Rybelsus Clinical Trials: PIONEER Results in Plain English
- Major trials here
- 2
- Heart events, PIONEER 6
- 21% lower risk
Rybelsus overview
Its half-life is about 1 week. Once 7 d pass, half is gone; five half-lives (35 d) leave about 3%.
In PIONEER 1, people with type 2 diabetes lost 3.7 kg after 26 weeks, compared with 1.4 kg on placebo.
Monthly prices in US dollars include the list price and self-pay offers, all taken from the maker's price page.
Sources: FDA label (DailyMed), healthsystemtracker.org, Novo Nordisk pricing, Novo Nordisk.
Every trial in one table
Each trial name links to its ClinicalTrials.gov record.
| Trial | Who was in it | People | Weeks | Compared with | Main result | In the label as | NCT number |
|---|---|---|---|---|---|---|---|
| PIONEER 6 | Adults with type 2 diabetes and a high heart risk | 3,183 | Not listed | placebo | Heart attack, stroke or death from heart disease | Not listed | NCT02692716 |
| SOUL | Adults aged 50 and older with type 2 diabetes and either heart or kidney disease | 9,650 | Not listed | placebo | Heart attack, stroke or death from heart disease | Not listed | NCT03914326 |
Trials involving heart, kidney and other outcomes
| Trial | What it measured | Result | Compared with | Length |
|---|---|---|---|---|
| PIONEER 6 | Heart attack, stroke or death from heart disease | 3.8% vs 4.8% 21% lower risk | Placebo | Not listed |
| SOUL | Heart attack, stroke or death from heart disease | 12% vs 13.8% 14% lower risk | Placebo | 47.5 months (mean follow-up) |
Sources: SOUL (PubMed) and PIONEER 6 (PubMed).
Safety signals
These serious risks are warnings in the Rybelsus label:
- A boxed warning concerns thyroid C-cell tumors. In rodents, it led to thyroid C-cell tumors. Whether people develop them from it is unknown. If medullary thyroid cancer (MTC) is in your personal or family history, do not use it, and do not use it if you have MEN 2.
- Inflammation of the pancreas The medicine can inflame the pancreas. Stop taking it and get care if severe stomach pain will not stop. The pain can sometimes spread to your back.
- Diabetic eye disease may worsen. For people with type 2 diabetes, diabetic eye disease may worsen, especially if blood sugar falls quickly. Eye checks matter if you already have this condition.
- Low blood sugar. This medicine raises the risk of low blood sugar when combined with insulin or a sulfonylurea, and those doses may need lowering.
- Fluid loss can harm the kidneys. When vomiting or diarrhea causes fluid loss, kidney injury can result. Heavy fluid loss must be reported.
- Severe stomach and gut reactions People often have side effects in the stomach and gut, and they may be severe. It is not recommended if you have severe gastroparesis.
Source: FDA label (DailyMed).
Source: FDA label (DailyMed).
Semaglutide Trials now recruiting
Find recruiting semaglutide trials on ClinicalTrials.gov. After filtering by your state, discuss travel and costs with the study team.