Trial · NCT02493517
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
NCT02493517, Phase 3, Completed, Ipsen; results first posted 2018-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly. Trials, record NCT02493517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02493517
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
- NCT number
- NCT02493517
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 128 participants, actual
- Lead sponsor
- Ipsen
- Conditions
- Acromegaly
- Interventions
- Lanreotide Autogel®, Lanreotide Acetate
- First posted
- 2015-07-09
- Last updated
- 2019-01-29
- Results first posted
- 2018-12-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The standardised mean change from Baseline in age-adjusted log-transformed IGF-1 standard deviation score (SDS) at EOST/EW is presented for subjects treated with both lanreotide Autogel and lanreotide PR. Back-transformed results are presented in addition to the results without back-transformation. For each subject the IGF-1 SDS value was calculated based on the z-score derivation: IGF-1 SDS = (IGF-1 - mean)/ standard deviation (SD), with mean and SD derived from the upper limit of normal (ULN) and lower limit of normal (LLN) margins for each age category. ULN = Mean + 2 SD; LLN = Mean - 2 SD. The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A negative change in the SDS indicates a decrease in the mean age-adjusted IGF-1 values. |
| Secondary | Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The percentage of subjects with normal age-adjusted IGF-1 levels at the EOST/EW Visit is presented for subjects treated with Lanreotide Autogel and Lanreotide PR. At baseline, all subjects had abnormal IGF-1 levels as per protocol entry criteria. |
| Secondary | Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The percentage of subjects with GH ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels \>2.5 mcg/L as per protocol entry criteria. |
| Secondary | The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The percentage of subjects with GH ≤1 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. At baseline, all subjects had GH levels \>2.5 mcg/L as per protocol entry criteria. |
| Secondary | Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The percentage of subjects with normal age-adjusted IGF-1 levels and who have GH levels \>1 mcg/L but ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. The calculation of percentages was based on the overall ITT population. At baseline, all subjects had abnormal IGF-1 levels and GH levels \>2.5 mcg/L as per protocol entry criteria. |
| Secondary | Mean Change From Baseline in GH Values at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The mean change from baseline in GH values at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. |
| Secondary | Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The percentage of subjects with at least a 20% reduction in the solid component of the tumour volume at the EOST/EW Visit compared to baseline is presented for the subgroup of subjects who had solid tumours at baseline. The tumour volume was measured by Magnetic Resonance Imaging (MRI) at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers. |
| Secondary | Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The median percentage change in the solid component of the tumour volume from baseline to the EOST/EW Visit is presented. The tumour volume was measured by MRI at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers. |
| Secondary | Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline | Baseline, Week 13 Visit and EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The percentage of subjects with at least one symptom of acromegaly at Week 13 and at the EOST/EW Visit compared with baseline is presented for subjects treated with lanreotide Autogel and lanreotide PR. The symptoms of acromegaly monitored included: headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The Per Protocol population consisted of all subjects who were randomised and treated with at least one baseline and at least one postbaseline assessment of the primary efficacy parameter and for whom no major protocol deviations occurred with impact on efficacy assessment. | SDS | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The Intention-To-Treat (ITT) population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Percentage of Subjects | NUMBER |
| SECONDARY | Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Percentage of Subjects | NUMBER |
| SECONDARY | The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Percentage of Subjects | NUMBER |
| SECONDARY | Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Percentage of Subjects | NUMBER |
| SECONDARY | Mean Change From Baseline in GH Values at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Subjects with data available at time of analysis are presented. | mcg/L | MEAN |
| SECONDARY | Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline. | Percentage of Subjects | NUMBER |
| SECONDARY | Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit | Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline. | Percentage change in tumour volume | MEDIAN |
| SECONDARY | Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline | Baseline, Week 13 Visit and EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group). | The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. | Percentage of Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | Lanreotide Autogel | Without back-transformation | -0.84 | Standard Error 0.15 | SDS |
| Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | Lanreotide PR | Without back-transformation | -0.52 | Standard Error 0.17 | SDS |
| Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | Lanreotide Autogel | With back transformation | 0.43 | Standard Error 1.16 | SDS |
| Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit | Lanreotide PR | With back transformation | 0.59 | Standard Error 1.19 | SDS |
| Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit | Lanreotide Autogel | 15.6 | Percentage of Subjects | ||
| Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit | Lanreotide PR | 9.4 | Percentage of Subjects | ||
| Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit | Lanreotide Autogel | 29.7 | Percentage of Subjects | ||
| Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit | Lanreotide PR | 31.3 | Percentage of Subjects | ||
| The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit | Lanreotide Autogel | 10.9 | Percentage of Subjects | ||
| The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit | Lanreotide PR | 9.4 | Percentage of Subjects |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lanreotide Autogel | 64 | |
| Overall Study | STARTED | Lanreotide PR | 64 | |
| Overall Study | COMPLETED | Lanreotide Autogel | 62 | |
| Overall Study | COMPLETED | Lanreotide PR | 57 | |
| Overall Study | NOT COMPLETED | Lanreotide Autogel | 2 | |
| Overall Study | NOT COMPLETED | Lanreotide PR | 7 |
Source ClinicalTrials.gov
Adverse events94
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Lanreotide Autogel | 51 | 64 | 194 |
| other | Diarrhoea | Gastrointestinal disorders | Lanreotide PR | 46 | 64 | 337 |
| other | Abdominal distension | Gastrointestinal disorders | Lanreotide Autogel | 22 | 64 | 67 |
| other | Abdominal distension | Gastrointestinal disorders | Lanreotide PR | 27 | 64 | 146 |
| other | Abdominal pain | Gastrointestinal disorders | Lanreotide Autogel | 18 | 64 | 40 |
| other | Abdominal pain | Gastrointestinal disorders | Lanreotide PR | 20 | 64 | 114 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lanreotide Autogel | 13 | 64 | 32 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lanreotide PR | 16 | 64 | 37 |
| other | Nausea | Gastrointestinal disorders | Lanreotide Autogel | 7 | 64 | 7 |
| other | Nausea | Gastrointestinal disorders | Lanreotide PR | 16 | 64 | 69 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lanreotide Autogel | 0 | 64 |
| Total, all-cause mortality | Lanreotide PR | 0 | 64 |
| Total, other adverse events | Lanreotide Autogel | 59 | 64 |
| Total, other adverse events | Lanreotide PR | 62 | 64 |
| Total, serious adverse events | Lanreotide Autogel | 1 | 64 |
| Total, serious adverse events | Lanreotide PR | 2 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32366244 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lanreotide Autogel vs Lanreotide PR: deaths from any cause | Trial comparisons |
| Lanreotide Autogel vs Lanreotide PR: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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