Semaglutide for Cystic Fibrosis-Related Diabetes

Overseen By Brooke Noren

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Minnesota

Must be taking: Insulin

Must not be taking: Systemic glucocorticoids

Disqualifiers: Thyroid cancer, Pulmonary exacerbation, GI problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 15 weeks

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with cystic fibrosis related diabetes (CFRD).

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, it is an add-on therapy to insulin, so you will continue your insulin treatment.

What data supports the idea that Semaglutide for Cystic Fibrosis-Related Diabetes is an effective drug?

The available research shows that Semaglutide is effective in controlling blood sugar levels in patients with type 2 diabetes, which is similar to cystic fibrosis-related diabetes. It helps lower blood sugar by increasing insulin release and also aids in weight loss. Although specific data for cystic fibrosis-related diabetes is limited, its success in managing type 2 diabetes suggests potential benefits for similar conditions. ^{1 2 3 4 5}

What safety data exists for semaglutide?

Semaglutide, marketed under names like Ozempic, Wegovy, and Rybelsus, has been evaluated for safety in several clinical trials, primarily for type 2 diabetes. The SUSTAIN clinical trial program demonstrated its safety and efficacy, showing better glucose-lowering activity and weight loss compared to other treatments. It is generally well-tolerated, with a focus on avoiding weight gain, hypoglycemia, and gastrointestinal side effects. While primarily studied for type 2 diabetes, its use in cystic fibrosis-related diabetes is being explored. ^{1 2 4 5 6}

Is the drug Semaglutide a promising treatment for Cystic Fibrosis-Related Diabetes?

Yes, Semaglutide is a promising treatment for Cystic Fibrosis-Related Diabetes because it helps control blood sugar levels, which is important for better health outcomes in patients with this condition. ^{1 2 5 7 8}

Research Team

Amir Moheet, MBBS

Principal Investigator

University of Minnesota

Eligibility Criteria

Adults over 18 with cystic fibrosis-related diabetes (CFRD), overweight/obese (BMI >26 kg/m2), on insulin, and with pancreatic insufficiency can join. They must not be pregnant or breastfeeding, have certain thyroid cancers or endocrine syndromes, severe liver/kidney disease, recent acute lung issues, chronic GI problems requiring hospitalization within a year, history of pancreatitis or gastroparesis, started new CFTR therapy in the last 24 weeks, have suicidal tendencies or eating disorders.

Inclusion Criteria

I am being treated for pancreatic insufficiency with enzyme replacement.

I am 18 or older with cystic fibrosis-related diabetes and on insulin.

You weigh more than what is considered healthy for your height.

Exclusion Criteria

Pregnancy or lactation

I have severe liver disease due to cystic fibrosis.

You have tried to hurt yourself on purpose in the past, or you are currently thinking about hurting yourself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly semaglutide therapy as an add-on to insulin for overweight/obese adults with CFRD

15 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants may be monitored for long-term safety and data analysis

24 months

Treatment Details

Interventions

• Semaglutide

Trial Overview The trial is testing Semaglutide as an additional treatment to insulin for adults with CFRD who are overweight. It's an open label study where all participants know they're receiving the medication to assess its safety and how well it's tolerated.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Amir Moheet

Lead Sponsor

Trials

2

Recruited

20+

Cystic Fibrosis Foundation

Collaborator

Trials

199

Recruited

37,800+

Findings from Research

In a patient with cystic fibrosis-related diabetes (CFRD), adding semaglutide, a GLP-1 receptor agonist, to basal insulin significantly improved glycemic control, reducing HbA1c from 9.1% to 6.7% within 3 months.

The treatment did not lead to any increase in plasma pancreatic enzyme concentrations, indicating a safe profile for semaglutide when used in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide in Cystic Fibrosis-Related Diabetes. Gnanapragasam, H., Mustafa, N., Bierbrauer, M., et al.[2022]

Semaglutide (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.

The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. Dhillon, S.[2019]

Oral semaglutide, particularly at doses of 14 mg or flexibly dosed, significantly reduced HbA1c levels and body weight in patients with type 2 diabetes compared to other treatments, especially in those with higher baseline HbA1c levels.

The safety profile of oral semaglutide was comparable to that of other treatments, although it was associated with a higher incidence of gastrointestinal adverse events, which were consistent across different patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Aroda, VR., Bauer, R., Christiansen, E., et al.[2022]

In the SUSTAIN 1 to 5 trials involving 3918 participants with type 2 diabetes, semaglutide significantly helped more individuals achieve their HbA1c targets (47% to 74%) compared to placebo (7% to 19%) and other active comparators (16% to 29%).

Semaglutide was effective in achieving these results while minimizing unwanted outcomes, such as weight gain, severe hypoglycaemia, and gastrointestinal side effects, making it a safer option for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. DeVries, JH., Desouza, C., Bellary, S., et al.[2022]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

In a 12-week trial involving 75 adults with type 2 diabetes, semaglutide significantly improved both first- and second-phase insulin secretion, indicating enhanced beta cell function.

Semaglutide also led to better glycaemic control, with reduced fasting and postprandial glucose levels, and was well tolerated by participants, suggesting it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Kapitza, C., Dahl, K., Jacobsen, JB., et al.[2022]

In a 52-week study involving 731 patients with type 2 diabetes, oral semaglutide significantly reduced HbA1c levels and body weight compared to placebo, demonstrating its efficacy when added to insulin with or without metformin.

The most common side effect of oral semaglutide was nausea, which was mostly mild to moderate, indicating a safety profile similar to other glucagon-like peptide 1 receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Zinman, B., Aroda, VR., Buse, JB., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Semaglutide in Cystic Fibrosis-Related Diabetes. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. [2022]

5. Belgium pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. [2022]