Trial · NCT05928390
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
NCT05928390, Phase 2, Active not recruiting, RECORDATI GROUP
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia. Trials, record NCT05928390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05928390
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
- NCT number
- NCT05928390
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- RECORDATI GROUP
- Conditions
- Post-Bariatric Hypoglycemia
- Interventions
- Pasireotide Diaspartate
- First posted
- 2023-07-03
- Last updated
- 2026-09-17
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05928390
GET https://conductscience.org/api/trials/v1/NCT05928390/registered