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Pancreatic Enzyme Replacement

Pancreatic Enzyme Replacement Therapy for Type 1 Diabetes (CREON Trial)

Phase < 1
Waitlist Available
Led By Daniel Moore, MD, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Total daily dose of insulin greater than 0.7u/kg/day
Reduction of pancreas volume (<0.6mL/kg body weight)
Must not have
History of celiac disease or inflammatory bowel disease
Use of medication or supplements other than insulin to control blood glucose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (4-5 weeks)
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, pancreatic enzyme replacements like CREON may cause digestive issues such as stomach pain, gas, bloating; allergic reactions; and changes in blood sugars.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I use more than 0.7 units of insulin per kilogram of my body weight daily.
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My pancreas is smaller than usual for my body weight.
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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of celiac disease or inflammatory bowel disease.
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I use medication or supplements, not including insulin, to manage my blood sugar.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (4-5 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (4-5 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in glucose regulation
Patient-reported change in pancreatic exocrine insufficiency (PEI) symptoms

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CREONActive Control1 Intervention
CREON is a pancreatic enzyme replacement
Group II: PlaceboPlacebo Group1 Intervention
Placebo

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for Type 1 Diabetes (T1D) is insulin therapy, which replaces the insulin that the pancreas is unable to produce, thereby regulating blood glucose levels and preventing complications. Additionally, Pancreatic Enzyme Replacement Therapy (PERT), such as CREON, is being studied for its potential to improve glycemic control and reduce symptoms of pancreatic exocrine insufficiency by supplementing digestive enzymes. This is particularly important for T1D patients with reduced pancreatic volume and exocrine function, as it can enhance nutrient absorption and stabilize blood glucose levels.
Progress in the development of immune-based therapies for type 1 diabetes mellitus.[Conservative treatment of chronic pancreatitis].Interactions between the endocrine and exocrine pancreas and their clinical relevance.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
892 Previous Clinical Trials
936,511 Total Patients Enrolled
Daniel Moore, MD, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

CREON (Pancreatic Enzyme Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05266963 — Phase < 1
Type 1 Diabetes Research Study Groups: Placebo, CREON
Type 1 Diabetes Clinical Trial 2023: CREON Highlights & Side Effects. Trial Name: NCT05266963 — Phase < 1
CREON (Pancreatic Enzyme Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05266963 — Phase < 1
~3 spots leftby Oct 2025