Trial · NCT05928390
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluation of the efficacy of pasireotide s.c. on blood glucose concentration during an MMTT in patients with PBH after 12 weeks of treatment. | at baseline and at 12 weeks | Change in the blood glucose levels, as measured by the peak to nadir glucose AUC during MMTT |
| Secondary | KEY SECONDARY_CORE PHASE: Evaluation the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline | at baseline and at 12 weeks | Change from baseline in the rate of the composite (and individual components) of clinically significant hypoglycaemic events as measured as the frequency of level 2 hypoglycaemic events (glucose level \<54 mg/dL or 3.0 mmol/L) measured by SMBG OR the frequency of level 3 hypoglycaemic (requiring external assistance) events/4-weeks at 12 weeks of treatment with pasireotide vs placebo |
| Secondary | CORE PHASE: Evaluation of the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline and the MMTT | baseline and 12 weeks | Change in the nadir and peak of blood glucose levels, |
| Secondary | CORE PHASE: Evaluation of the efficacy of pasireotide s.c. on the change from baseline of level 2 hypoglycaemic events during a MMTT in patients with PBH | at 12 weeks | Change from baseline in the proportion of patients with no level 2 hypoglycaemic events (plasma glucose \<54 mg/dL or 3.0 mmol/L) at 60, 90, 105, 120, 135, 150, 165 and 180 min during a 3-hour MMTT |
| Secondary | CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (SF-36 score) | at 12 weeks | The 36-item Short Form Health Survey (SF-36) is a patient reported outcomes measure that consists of a 36-item self-report inventory. The SF-36 is an accepted metric for benchmarking indications against normative population-based statistics. It assesses health-related limitations in eight dimensions: physical functioning (PF), role limitations due to physical functioning (RP), bodily pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations due to emotional problems (RE), and mental health (MH). Two summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), can be calculated from the eight-dimension scores (scale scores). |
| Secondary | CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Dumping Score Questionnaire) | at 12 weeks | DSQ is a disease specific patient reported outcome (PRO) scale that was developed according to the FDA and EMEA guidelines. The questionnaire utilizes a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; and 4, very severe) to ask a patient to evaluate the intensity of 10 early dumping symptoms (within 30 minutes (\<30 minutes) after food ingestion). In addition, the questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (\>90 minutes) after food ingestion |
| Secondary | CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Patient Global Assessment) | at 12 weeks | It will incorporate a patient global assessment question: "Considering all the way that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study?" Patients Global Assessment will be measured utilizing a 7-point scale (from 1= a lot worse to 7= a lot better). |
| Secondary | CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Hypoglycaemia Fear Survey-II) from baseline | at 12 weeks | The Hypoglycaemia Fear Survey (HFS) originally was developed to measure behaviours and worries related to fear of hypoglycaemia (FOH) in adults with type 1 diabetes. Both the original HFS (HFS-I) and the revised version (HFS-II) are composed of two subscales, the Behaviour (HFS-B) and Worry (HFS-W). |
| Secondary | CORE PHASE: Evaluation of the safety profile of pasireotide s.c (AEs) | for 12 weeks | Incidence of AEs for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. |
| Secondary | EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (AEs) | for 36 weeks | Incidence of AEs for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. |
| Secondary | CORE PHASE: Evaluation of the safety profile of pasireotide s.c (Labs) | for 12 weeks | Incidence of laboratory findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in laboratory values and vital signs |
| Secondary | EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (Labs) | for 36 weeks | Incidence of laboratory findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in laboratory values and vital signs |
| Secondary | CORE PHASE: Evaluation of the safety profile of pasireotide s.c (ECG) | for 12 weeks | Incidence of ECG findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in ECG readings, |
| Secondary | EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period: (ECG) | for 36 weeks | Incidence of ECG findings for pasireotide s.c. 50 µg, or 100 µg or 200 µg tid or placebo tid. Changes from baseline in ECG readings, |
| Secondary | CORE PHASE: Evaluation of the safety profile of pasireotide s.c (imaging) | for 12 weeks | Changes from baseline in gallbladder imaging |
| Secondary | EXTENSION PHASE: evaluation of the safety profile of pasireotide s.c. during the whole extension period:(imaging) | for 36 weeks | Changes from baseline in gallbladder imaging |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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