Trial Outcomes & Findings for Effects of Sandostatin LAR® in Acromegaly (NCT NCT01424241)
NCT ID: NCT01424241
Last Updated: 2024-07-24
Results Overview
Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2024-07-24
Participant Flow
Participant milestones
| Measure |
Open Label Dose Escalation Study of Sandostatin LAR Therapy
Acromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog.
In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk.
Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Open Label Dose Escalation Study of Sandostatin LAR Therapy
Acromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog.
In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk.
Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Time constraints
|
2
|
Baseline Characteristics
Effects of Sandostatin LAR® in Acromegaly
Baseline characteristics by cohort
| Measure |
Open Label Dose Escalation Study of Sandostatin LAR Therapy
n=21 Participants
Acromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog.
In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk.
Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
44.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
|
IGF-1 Level
|
336 ng/ml
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: This study was open to adult patients with active acromegaly, either newly diagnosed or failing other therapies who met the following inclusion and exclusion criteria.
Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)
Outcome measures
| Measure |
Open Label Dose Escalation of Sandostatin LAR Therapy
n=18 Participants
The study population is limited to patients with acromegaly presenting to the Neuroendocrine Unit.
|
Responders
n=10 Participants
Normal IGF-1 Group
|
Non Responders
n=8 Participants
Elevated IGF-1 Group
|
|---|---|---|---|
|
IGF-1 Level on Sandostatin LAR
|
336 ng/mL
Standard Deviation 209
|
186 ng/mL
Standard Deviation 42.4
|
487 ng/mL
Standard Deviation 200.4
|
SECONDARY outcome
Timeframe: Up to 9 monthsLevels of C-reactive protein (CRP) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.
Outcome measures
| Measure |
Open Label Dose Escalation of Sandostatin LAR Therapy
n=18 Participants
The study population is limited to patients with acromegaly presenting to the Neuroendocrine Unit.
|
Responders
n=10 Participants
Normal IGF-1 Group
|
Non Responders
n=8 Participants
Elevated IGF-1 Group
|
|---|---|---|---|
|
Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels
|
2.05 mg/L
Standard Deviation 3.5
|
2.89 mg/L
Standard Deviation 4.79
|
1.21 mg/L
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Up to 9 monthsLevels of homocysteine in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.
Outcome measures
| Measure |
Open Label Dose Escalation of Sandostatin LAR Therapy
n=18 Participants
The study population is limited to patients with acromegaly presenting to the Neuroendocrine Unit.
|
Responders
n=10 Participants
Normal IGF-1 Group
|
Non Responders
n=8 Participants
Elevated IGF-1 Group
|
|---|---|---|---|
|
Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels
|
9.98 µmol/L
Standard Deviation 5.8
|
10.57 µmol/L
Standard Deviation 5.56
|
9.40 µmol/L
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Up to 9 monthsLevels of lipid panel (cholesterol, triglycerides, and Lipoprotein A) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.
Outcome measures
| Measure |
Open Label Dose Escalation of Sandostatin LAR Therapy
n=18 Participants
The study population is limited to patients with acromegaly presenting to the Neuroendocrine Unit.
|
Responders
n=10 Participants
Normal IGF-1 Group
|
Non Responders
n=8 Participants
Elevated IGF-1 Group
|
|---|---|---|---|
|
Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels
LDL cholesterol
|
101.56 mg/dL
Standard Deviation 40.7
|
108.7 mg/dL
Standard Deviation 45.38
|
92.43 mg/dL
Standard Deviation 34.9
|
|
Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels
Triglycerides
|
95.2 mg/dL
Standard Deviation 36.2
|
88.38 mg/dL
Standard Deviation 38.13
|
103 mg/dL
Standard Deviation 35.1
|
|
Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels
Lipoprotein a
|
55.31 mg/dL
Standard Deviation 68.9
|
71.45 mg/dL
Standard Deviation 85.95
|
34.56 mg/dL
Standard Deviation 33.4
|
|
Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels
Total cholesterol
|
173.75 mg/dL
Standard Deviation 42.9
|
182.44 mg/dL
Standard Deviation 49.78
|
162.57 mg/dL
Standard Deviation 32.1
|
|
Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels
HDL Cholesterol
|
52.17 mg/dL
Standard Deviation 14.6
|
53.44 mg/dL
Standard Deviation 16.19
|
50.89 mg/dL
Standard Deviation 13.6
|
Adverse Events
Open Label Dose Escalation Study of Sandostatin LAR Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place