Acromegaly
Conditions
Keywords
Open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study
Brief summary
This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.
Detailed description
Non probability samples
Interventions
OTHERNon Interventional Observation
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Exclusion criteria
* Subjects treated with an investigational drug for treatment of acromegaly. * Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery. * Women who were pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events (SAE) and Adverse Events (AE) | Baseline up to 5 years | Long term safety of Somavert in treatment of patients with acromegaly |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Insulin-like Growth Factor I (IGF-I) | Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months | Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay). |
| IGF-I Values Within Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants who have IGF-I values within normal range (local laboratory, different assay). |
| IGF-I Values Above Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants who have IGF-I values above normal range (local laboratory, different assay). |
| Change From Baseline Hemoglobin A 1c (HbA 1c) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Change: HbA 1c at observation minus HbA 1c at baseline. |
| HbA 1c Values Within Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants who have HbA 1c values within normal range. |
| HbA 1c Values Below Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6) | Number of participants who have HbA 1c values below normal range. |
| Change From Baseline Glucose (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Change: glucose at observation minus glucose at baseline. |
| Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3) | Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline. |
| Glucose Values Within Normal Range (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants who have glucose values within normal range (fasting). |
| Glucose Values Below Normal Range (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants with glucose values below normal range (fasting). |
| Glucose Values Above Normal Range (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants with glucose values above normal range (fasting). |
| Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants with glucose values (2h oGTT) within normal range. |
| Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants with glucose values (2h oGTT) above normal range. |
| IGF-I Absolute Values | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | IGF-I absolute values (local laboratory, different assay). |
| Absolute Glucose Values (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Absolute Glucose values (fasting) |
| Absolute Glucose Values (2h oGTT) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT). |
| Absolute Hemoglobin A 1c (HbA 1c) Values | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Absolute value Hemoglobin A 1c (HbA 1c) |
| Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay). |
| Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay). |
| Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay). |
| Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay). |
| Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes |
| Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Change: HbA 1c at observation minus HbA 1c at baseline. |
| HbA 1c Values Within Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of Diabetic Patients with HbA 1c Values Within Normal Range. |
| HbA 1c Values Below Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of Diabetic Patients with HbA 1c Values Below Normal Range |
| HbA 1c Values Above Normal Range in Diabetic Patients | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of Diabetic Patients with HbA 1c Values Above Normal Range |
| Glucose Change From Baseline in Diabetic Patients (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Change: glucose at observation minus glucose at baseline |
| Absolute Glucose Values in Diabetic Patients (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Absolute Glucose Values in Patients with Diabetes (fasting) |
| Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range |
| Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range |
| Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. |
| Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. |
| Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. |
| Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. |
| Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. |
| Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. |
| Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible). |
| Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4) | Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life. |
| Mean Change From Baseline for Body Weight | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | Change: body weight at observation minus body weight at baseline |
| HbA 1c Values Above Normal Range | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Number of participants with HbA 1c values above normal range. |
| Change From Baseline for Systolic Blood Pressure (BP) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | Change: systolic blood pressure at observation minus systolic blood pressure at baseline |
| Change From Baseline in Ring Size | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Change from baseline: ring size at observation minus ring size at baseline |
| Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. |
| Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5) | Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender. |
| Change From Baseline for Diastolic Blood Pressure (BP) | Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5) | Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline |
Participant flow
Pre-assignment details
Somavert® (active ingredient: Pegvisomant 10/15/20 mg). Dose and schedule were at discretion of each treating physician. Safety evaluations based on all 311 patients who received at least one dose of Somavert® (safety set). Results from 270 patients in the intent-to-treat (ITT) population were analyzed to evaluate the efficacy of Somavert® therapy.
Participants by arm
| Arm | Count |
|---|---|
| Somavert® Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant) | 311 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Death | 7 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Other | 23 |
Baseline characteristics
| Characteristic | Somavert® |
|---|---|
| Age Continuous | 50.3 years STANDARD_DEVIATION 13.8 |
| Sex: Female, Male Female | 154 Participants |
| Sex: Female, Male Male | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 197 / — |
| serious Total, serious adverse events | 116 / — |
Outcome results
Primary
Serious Adverse Events (SAE) and Adverse Events (AE)
Long term safety of Somavert in treatment of patients with acromegaly
Time frame: Baseline up to 5 years
Population: Safety Population; all patients who received at least one dose of Somavert® during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Serious Adverse Events (SAE) and Adverse Events (AE) | Serious Adverse Events (SAE's) | 116 participants |
| Somavert® | Serious Adverse Events (SAE) and Adverse Events (AE) | Adverse Events (AE's) | 197 participants |
Secondary
Absolute Glucose Values (2h oGTT)
Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Absolute Glucose Values (2h oGTT) | Baseline (n=5) | 130.6 milligram per deciliter (mg/dl) | Standard Deviation 60.2 |
| Somavert® | Absolute Glucose Values (2h oGTT) | Follow-up 1 (n=3) | 145.3 milligram per deciliter (mg/dl) | Standard Deviation 71.8 |
| Somavert® | Absolute Glucose Values (2h oGTT) | Follow-up 2 (n=2) | 108.1 milligram per deciliter (mg/dl) | Standard Deviation 10.2 |
| Somavert® | Absolute Glucose Values (2h oGTT) | Follow-up 3 (n=2) | 112.6 milligram per deciliter (mg/dl) | Standard Deviation 3.8 |
Secondary
Absolute Glucose Values (Fasting)
Absolute Glucose values (fasting)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Absolute Glucose Values (Fasting) | Baseline (n=158) | 112.6 milligram per deciliter (mg/dl) | Standard Deviation 44.3 |
| Somavert® | Absolute Glucose Values (Fasting) | Follow-up 1 (n=121) | 104.5 milligram per deciliter (mg/dl) | Standard Deviation 42.6 |
| Somavert® | Absolute Glucose Values (Fasting) | Follow-up 2 (n=103) | 98.7 milligram per deciliter (mg/dl) | Standard Deviation 34 |
| Somavert® | Absolute Glucose Values (Fasting) | Follow-up 3 (n=70) | 95.2 milligram per deciliter (mg/dl) | Standard Deviation 17.6 |
| Somavert® | Absolute Glucose Values (Fasting) | Follow-up 4 (n=33) | 105.9 milligram per deciliter (mg/dl) | Standard Deviation 42.7 |
| Somavert® | Absolute Glucose Values (Fasting) | Follow-up 5 (n=8) | 107.5 milligram per deciliter (mg/dl) | Standard Deviation 31.1 |
Secondary
Absolute Glucose Values in Diabetic Patients (Fasting)
Absolute Glucose Values in Patients with Diabetes (fasting)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Absolute Glucose Values in Diabetic Patients (Fasting) | Baseline (n=51) | 142.1 milligram per deciliter (mg/dl) | Standard Deviation 62.3 |
| Somavert® | Absolute Glucose Values in Diabetic Patients (Fasting) | Follow-up 1 (n=42) | 131.0 milligram per deciliter (mg/dl) | Standard Deviation 59.4 |
| Somavert® | Absolute Glucose Values in Diabetic Patients (Fasting) | Follow-up 2 (n=37) | 112.9 milligram per deciliter (mg/dl) | Standard Deviation 49.7 |
| Somavert® | Absolute Glucose Values in Diabetic Patients (Fasting) | Follow-up 3 (n=21) | 101.9 milligram per deciliter (mg/dl) | Standard Deviation 21.7 |
| Somavert® | Absolute Glucose Values in Diabetic Patients (Fasting) | Follow-up 4 (n=13) | 130.6 milligram per deciliter (mg/dl) | Standard Deviation 58.9 |
| Somavert® | Absolute Glucose Values in Diabetic Patients (Fasting) | Follow-up 5 (n=3) | 120.7 milligram per deciliter (mg/dl) | Standard Deviation 52.3 |
Secondary
Absolute Hemoglobin A 1c (HbA 1c) Values
Absolute value Hemoglobin A 1c (HbA 1c)
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Absolute Hemoglobin A 1c (HbA 1c) Values | Follow-up 3 (n=80) | 6.0 percent (%) | Standard Deviation 1.1 |
| Somavert® | Absolute Hemoglobin A 1c (HbA 1c) Values | Baseline (n=166) | 6.2 percent (%) | Standard Deviation 1.2 |
| Somavert® | Absolute Hemoglobin A 1c (HbA 1c) Values | Follow-up 1 (n=124) | 6.0 percent (%) | Standard Deviation 1.1 |
| Somavert® | Absolute Hemoglobin A 1c (HbA 1c) Values | Follow-up 2 (n=123) | 6.1 percent (%) | Standard Deviation 1.1 |
| Somavert® | Absolute Hemoglobin A 1c (HbA 1c) Values | Follow-up 4 (n=41) | 6.1 percent (%) | Standard Deviation 1.1 |
| Somavert® | Absolute Hemoglobin A 1c (HbA 1c) Values | Follow-up 5 (n=10) | 6.1 percent (%) | Standard Deviation 0.9 |
Secondary
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Baseline (n=67) | 7.0 percent (%) | Standard Deviation 1.4 |
| Somavert® | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 1 (n=58) | 6.6 percent (%) | Standard Deviation 1.2 |
| Somavert® | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 2 (n=60) | 6.5 percent (%) | Standard Deviation 1.2 |
| Somavert® | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 3 (n=36) | 6.6 percent (%) | Standard Deviation 1.3 |
| Somavert® | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 4 (n=21) | 6.6 percent (%) | Standard Deviation 1.3 |
| Somavert® | Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 5 (n=5) | 6.6 percent (%) | Standard Deviation 1 |
Secondary
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Baseline (n=78) | 478.8 micrograms per liter (ug/l) | Standard Deviation 264.6 |
| Somavert® | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 1 (n=75) | 276.4 micrograms per liter (ug/l) | Standard Deviation 145.9 |
| Somavert® | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 2 (n=67) | 293.2 micrograms per liter (ug/l) | Standard Deviation 212.3 |
| Somavert® | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 3 (n=44) | 239.3 micrograms per liter (ug/l) | Standard Deviation 142.6 |
| Somavert® | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 4 (n=24) | 242.5 micrograms per liter (ug/l) | Standard Deviation 115.5 |
| Somavert® | Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 5 (n=4) | 311.3 micrograms per liter (ug/l) | Standard Deviation 203.9 |
Secondary
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement; n=129).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Somavert® | Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population | 16.4 milligram (mg) |
Secondary
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy. Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration. Model included terms for IGF-I, growth hormone, age, weight and gender.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: The safety evaluations were based on all 311 patients who received at least one dose of Somavert® (safety set).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Somavert® | Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population | 16.8 milligram (mg) |
Secondary
Change From Baseline for Diastolic Blood Pressure (BP)
Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Change From Baseline for Diastolic Blood Pressure (BP) | Follow-up 1 (n=217) | -1.0 millimeters per mercury (mmHg) | Standard Deviation 11 |
| Somavert® | Change From Baseline for Diastolic Blood Pressure (BP) | Follow-up 2 (n=189) | -1.2 millimeters per mercury (mmHg) | Standard Deviation 13 |
| Somavert® | Change From Baseline for Diastolic Blood Pressure (BP) | Follow-up 3 (n=124) | -1.5 millimeters per mercury (mmHg) | Standard Deviation 13.4 |
| Somavert® | Change From Baseline for Diastolic Blood Pressure (BP) | Follow-up 4 (n=64) | 1.8 millimeters per mercury (mmHg) | Standard Deviation 15.2 |
| Somavert® | Change From Baseline for Diastolic Blood Pressure (BP) | Follow-up 5 (n=15) | 2.5 millimeters per mercury (mmHg) | Standard Deviation 15.1 |
Secondary
Change From Baseline for Systolic Blood Pressure (BP)
Change: systolic blood pressure at observation minus systolic blood pressure at baseline
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Change From Baseline for Systolic Blood Pressure (BP) | Follow-up 1 (n=217) | -0.1 millimeters Mercury (mmHg) | Standard Deviation 17.2 |
| Somavert® | Change From Baseline for Systolic Blood Pressure (BP) | Follow-up 2 (n=189) | -2.9 millimeters Mercury (mmHg) | Standard Deviation 18.1 |
| Somavert® | Change From Baseline for Systolic Blood Pressure (BP) | Follow-up 3 (n=124) | -4.3 millimeters Mercury (mmHg) | Standard Deviation 19.2 |
| Somavert® | Change From Baseline for Systolic Blood Pressure (BP) | Follow-up 4 (n=65) | 2.1 millimeters Mercury (mmHg) | Standard Deviation 21.4 |
| Somavert® | Change From Baseline for Systolic Blood Pressure (BP) | Follow-up 5 (n=15) | 8.4 millimeters Mercury (mmHg) | Standard Deviation 15.4 |
Secondary
Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Follow-up 1 (n=3) | -1.5 milligram per deciliter (mg/dl) | Standard Deviation 38.7 |
| Somavert® | Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Follow-up 2 (n=2) | -56.8 milligram per deciliter (mg/dl) | Standard Deviation 85.4 |
| Somavert® | Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)> | Follow-up 3 (n=2) | -61.3 milligram per deciliter (mg/dl) | Standard Deviation 79 |
Secondary
Change From Baseline Glucose (Fasting)
Change: glucose at observation minus glucose at baseline.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Change From Baseline Glucose (Fasting) | Follow-up 1 (n=121) | -11.6 milligram per deciliter (mg/dl) | Standard Deviation 39.6 |
| Somavert® | Change From Baseline Glucose (Fasting) | Follow-up 2 (n=103) | -14.2 milligram per deciliter (mg/dl) | Standard Deviation 40.1 |
| Somavert® | Change From Baseline Glucose (Fasting) | Follow-up 3 (n=70) | -19.7 milligram per deciliter (mg/dl) | Standard Deviation 45.7 |
| Somavert® | Change From Baseline Glucose (Fasting) | Follow-up 4 (n=33) | -12.9 milligram per deciliter (mg/dl) | Standard Deviation 51 |
| Somavert® | Change From Baseline Glucose (Fasting) | Follow-up 5 (n=8) | -10.5 milligram per deciliter (mg/dl) | Standard Deviation 18.3 |
Secondary
Change From Baseline Hemoglobin A 1c (HbA 1c)
Change: HbA 1c at observation minus HbA 1c at baseline.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) | Follow-up 1 (n=124) | -0.3 percent (%) | Standard Deviation 0.9 |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) | Follow-up 2 (n=123) | -0.3 percent (%) | Standard Deviation 1 |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) | Follow-up 3 (n=80) | -0.3 percent (%) | Standard Deviation 1.1 |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) | Follow-up 4 (n=41) | -0.3 percent (%) | Standard Deviation 1.6 |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) | Follow-up 5 (n=10) | -0.0 percent (%) | Standard Deviation 0.7 |
Secondary
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Change: HbA 1c at observation minus HbA 1c at baseline.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 1 (n=58) | -0.4 percent (%) |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 2 (n=60) | -0.5 percent (%) |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 3 (n=36) | -0.5 percent (%) |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 4 (n=21) | -0.6 percent (%) |
| Somavert® | Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients | Follow-up 5 (n=5) | -0.2 percent (%) |
Secondary
Change From Baseline in Ring Size
Change from baseline: ring size at observation minus ring size at baseline
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Change From Baseline in Ring Size | Follow-up 1 (n=99) | 0.2 millimeters | Standard Deviation 4.7 |
| Somavert® | Change From Baseline in Ring Size | Follow-up 2 (n=82) | -0.8 millimeters | Standard Deviation 8.3 |
| Somavert® | Change From Baseline in Ring Size | Follow-up 3 (n=37) | -0.3 millimeters | Standard Deviation 11.8 |
| Somavert® | Change From Baseline in Ring Size | Follow-up 4 (n=16) | -6.1 millimeters | Standard Deviation 15.7 |
| Somavert® | Change From Baseline in Ring Size | Follow-up 5 (n=2) | 0.0 millimeters | Standard Deviation 0 |
Secondary
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).
Time frame: Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Change From Baseline Insulin-like Growth Factor I (IGF-I) | Follow-up 1 (n=243) | -200.3 micrograms per liter (ug/l) | Standard Deviation 239.1 |
| Somavert® | Change From Baseline Insulin-like Growth Factor I (IGF-I) | Follow-up 2 (n=202) | -202.6 micrograms per liter (ug/l) | Standard Deviation 327.7 |
| Somavert® | Change From Baseline Insulin-like Growth Factor I (IGF-I) | Follow-up 3 (n=131) | -273.7 micrograms per liter (ug/l) | Standard Deviation 251.3 |
| Somavert® | Change From Baseline Insulin-like Growth Factor I (IGF-I) | Follow-up 4 (n=71) | -319.6 micrograms per liter (ug/l) | Standard Deviation 234.7 |
| Somavert® | Change From Baseline Insulin-like Growth Factor I (IGF-I) | Follow-up 5 (n=18) | -296.6 micrograms per liter (ug/l) | Standard Deviation 189.6 |
Secondary
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Change: IGF-I concentration at observation minus IGF-I concentration at baseline. (local laboratory, different assay).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 1 (n=75) | -207.5 micrograms per liter (ug/l) |
| Somavert® | Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 2 (n=67) | -194.5 micrograms per liter (ug/l) |
| Somavert® | Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 3 (n=44) | -274.6 micrograms per liter (ug/l) |
| Somavert® | Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 4 (n=24) | -314.9 micrograms per liter (ug/l) |
| Somavert® | Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients | Follow-up 5 (n=4) | -90.5 micrograms per liter (ug/l) |
Secondary
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=108) | -0.1 score on scale |
| Somavert® | Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=89) | -0.4 score on scale |
| Somavert® | Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=60) | -0.0 score on scale |
| Somavert® | Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | -0.8 score on scale |
Secondary
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=59) | -0.4 score on scale |
| Somavert® | Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=106) | 0.2 score on scale |
| Somavert® | Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=88) | -0.5 score on scale |
| Somavert® | Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | -0.4 score on scale |
Secondary
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs. Scoring 0-10 (0 = worst and 10 = best possible).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=106) | -0.6 score on scale |
| Somavert® | Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=89) | -0.6 score on scale |
| Somavert® | Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=59) | -0.6 score on scale |
| Somavert® | Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | -0.5 score on scale |
Secondary
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=107) | -0.3 score on scale |
| Somavert® | Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=89) | -0.4 score on scale |
| Somavert® | Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=60) | -0.2 score on scale |
| Somavert® | Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | -0.7 score on scale |
Secondary
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=108) | -0.6 score on scale |
| Somavert® | Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=89) | -0.2 score on scale |
| Somavert® | Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=60) | 0.0 score on scale |
| Somavert® | Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | 0.6 score on scale |
Secondary
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 130 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=108) | -0.7 score on scale |
| Somavert® | Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=89) | -0.6 score on scale |
| Somavert® | Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=60) | -0.6 score on scale |
| Somavert® | Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | -0.8 score on scale |
Secondary
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Change: score at observation minus score at baseline. Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=105) | -0.6 score on scale |
| Somavert® | Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=88) | -0.8 score on scale |
| Somavert® | Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=60) | -0.8 score on scale |
| Somavert® | Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | -1.2 score on scale |
Secondary
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Total PASQ score: total score calculated as sum of items 1-6; range is 0-48. Change from baseline calculated as total score at observation minus total score at baseline. PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8. Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
Population: ITT Population; subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement). Data were available for 131 of the 270 ITT patients.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 1 (n=107) | -2.3 score on scale |
| Somavert® | Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 2 (n=89) | -2.7 score on scale |
| Somavert® | Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 3 (n=60) | -2.0 score on scale |
| Somavert® | Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ) | Follow-up 4 (n=14) | -3.5 score on scale |
Secondary
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Number of participants with glucose values (2h oGTT) above normal range.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Baseline (n=7) | 2 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Follow-up 1 (n=4) | 1 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Follow-up 2 (n=3) | 0 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Follow-up 3 (n=3) | 0 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Follow-up 4 (n=0) | 0 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range | Follow-up 5 (n=0) | 0 participants |
Secondary
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Number of participants with glucose values (2h oGTT) within normal range.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Baseline (n=7) | 5 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Follow-up 1 (n=4) | 3 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Follow-up 2 (n=3) | 3 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Follow-up 3 (n=3) | 3 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Follow-up 4 (n=0) | 0 participants |
| Somavert® | Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range | Follow-up 5 (n=0) | 0 participants |
Secondary
Glucose Change From Baseline in Diabetic Patients (Fasting)
Change: glucose at observation minus glucose at baseline
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Somavert® | Glucose Change From Baseline in Diabetic Patients (Fasting) | Follow-up 1 (n=42) | -17.2 milligram per deciliter (mg/dl) |
| Somavert® | Glucose Change From Baseline in Diabetic Patients (Fasting) | Follow-up 2 (n=37) | -24.9 milligram per deciliter (mg/dl) |
| Somavert® | Glucose Change From Baseline in Diabetic Patients (Fasting) | Follow-up 3 (n=21) | -50.7 milligram per deciliter (mg/dl) |
| Somavert® | Glucose Change From Baseline in Diabetic Patients (Fasting) | Follow-up 4 (n=13) | -14.8 milligram per deciliter (mg/dl) |
| Somavert® | Glucose Change From Baseline in Diabetic Patients (Fasting) | Follow-up 5 (n=3) | -17.7 milligram per deciliter (mg/dl) |
Secondary
Glucose Values Above Normal Range (Fasting)
Number of participants with glucose values above normal range (fasting).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Glucose Values Above Normal Range (Fasting) | Baseline (n=172) | 54 participants |
| Somavert® | Glucose Values Above Normal Range (Fasting) | Follow-up 1 (n=132) | 26 participants |
| Somavert® | Glucose Values Above Normal Range (Fasting) | Follow-up 2 (n=117) | 23 participants |
| Somavert® | Glucose Values Above Normal Range (Fasting) | Follow-up 3 (n=78) | 12 participants |
| Somavert® | Glucose Values Above Normal Range (Fasting) | Follow-up 4 (n=35) | 10 participants |
| Somavert® | Glucose Values Above Normal Range (Fasting) | Follow-up 5 (n=8) | 2 participants |
Secondary
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Baseline (n=57) | 33 participants |
| Somavert® | Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Follow-up 1 (n=47) | 19 participants |
| Somavert® | Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Follow-up 2 (n=42) | 17 participants |
| Somavert® | Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Follow-up 3 (n=25) | 7 participants |
| Somavert® | Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Follow-up 4 (n=14) | 8 participants |
| Somavert® | Glucose Values Above Normal Range in Diabetic Patients (Fasting) | Follow-up 5 (n=3) | 1 participants |
Secondary
Glucose Values Below Normal Range (Fasting)
Number of participants with glucose values below normal range (fasting).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Glucose Values Below Normal Range (Fasting) | Baseline (n=172) | 2 participants |
| Somavert® | Glucose Values Below Normal Range (Fasting) | Follow-up 1 (n=132) | 3 participants |
| Somavert® | Glucose Values Below Normal Range (Fasting) | Follow-up 2 (n=117) | 1 participants |
| Somavert® | Glucose Values Below Normal Range (Fasting) | Follow-up 3 (n=78) | 1 participants |
| Somavert® | Glucose Values Below Normal Range (Fasting) | Follow-up 4 (n=35) | 0 participants |
| Somavert® | Glucose Values Below Normal Range (Fasting) | Follow-up 5 (n=8) | 0 participants |
Secondary
Glucose Values Within Normal Range (Fasting)
Number of participants who have glucose values within normal range (fasting).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Glucose Values Within Normal Range (Fasting) | Baseline (n=172) | 116 participants |
| Somavert® | Glucose Values Within Normal Range (Fasting) | Follow-up 1 (n=132) | 103 participants |
| Somavert® | Glucose Values Within Normal Range (Fasting) | Follow-up 2 (n=117) | 93 participants |
| Somavert® | Glucose Values Within Normal Range (Fasting) | Follow-up 3 (n=78) | 65 participants |
| Somavert® | Glucose Values Within Normal Range (Fasting) | Follow-up 4 (n=35) | 25 participants |
| Somavert® | Glucose Values Within Normal Range (Fasting) | Follow-up 5 (n=8) | 6 participants |
Secondary
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Baseline (n= 57) | 24 participants |
| Somavert® | Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Follow-up 1 (n=47) | 28 participants |
| Somavert® | Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Follow-up 2 (n=42) | 25 participants |
| Somavert® | Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Follow-up 3 (n=25) | 18 participants |
| Somavert® | Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Follow-up 4 (n=14) | 6 participants |
| Somavert® | Glucose Values Within Normal Range in Diabetic Patients (Fasting) | Follow-up 5 (n=3) | 2 participants |
Secondary
HbA 1c Values Above Normal Range
Number of participants with HbA 1c values above normal range.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | HbA 1c Values Above Normal Range | Baseline (n=173) | 69 participants |
| Somavert® | HbA 1c Values Above Normal Range | Follow-up 1 (n=132) | 46 participants |
| Somavert® | HbA 1c Values Above Normal Range | Follow-up 2 (n=127) | 48 participants |
| Somavert® | HbA 1c Values Above Normal Range | Follow-up 3 (n=82) | 24 participants |
| Somavert® | HbA 1c Values Above Normal Range | Follow-up 4 (n=43) | 13 participants |
| Somavert® | HbA 1c Values Above Normal Range | Follow-up 5 (n=10) | 3 participants |
Secondary
HbA 1c Values Above Normal Range in Diabetic Patients
Number of Diabetic Patients with HbA 1c Values Above Normal Range
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | HbA 1c Values Above Normal Range in Diabetic Patients | Baseline (n=72) | 48 participant |
| Somavert® | HbA 1c Values Above Normal Range in Diabetic Patients | Follow-up 1 (n=64) | 38 participant |
| Somavert® | HbA 1c Values Above Normal Range in Diabetic Patients | Follow-up 2 (n=62) | 37 participant |
| Somavert® | HbA 1c Values Above Normal Range in Diabetic Patients | Follow-up 3 (n=38) | 21 participant |
| Somavert® | HbA 1c Values Above Normal Range in Diabetic Patients | Follow-up 4 (n=22) | 12 participant |
| Somavert® | HbA 1c Values Above Normal Range in Diabetic Patients | Follow-up 5 (n=5) | 2 participant |
Secondary
HbA 1c Values Below Normal Range
Number of participants who have HbA 1c values below normal range.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | HbA 1c Values Below Normal Range | Baseline (n=173) | 0 participants |
| Somavert® | HbA 1c Values Below Normal Range | Follow-up 1 (n=132) | 1 participants |
| Somavert® | HbA 1c Values Below Normal Range | Follow-up 2 (n=127) | 1 participants |
| Somavert® | HbA 1c Values Below Normal Range | Follow-up 3 (n=82) | 1 participants |
| Somavert® | HbA 1c Values Below Normal Range | Follow-up 4 (n=43) | 0 participants |
| Somavert® | HbA 1c Values Below Normal Range | Follow-up 5 (n=10) | 0 participants |
Secondary
HbA 1c Values Below Normal Range in Diabetic Patients
Number of Diabetic Patients with HbA 1c Values Below Normal Range
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | HbA 1c Values Below Normal Range in Diabetic Patients | Baseline (n=72) | 0 participant |
| Somavert® | HbA 1c Values Below Normal Range in Diabetic Patients | Follow-up 1 (n=64) | 1 participant |
| Somavert® | HbA 1c Values Below Normal Range in Diabetic Patients | Follow-up 2 (n=62) | 1 participant |
| Somavert® | HbA 1c Values Below Normal Range in Diabetic Patients | Follow-up 3 (n=38) | 0 participant |
| Somavert® | HbA 1c Values Below Normal Range in Diabetic Patients | Follow-up 4 (n=22) | 0 participant |
| Somavert® | HbA 1c Values Below Normal Range in Diabetic Patients | Follow-up 5 (n=5) | 0 participant |
Secondary
HbA 1c Values Within Normal Range
Number of participants who have HbA 1c values within normal range.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | HbA 1c Values Within Normal Range | Baseline (n=173) | 104 participant |
| Somavert® | HbA 1c Values Within Normal Range | Follow-up 1 (n=132) | 85 participant |
| Somavert® | HbA 1c Values Within Normal Range | Follow-up 2 (n=127) | 78 participant |
| Somavert® | HbA 1c Values Within Normal Range | Follow-up 3 (n=82) | 57 participant |
| Somavert® | HbA 1c Values Within Normal Range | Follow-up 4 (n=43) | 30 participant |
| Somavert® | HbA 1c Values Within Normal Range | Follow-up 5 (n=10) | 7 participant |
Secondary
HbA 1c Values Within Normal Range in Diabetic Patients
Number of Diabetic Patients with HbA 1c Values Within Normal Range.
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | HbA 1c Values Within Normal Range in Diabetic Patients | Baseline (n=72) | 24 participants |
| Somavert® | HbA 1c Values Within Normal Range in Diabetic Patients | Follow-up 1 (n=64) | 25 participants |
| Somavert® | HbA 1c Values Within Normal Range in Diabetic Patients | Follow-up 2 (n=62) | 24 participants |
| Somavert® | HbA 1c Values Within Normal Range in Diabetic Patients | Follow-up 3 (n=38) | 17 participants |
| Somavert® | HbA 1c Values Within Normal Range in Diabetic Patients | Follow-up 4 (n=22) | 10 participants |
| Somavert® | HbA 1c Values Within Normal Range in Diabetic Patients | Follow-up 5 (n=5) | 3 participants |
Secondary
IGF-I Absolute Values
IGF-I absolute values (local laboratory, different assay).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | IGF-I Absolute Values | Baseline (n=252) | 480.1 micrograms per liter (ug/l) | Standard Deviation 249.5 |
| Somavert® | IGF-I Absolute Values | Follow-up 1 (n=243) | 277.2 micrograms per liter (ug/l) | Standard Deviation 160.5 |
| Somavert® | IGF-I Absolute Values | Follow-up 2 (n=202) | 281.6 micrograms per liter (ug/l) | Standard Deviation 285 |
| Somavert® | IGF-I Absolute Values | Follow-up 3 (n=131) | 240.6 micrograms per liter (ug/l) | Standard Deviation 134.7 |
| Somavert® | IGF-I Absolute Values | Follow-up 4 (n=71) | 236.1 micrograms per liter (ug/l) | Standard Deviation 124.2 |
| Somavert® | IGF-I Absolute Values | Follow-up 5 (n=18) | 241.8 micrograms per liter (ug/l) | Standard Deviation 107.4 |
Secondary
IGF-I Values Above Normal Range
Number of participants who have IGF-I values above normal range (local laboratory, different assay).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | IGF-I Values Above Normal Range | Baseline (n=266) | 207 participant |
| Somavert® | IGF-I Values Above Normal Range | Follow-up 1 (n=261) | 105 participant |
| Somavert® | IGF-I Values Above Normal Range | Follow-up 2 (n=222) | 68 participant |
| Somavert® | IGF-I Values Above Normal Range | Follow-up 3 (n=147) | 39 participant |
| Somavert® | IGF-I Values Above Normal Range | Follow-up 4 (n=79) | 23 participant |
| Somavert® | IGF-I Values Above Normal Range | Follow-up 5 (n=21) | 7 participant |
Secondary
IGF-I Values Within Normal Range
Number of participants who have IGF-I values within normal range (local laboratory, different assay).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | IGF-I Values Within Normal Range | Baseline (n=266) | 59 participant |
| Somavert® | IGF-I Values Within Normal Range | Follow-up 1 (n=261) | 156 participant |
| Somavert® | IGF-I Values Within Normal Range | Follow-up 2 (n=222) | 154 participant |
| Somavert® | IGF-I Values Within Normal Range | Follow-up 3 (n=147) | 108 participant |
| Somavert® | IGF-I Values Within Normal Range | Follow-up 4 (n=79) | 56 participant |
| Somavert® | IGF-I Values Within Normal Range | Follow-up 5 (n=21) | 14 participant |
Secondary
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Baseline (n=81) | 67 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Follow-up 1 (n=80) | 39 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Follow-up 2 (n=74) | 27 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Follow-up 3 (n=49) | 14 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Follow-up 4 (n=26) | 10 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients | Follow-up 5 (n=5) | 2 participants |
Secondary
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Baseline (n=81) | 14 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Follow-up 1 (n=80) | 41 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Follow-up 2 (n=74) | 47 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Follow-up 3 (n=49) | 35 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Follow-up 4 (n=26) | 16 participants |
| Somavert® | Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients | Follow-up 5 (n=5) | 3 participants |
Secondary
Mean Change From Baseline for Body Weight
Change: body weight at observation minus body weight at baseline
Time frame: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
Population: Intent to Treat (ITT) Population, subjects who received at least one dose of Somavert during the observation period and had baseline and at least one post baseline efficacy measurement (n=number of subjects with efficacy measurement).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Somavert® | Mean Change From Baseline for Body Weight | Follow-up 1 (n=213) | 0.0 kilogram (kg) | Standard Deviation 5.2 |
| Somavert® | Mean Change From Baseline for Body Weight | Follow-up 2 (n=185) | 0.6 kilogram (kg) | Standard Deviation 6 |
| Somavert® | Mean Change From Baseline for Body Weight | Follow-up 3 (n=118) | 2.1 kilogram (kg) | Standard Deviation 7.4 |
| Somavert® | Mean Change From Baseline for Body Weight | Follow-up 4 (n=61) | 1.6 kilogram (kg) | Standard Deviation 7.7 |
| Somavert® | Mean Change From Baseline for Body Weight | Follow-up 5 (n=13) | 3.0 kilogram (kg) | Standard Deviation 8.4 |