Pancreatic Enzyme Replacement Therapy for Type 1 Diabetes

(CREON Trial)

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Vanderbilt University Medical Center

Must not be taking: Non-insulin glucose control

Disqualifiers: Celiac, Inflammatory bowel, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether pancreatic enzyme replacement therapy can help people with Type 1 Diabetes (T1D) better manage their blood sugar levels. Researchers believe that adding these enzymes might reduce post-meal blood sugar spikes, a common issue for those with T1D. Participants will receive either the enzyme treatment, CREON (a pancreatic enzyme replacement therapy), or a placebo (inactive substance) to compare results. Suitable candidates have had T1D for at least a year, receive care at a specific diabetes clinic, and currently use a continuous glucose monitor. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking diabetes research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using medications or supplements other than insulin to control blood glucose.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that CREON, a treatment that replaces pancreatic enzymes, is safe to use. Studies indicate that most people tolerate it well, experiencing only a few mild side effects, mostly related to digestion. For individuals with diabetes and exocrine pancreatic insufficiency, where the pancreas doesn't produce enough enzymes, CREON is both safe and effective. It aids digestion without significantly increasing the risk of low blood sugar. Overall, CREON is considered safe for managing conditions related to enzyme shortages. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 1 Diabetes?

Unlike the standard of care for Type 1 Diabetes, which typically involves insulin therapy, CREON is unique because it targets digestive issues by providing pancreatic enzyme replacement. Researchers are excited about CREON because it offers a potential dual benefit: managing blood sugar levels while also improving digestion and nutrient absorption, which can be a concern for people with Type 1 Diabetes. This approach could provide a more comprehensive management strategy for patients, addressing both metabolic and digestive aspects of the condition.

What evidence suggests that pancreatic enzyme replacement therapy might be an effective treatment for Type 1 Diabetes?

Research has shown that pancreatic enzyme replacement therapy, such as CREON, may help people with Type 1 Diabetes (T1D) better control their blood sugar. In this trial, some participants will receive CREON, which has improved nutrition and quality of life in cases of pancreatic insufficiency. It specifically helps reduce symptoms of low blood sugar in people with diabetes caused by pancreatic issues. For those with a smaller pancreas, enzyme replacement might help the body manage sugar better and reduce blood sugar fluctuations. Evidence indicates that enzyme therapy aids in managing blood sugar levels after meals in conditions like diabetes related to cystic fibrosis. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Moore, MD, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 1 Diabetes, who've had it for at least a year, use a continuous glucose monitor and smartphone, and get care from the Eskind Diabetes Clinic. They should have reduced pancreas size and not be pregnant or breastfeeding, on restrictive diets, using other diabetes meds besides insulin, or have celiac or bowel disease.

Inclusion Criteria

I use more than 0.7 units of insulin per kilogram of my body weight daily.

Willingness and ability to download and provide CGM and pump (if applicable) data

My pancreas is smaller than usual for my body weight.

Exclusion Criteria

I have a history of celiac disease or inflammatory bowel disease.

I use medication or supplements, not including insulin, to manage my blood sugar.

You are following a strict diet, like a very low carb diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CREON or placebo to assess glucose regulation and pancreatic exocrine insufficiency symptoms

4-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CREON

Trial Overview The study tests if CREON (pancreatic enzyme replacement) can help manage blood sugar in Type 1 Diabetes by improving glycemic response and reducing hypoglycemia compared to a placebo. Participants will provide data from their glucose monitors to see how well CREON works.

How Is the Trial Designed?

Group I: CREON Active Control 1 Intervention

CREON is a pancreatic enzyme replacement

Group II: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

In a study involving 54 patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis or pancreatic surgery, pancrelipase significantly improved fat absorption (CFA) and nitrogen absorption (CNA) compared to placebo, indicating its efficacy in treating maldigestion.

The safety profile of pancrelipase was comparable to that of placebo, with similar rates of treatment-emergent adverse events, suggesting it is a safe option for patients with EPI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. Whitcomb, DC., Lehman, GA., Vasileva, G., et al.[2022]

A new pancreatic enzyme preparation, Creon, demonstrated superior efficacy in reducing steatorrhea (fat in stool) compared to traditional pancreatin tablets, even with significantly lower lipase activity and dosage, achieving a 57% reduction in steatorrhea.

Patients using Creon experienced significant weight gain and a 70% reduction in steatorrhea after 30 days of treatment, indicating its effectiveness in managing malabsorption due to pancreatic insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of a new microencapsulated pancreatin versus a conventional preparation, in the treatment of steatorrhea of pancreatic origin]. Aparisi, L., Rodrigo, JM., Serra, MA., et al.[2009]

Pancrelipase delayed-release capsules (CREON) have been shown to significantly improve fat and nitrogen absorption, as well as clinical symptoms in patients with exocrine pancreatic insufficiency (EPI) due to conditions like cystic fibrosis and chronic pancreatitis, based on double-blind, randomized trials.

CREON is well tolerated with a low incidence of adverse events, primarily gastrointestinal disorders, and has a favorable safety profile, making it an effective treatment option for EPI across various age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. Kuhn, RJ., Gelrud, A., Munck, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10854028/

Pancreatic enzyme replacement therapy in subjects with ... Of note, hypoglycemia symptoms improved in 4 out of the 5 subjects with pancreatogenic diabetes after PERT initiation (80%), versus in only 40% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05266963

Pancreatic Enzyme Replacement and Glucose Regulation ... Patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic ...

3. oncotarget.com oncotarget.com/article/21659/text/

Efficacy and safety of pancreatic enzyme replacement ... Conclusions: PERT is demonstrated to be effective and tolerable in patients with EPI, especially using standard administration of PERT. Larger ...

4. withpower.com withpower.com/trial/early-phase-1-diabetes-mellitus-type-1-4-2022-90e30

Pancreatic Enzyme Replacement Therapy for Type 1 ... Research shows that pancreatic enzyme replacement therapy, like CREON, helps improve nutrition and quality of life in conditions involving pancreatic issues, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10454644/

Survey of Pancreatic Enzyme Replacement Therapy Dosing ... Of these, 36.7% had been diagnosed with EPI for 3 or more years. A significant 72% felt they were not consistently consuming adequate enzymes, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5706924/

Efficacy and safety of pancreatic enzyme replacement ... PERT is demonstrated to be effective and tolerable in patients with EPI, especially using standard administration of PERT.