Trial Outcomes & Findings for Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel (NCT NCT00447499)

Last Updated: 2020-11-20

Results Overview

The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

59 participants

Primary outcome timeframe

24 weeks

Results posted on

2020-11-20

Participant Flow

First patient enrolled on 6/28/2007 and last patient completed on 12/11/2008. The study enrolled patients with a diagnosis of acromegaly due to a pituitary tumor. patients were recruited from the patient populations of participating investigators and from referrals from other clinics and private practices. A competitive recruitment was used.

Patient had been treated with a long-acting somatostatin analog for at least 3 months prior to Screening, must have had IGF-1 levels \< 10% above the upper limit of normal range, OR the patient was somatostatin analog-naïve (if the patient was treated with a dopamine agonist, he/she must have been on the dose for \>= 3 months prior to Screening)

Participant milestones

Participant milestones
Measure	Somatuline Autogel (Lanreotide Acetate) Injection Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Overall Study STARTED	59
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Somatuline Autogel (Lanreotide Acetate) Injection Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Overall Study Adverse Event	1
Overall Study Patient Decision	4
Overall Study Sponsor Decision	1
Overall Study Physician Decision	1

Baseline Characteristics

Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=59 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Age, Continuous	53.1 Years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants
Dopamine Agonist Treatment Yes	11 Participants n=5 Participants
Dopamine Agonist Treatment No	33 Participants n=5 Participants
Dopamine Agonist Treatment Missing	15 Participants n=5 Participants
Previous Pituitary Surgery Yes	52 participants n=5 Participants
Previous Pituitary Surgery No	7 participants n=5 Participants
Prior Somatostatin Analogue Treatment Yes	38 participants n=5 Participants
Prior Somatostatin Analogue Treatment No	6 participants n=5 Participants
Prior Somatostatin Analogue Treatment Missing	15 participants n=5 Participants
Duration of Acromegaly	7.8 Years STANDARD_DEVIATION 6.7 • n=5 Participants
Time Since Last Pituitary Surgery	6.7 Years STANDARD_DEVIATION 6.2 • n=5 Participants
Time Since Last Somatostatin Analogue Treatment	78.8 Days STANDARD_DEVIATION 173.3 • n=5 Participants
Weight	93.0 Kg STANDARD_DEVIATION 23.8 • n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: All patients enrolled in the study. Patients either switched directly from octreotide (Switch patients, n = 33) or were somatostatin analogue treatment-naïve, or were not currently on octreotide treatment at study start (Other patients, n = 26).

Outcome measures

Outcome measures
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=54 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.	98 Percentage of Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Patients switched directly from octreotide.

Experienced Convenience of Somatuline® Autogel® Injections was assessed by the subject as: Very convenient; somewhat convenient; neither convenient nor inconvenient; Neither convenient nor inconvenient; Somewhat inconvenient; very inconvenient.

Outcome measures

Outcome measures
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=32 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Percentage of Switch Subjects Who Find Self-administration of Somatuline Autogel Convenient as Assessed by the Subject Convenience Questionnaire Score.	91 Percent of Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Patients switched directly from octreotide who had IGF-1 level measured at the end of study.

Blood sample was collected while subject is in a fasting state or non-fasting state for measuring the level of IGF-1.

Outcome measures

Outcome measures
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=32 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Percentage of Switch Subjects That Have IGF-1 Levels Within the Normal Range for Age and Gender at the End of the Study	94 Percent of Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Patients switched directly from octreotide who had GH level measured at the end of study.

Blood samples taken before and 60 and 120 min after glucose load from fasting patient.

Outcome measures

Outcome measures
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=26 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Percentage of Switch Subjects That Have Glucose Suppressed GH Levels ≤ 2.5 ng/ml at the End of the Study, Week 24/Termination.	89 Percent of Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: Patients switched directly from octreotide who had GH level measured at the end of study.

Blood samples taken before and 60 and 120 min after glucose load from fasting patient.

Outcome measures

Outcome measures
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=26 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Change of GH Concentration Levels From Basaeline to Week 24 in Switch Patients	-0.3 ng/mL Standard Deviation 1.3

SECONDARY outcome

Timeframe: 24 Weeks

Acromegaly symptoms are sweating, snoring, joint pain, headache and fatigue. Each symptom was scored as -2 = 'always', -1 = 'most of the time', 0 = 'sometimes', 1 = 'rarely and 2 = 'never'. The total score was used to evaluate symptom control in each patient at Week 0 and Week 24/Termination. The total worst score is -10 and best score is 10.

Outcome measures

Outcome measures
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=59 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Total Symptom Questionnaire Score at Week 24/Termination	0.9 On a Scale from -10 to 10 Standard Deviation 3.6

SECONDARY outcome

Timeframe: 24 weeks

Healthcare professional convenience questionnaires are: Confident the Subject Properly Administering the Injection; Subject Complained About Pain When Administering the Injection; Subject Appreciated the Option of Self-Injection at Home. Each Healthcare professional convenience questionnaire was scored -2, -1, 0, 1 and 2; from most negative to most positive response. A total score across all questions was calculated and was used to evaluate the convenience. The worst total score is -6 and best total score is 6.

Outcome measures

Outcome measures
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=56 Participants Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Total Health Care Professional Convenience Questionnaire Score at Week 24/Termination	4.6 On a Scale from -6 to 6 Standard Deviation 1.8

Adverse Events

Somatuline Autogel (Lanreotide Acetate) Injection

Serious events: 5 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=59 participants at risk Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Metabolism and nutrition disorders Obesity	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Abdominal pain	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Pancreatitis	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid gland Cancer	1.7% 1/59 • Number of events 1 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.

Other adverse events

Other adverse events
Measure	Somatuline Autogel (Lanreotide Acetate) Injection n=59 participants at risk Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
Gastrointestinal disorders Abdominal Pain	15.3% 9/59 • Number of events 17 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Abdominal Pain Upper	15.3% 9/59 • Number of events 11 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Constipation	5.1% 3/59 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Diarrhoea	47.5% 28/59 • Number of events 68 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Flatulence	8.5% 5/59 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Nausea	16.9% 10/59 • Number of events 13 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Stomach Discomfort	5.1% 3/59 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
General disorders Asthenia	5.1% 3/59 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
General disorders Fatigue	11.9% 7/59 • Number of events 14 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Gastrointestinal disorders Injection Site Irritation	8.5% 5/59 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
General disorders Injection Site Mass	6.8% 4/59 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
General disorders Injection Site Nodule	5.1% 3/59 • Number of events 9 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
General disorders Injection Site Pain	20.3% 12/59 • Number of events 18 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
General disorders Injection Site Pruritus	8.5% 5/59 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
General disorders Injection Site Swelling	8.5% 5/59 • Number of events 7 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Infections and infestations Influenza	5.1% 3/59 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Infections and infestations Nasopharyngitis	5.1% 3/59 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Musculoskeletal and connective tissue disorders Arthralgia	15.3% 9/59 • Number of events 15 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Musculoskeletal and connective tissue disorders Back Pain	13.6% 8/59 • Number of events 12 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Musculoskeletal and connective tissue disorders Muscle Spasms	6.8% 4/59 • Number of events 6 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Musculoskeletal and connective tissue disorders Myalgia	5.1% 3/59 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Musculoskeletal and connective tissue disorders Pain In Extremity	6.8% 4/59 • Number of events 12 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Nervous system disorders Dizziness	6.8% 4/59 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Nervous system disorders Headache	27.1% 16/59 • Number of events 37 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Nervous system disorders Paraesthesia	6.8% 4/59 • Number of events 4 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Psychiatric disorders Insomnia	5.1% 3/59 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 3/59 • Number of events 3 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.
Skin and subcutaneous tissue disorders Alopecia	6.8% 4/59 • Number of events 5 • Adverse events were collected until 30 days after last subject visit or until resolution. Adverse event collection for an individual subject was up to 8 months. Across study adverse event reporting continued for a total of 1 years 7 months.

Additional Information

Bert Bakker, MD, PhD.

Ipsen

Phone: +1 650 238 1669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place