Type 1 DiabetesEarly Phase 1CREONNCT05266963

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

A Early Phase 1 study testing CREON in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
What is being tested?: CREON
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 2 Sep 2022to 22 Mar 2024
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Currently receive care at the Eskind Diabetes Clinic at Vanderbilt University Medical Center
Diagnosed with T1DM for at least 12 months
Age over 18
Total daily dose of insulin greater than 0.7u/kg/day
Current use of a continuous glucose monitor
Current use of smart phone

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Able to read and speak English
Willingness and ability to download and provide CGM and pump (if applicable) data
Reduction of pancreas volume (<0.6mL/kg body weight)

Who cannot join

History of celiac disease or inflammatory bowel disease
Use of medication or supplements other than insulin to control blood glucose
Pregnancy or breast feeding
Following a restrictive diet (such as very low carb diet)

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37232

Other trials in United States

About this study

To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question.

The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).

Conditions: Type 1 Diabetes
Being tested: CREON, Placebo
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CREONDrug
The study will enroll 6-10 adult subjects with T1D who will receive both pancreatic enzyme replacement (CREON) or placebo each for 7 days in a random order. The effect of the intervention will be monitored by continuous glucose monitoring, diet recording, capsule counts, a mixed-meal tolerance test, and a survey to assess symptoms of PEI. This study design will allow for estimation of the effect of pancreatic enzyme replacement on the measured parameters.
PlaceboDrug
Placebo

Study groups in NCT05266963
Study group	Role	What they receive
CREON	Active comparator	CREON is a pancreatic enzyme replacement Receives: Drug: CREON
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in Glucose Regulation
Mixed meal tolerance testing (MMTT) will be used to assess glucose regulation via c-peptide AUC at baseline, and after treatment with placebo and CREON in a random order.
Measured: through study completion (4-5 weeks)
Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms
We will use the pancreatic exocrine insufficiency questionnaire (PEI-Q) to quantitate symptoms of PEI and their relative change from baseline to after treatment with placebo and Creon in a random order. Minimum score is 0, and maximum score is 4. Higher scores correlate to worse outcome, i.e., increased abdominal symptoms and bowel movement symptoms.
Measured: through study completion (4-5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 202222 Mar 2024

First posted4 Mar 2022
Study start2 Sep 2022
Primary completion22 Mar 2024
Study completion22 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will receive CREON and placebo in a random, blinded order.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05266963
Sponsor's protocol ID: 210734
Acronym: CREON
Status last verified: Mar 2025
First submitted: 14 Feb 2022
Last updated: 28 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No plans to share PHI.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
ClinicalTrials.gov ID: NCT05266963
Acronym / sponsor ID: CREON / 210734
Conditions: Type 1 Diabetes
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Vanderbilt University Medical CenterUniversity, hospital or other
Study start: 2 Sep 2022 (actual)
Primary completion: 22 Mar 2024 (actual)
Study completion: 22 Mar 2024 (actual)
First posted: 4 Mar 2022 (actual)
Results: Posted 28 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Participants will receive CREON and placebo in a random, blinded order.

Arm	Type	Receives
CREON	Active comparator	Drug: CREONCREON is a pancreatic enzyme replacement
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Currently receive care at the Eskind Diabetes Clinic at Vanderbilt University Medical Center
Diagnosed with T1DM for at least 12 months
Age over 18
Total daily dose of insulin greater than 0.7u/kg/day
Current use of a continuous glucose monitor

Key exclusion criteria (4 listed)

History of celiac disease or inflammatory bowel disease
Use of medication or supplements other than insulin to control blood glucose
Pregnancy or breast feeding
Following a restrictive diet (such as very low carb diet)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CREONThe study will enroll 6-10 adult subjects with T1D who will receive both pancreatic enzyme replacement (CREON) or placebo each for 7 days in a random order. The effect of the intervention will be monitored by continuous glucose monitoring, diet recording, capsule counts, a mixed-meal tolerance test, and a survey to assess symptoms of PEI. This study design will allow for estimation of the effect of pancreatic enzyme replacement on the measured parameters.	Drug	CREON
PlaceboPlacebo	Drug	Placebo

Primary outcome

Improvement in Glucose Regulation
Time frame: through study completion (4-5 weeks)
Mixed meal tolerance testing (MMTT) will be used to assess glucose regulation via c-peptide AUC at baseline, and after treatment with placebo and CREON in a random order.
Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms
Time frame: through study completion (4-5 weeks)
We will use the pancreatic exocrine insufficiency questionnaire (PEI-Q) to quantitate symptoms of PEI and their relative change from baseline to after treatment with placebo and Creon in a random order. Minimum score is 0, and maximum score is 4. Higher scores correlate to worse outcome, i.e., increased abdominal symptoms and bowel movement symptoms.

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CREON, Then Placebo	5	5
Placebo, Then CREON	6	5

Primary outcome: Improvement in Glucose Regulation

Time frame: through study completion (4-5 weeks). Mean (Full Range). Unit: ng*hr/mL

Measure	CREON n = 10	Placebo n = 10
Baseline	34.42 (17.1 to 128.8)	34.42 (17.1 to 128.8)
End of Drug Period	35.44 (19.14 to 125.7)	39.03 (15.95 to 160.48)

CREON vs Placebo: p = 0.43, Wilcoxon (Mann-Whitney)

Population analysed: This analysis population is the 10 participants who completed both drug periods of the study. Five received CREON, then placebo, and the other five received placebo, then CREON.

Primary outcome: Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms

Time frame: through study completion (4-5 weeks). Mean (Full Range). Unit: score on a scale

Measure	CREON n = 10	Placebo n = 10
Baseline	0.376 (0 to 0.833)	0.376 (0 to 0.833)
End of Drug Period	0.382 (0 to 0.893)	0.346 (0 to 0.81)

CREON vs Placebo: p = 0.52, t-test, 2 sided

Population analysed: This analysis population is the 10 participants who completed both drug periods of the study. Five participants received CREON, then placebo, and the other five received placebo, then CREON.

Adverse events

Time frame: Adverse events were collected through study completion, an average of 1 month per participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CREON	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Placebo	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): The intervention was given for a relatively short time, most patients had significantly reduced pancreas volume, and most had long histories of T1D. The baseline C-peptide levels in the subjects were very low. Assessment in individuals with new onset T1D, in younger subjects, or in individuals with greater residual beta cell function could produce different results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No plans to share PHI.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Moore, MD, PhD principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CREON in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Glucose Regulation (time frame: through study completion (4-5 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.