In short
Pasireotide Diaspartate, also known as Pasireotide, is being studied in clinical trials as a potential treatment for post-bariatric hypoglycemia. This condition occurs in some patients who have undergone weight loss surgery and experience dangerously low blood sugar levels. The trial aims to assess the efficacy and safety of different doses of Pasireotide administered subcutaneously (under the skin) in managing this condition.
At a glance
- Drug Name
- Pasireotide Diaspartate (also known as Pasireotide)
- Condition Studied
- Post-Bariatric Hypoglycemia
- Administration Method
- Subcutaneous injection, three times daily before meals
- Doses Tested
- 50 μg, 100 μg, 200 μg
- Study Duration
- Up to 59 weeks (19-week core phase, 36-week extension, 4-week follow-up)
- Primary Outcome
- Change in blood glucose levels during meal test after 12 weeks of treatment
- Key Secondary Outcomes
- Rate of hypoglycemic events, duration of hypoglycemic events, quality of life measures
- Safety Assessments
- Adverse events, laboratory tests, ECG findings
What is Pasireotide Diaspartate?
Pasireotide Diaspartate, also known simply as Pasireotide, is a medication currently being studied for its potential to treat a condition called post-bariatric hypoglycemia. It comes in the form of injectable ampoules, which means it's a liquid medication that needs to be injected under the skin.
What Does Pasireotide Treat?
The primary focus of the current research on Pasireotide is its use in treating post-bariatric hypoglycemia. This is a condition that can occur in some people who have undergone bariatric surgery (weight loss surgery). After this type of surgery, some patients may experience episodes of low blood sugar (hypoglycemia), which can be dangerous if not managed properly.
How is Pasireotide Administered?
In the ongoing clinical trial, Pasireotide is being tested in three different doses: 50 micrograms (μg), 100 μg, and 200 μg. The medication is administered subcutaneously (under the skin) three times a day, specifically before each meal.
Current Clinical Trial
A clinical trial is currently underway to evaluate the effectiveness and safety of Pasireotide for post-bariatric hypoglycemia. Here are some key points about the trial:
- It's a Phase II study, which means it's testing the drug's effectiveness and looking for side effects in a larger group of people.
- The trial is double-blind and placebo-controlled. This means that some participants receive the actual drug while others receive a placebo (a substance with no active ingredients), and neither the participants nor the researchers know who is getting which until the end of the study. This helps ensure unbiased results.
- The total duration of participation for each patient is up to 59 weeks, divided into different phases:
- A 19-week core phase, including screening, a 4-week run-in period without treatment, and a 12-week blinded treatment phase
- A 36-week extension phase with open-label treatment
- A 4-week safety follow-up period without treatment
How Efficacy is Measured
The researchers are using several methods to determine if Pasireotide is effective:
- Blood glucose levels: The primary measure is the change in blood glucose levels during a test called the Mixed Meal Tolerance Test (MMTT) after 12 weeks of treatment.
- Hypoglycemic events: They're tracking the frequency and severity of low blood sugar episodes, categorized as Level 2 (glucose below 54 mg/dL) and Level 3 (requiring external assistance).
- Continuous Glucose Monitoring (CGM): This involves wearing a device that constantly measures blood sugar levels.
- Use of rescue therapy: They're monitoring how often patients need to use emergency treatments or eat extra carbohydrates to manage low blood sugar.
- Changes in hormones: The study is looking at how Pasireotide affects levels of insulin, glucagon, and GLP-1, which are hormones involved in blood sugar regulation.
Safety Profile
As with any medication, it's crucial to understand the potential side effects and safety concerns. The clinical trial is closely monitoring the safety profile of Pasireotide by tracking:
- Adverse events (side effects)
- Laboratory test results
- ECG findings (a test that checks the electrical activity of the heart)
This information will help determine if Pasireotide is safe for long-term use in patients with post-bariatric hypoglycemia.
Impact on Quality of Life
The researchers are also interested in how Pasireotide affects patients' overall quality of life. They're using several questionnaires to assess this:
- SF-36 Health Survey: This looks at various aspects of health and well-being, including physical functioning, pain, general health, vitality, social functioning, and mental health.
- Hypoglycemia Fear Survey-II: This assesses how much patients worry about or avoid activities due to fear of low blood sugar.
- Dumping Score Questionnaire: This evaluates symptoms related to rapid gastric emptying, which can occur after bariatric surgery.
- Patient Global Assessment: This allows patients to rate their overall condition on a scale from "a lot worse" to "a lot better".