human).
Measurements
Patients with GH at or below 2.5 microg/l
53 patients
of 62 patients
Patients reaching threshold
85%
reported result
Confidence interval
76.7 to 94.3%
95% CI
Source sentences
Summary
Mean GH levels decreased from 6.2 to 1.5 microg/l at study end, with 53 of 62 patients (85%) having GH levels < or = 2.5 microg/l (95% CI 76.7-94.3) and 28 of 62 patients (45%) with levels < 1 microg/l (95% CI 32.8-57.6).
3 context sentences(design, population, supporting numbers)
Summary · context
Open-label, multicentre, phase III, 48-week trial.
Summary · context
Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited.
Summary · context
Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels.
Show in the study text Report a problemFND-1824863903
03HumanNon-randomized trialEfficacy outcome
In active acromegaly, 28 of 62 patients had GH below 1 microg/l after lanreotide.
In plain wordsIn active acromegaly, 28 of 62 patients had GH below 1 microg/l after lanreotide.
Peptide
Lanreotide
Outcome
Not applicableGH below 1 microg/l
Study
n = 62
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
90 mg for 16 weeks, then 60, 90 or 120 mg for 32 weeks, at 28-day intervals · 48 weeksAs given in this study (human).
Measurements
Patients with GH below 1 microg/l
28 patients
of 62 patients
Patients reaching threshold
45%
reported result
Confidence interval
32.8 to 57.6%
95% CI
Source sentences
Summary
Mean GH levels decreased from 6.2 to 1.5 microg/l at study end, with 53 of 62 patients (85%) having GH levels < or = 2.5 microg/l (95% CI 76.7-94.3) and 28 of 62 patients (45%) with levels < 1 microg/l (95% CI 32.8-57.6).
3 context sentences(design, population, supporting numbers)
Summary · context
Open-label, multicentre, phase III, 48-week trial.
Summary · context
Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited.
Summary · context
Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels.
Show in the study text Report a problemFND-1824863904
04HumanNon-randomized trialEfficacy outcome
In active acromegaly, mean GH decreased from 6.2 to 1.5 microg/l during lanreotide treatment.
In plain wordsIn active acromegaly, mean GH fell from 6.2 to 1.5 microg/l during lanreotide treatment.
Peptide
Lanreotide
Outcome
DecreaseMean GH
Study
n: not reported in source
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
90 mg for 16 weeks, then 60, 90 or 120 mg for 32 weeks, at 28-day intervals · 48 weeksAs given in this study (human).
Measurements
Baseline GH
6.2 microg/l
reported result
Final GH
1.5 microg/l
reported result
Source sentences
Summary
Mean GH levels decreased from 6.2 to 1.5 microg/l at study end, with 53 of 62 patients (85%) having GH levels < or = 2.5 microg/l (95% CI 76.7-94.3) and 28 of 62 patients (45%) with levels < 1 microg/l (95% CI 32.8-57.6).
3 context sentences(design, population, supporting numbers)
Summary · context
Open-label, multicentre, phase III, 48-week trial.
Summary · context
Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited.
Summary · context
Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels.
Show in the study text Report a problemFND-1824863902
05HumanNon-randomized trialEfficacy outcome
In active acromegaly, symptoms decreased significantly in most patients during lanreotide treatment.
In plain wordsIn active acromegaly, symptoms decreased significantly in most patients during lanreotide treatment.
Peptide
Lanreotide
Outcome
DecreaseAcromegaly symptoms
Study
n: not reported in source
Analysis
Secondary
Outcome group
Acromegaly Symptoms · Endocrine and hormones
Studied dose
90 mg for 16 weeks, then 60, 90 or 120 mg for 32 weeks, at 28-day intervals · 48 weeksAs given in this study (human).
Source sentences
Summary
Acromegaly symptoms reduced significantly in most patients throughout the study.
3 context sentences(design, population, supporting numbers)
Summary · context
Open-label, multicentre, phase III, 48-week trial.
Summary · context
Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited.
Summary · context
Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels.
Show in the study text Report a problemFND-1824863906
06HumanNon-randomized trialSafety outcome
In active acromegaly, gastrointestinal events were the most common adverse events during lanreotide treatment.
In plain wordsIn active acromegaly, digestive problems were the most common adverse events during lanreotide treatment.
Peptide
Lanreotide
Outcome
Not applicableGastrointestinal adverse events
Study
n: not reported in source
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
90 mg for 16 weeks, then 60, 90 or 120 mg for 32 weeks, at 28-day intervals · 48 weeksAs given in this study (human).
Source sentences
Summary
The most common adverse events were gastrointestinal, as expected for somatostatin analogues.
3 context sentences(design, population, supporting numbers)
Summary · context
Open-label, multicentre, phase III, 48-week trial.
Summary · context
Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited.
Summary · context
Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels.
Show in the study text Report a problemFND-1824863907
07HumanNon-randomized trialEfficacy outcome
In active acromegaly, 24 patients had normal IGF-I and GH at or below 2.5 microg/l with lanreotide.
In plain wordsIn active acromegaly, 24 patients had normal IGF-I and GH at or below 2.5 microg/l with lanreotide.
Peptide
Lanreotide
Outcome
Not applicableCombined IGF-I and GH control
Study
n: not reported in source
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
90 mg for 16 weeks, then 60, 90 or 120 mg for 32 weeks, at 28-day intervals · 48 weeksAs given in this study (human).
Measurements
Patients with both normal IGF-I and GH at or below 2.5 microg/l
24 patients
reported result
Combined hormonal control
38%
reported result
Source sentences
Summary
Twenty-four (38%) had both normal IGF-I levels and GH levels < or = 2.5 microg/l.
3 context sentences(design, population, supporting numbers)
Summary · context
Open-label, multicentre, phase III, 48-week trial.
Summary · context
Patients with active acromegaly (IGF-I levels > 1.3 times upper limit of age-adjusted normal range) were recruited.
Summary · context
Twelve injections of lanreotide Autogel were given at 28-day intervals: during the 16-week fixed-dose phase, patients received 90 mg; in the 32-week dose-titration phase, patients received 60, 90 or 120 mg according to GH and IGF-I levels.
Show in the study text Report a problemFND-1824863905

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 3NCT00210457

Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

Ipsenn = 63Sept 2000 to 15 Jul 2002

Acromegaly

Trial page ClinicalTrials.govUpdated 31 Mar 2020

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
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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