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

11 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a medication that replaces missing digestive enzymes in people with Type 1 Diabetes who have a smaller pancreas. The goal is to help these patients better control their blood sugar and improve digestion.

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 CREON safe for humans?

CREON, a pancreatic enzyme replacement therapy, has been shown to be safe in humans, with common side effects being mild stomach issues and skin reactions. It has been used safely for many years in patients with conditions like cystic fibrosis and chronic pancreatitis, and studies show it is generally well tolerated with few people stopping treatment due to side effects. ^{1 2 3 4 5}

How does the drug CREON differ from other treatments for Type 1 Diabetes?

CREON is unique because it is a pancreatic enzyme replacement therapy typically used for conditions like exocrine pancreatic insufficiency, not Type 1 Diabetes. It works by providing enzymes to help digest food, which is different from standard diabetes treatments that focus on insulin regulation. ^{1 2 3 6 7}

What data supports the effectiveness of the drug CREON for Type 1 Diabetes?

Research shows that pancreatic enzyme replacement therapy, like CREON, helps improve nutrition and quality of life in conditions involving pancreatic issues, such as tropical calculous pancreatitis and exocrine pancreatic insufficiency. While direct evidence for Type 1 Diabetes is limited, these findings suggest potential benefits in managing related digestive problems. ^{2 8 9 10 11}

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

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]

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]

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]

Citations

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

Oral pancreatic enzyme therapy in the control of diabetes mellitus in tropical calculous pancreatitis. [2023]

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

Glycemic Variability Assessment in Newly Treated Exocrine Pancreatic Insufficiency With Type 1 Diabetes. [2022]

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

Pain reduction by an oral pancreatic enzyme preparation in chronic pancreatitis. [2019]

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

Efficacy and Safety of Pancrelipase/Pancreatin in Patients With Exocrine Pancreatic Insufficiency and a Medical History of Diabetes Mellitus. [2017]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. [2022]

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

CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Efficacy of a new microencapsulated pancreatin versus a conventional preparation, in the treatment of steatorrhea of pancreatic origin]. [2009]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Experience with the use of 13C-breath test for the evaluation of the efficacy of enzyme substitution therapy with microencapsulated pancreatinin in patients with severe primary pancreatic insufficiency]. [2015]

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

In Vitro Comparison of Physical Parameters, Enzyme Activity, Acid Resistance, and pH Dissolution Characteristics of Enteric-Coated Pancreatic Enzyme Preparations: Implications for Clinical Variability and Pharmacy Substitution. [2021]

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

The effects of oral pancreatic enzymes (Creon 10 capsule) on steatorrhea: a multicenter, placebo-controlled, parallel group trial in subjects with chronic pancreatitis. [2022]

11. United States 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. [2022]