Trial Outcomes & Findings for Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes (NCT NCT05266963)
NCT ID: NCT05266963
Last Updated: 2025-03-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
11 participants
Primary outcome timeframe
through study completion (4-5 weeks)
Results posted on
2025-03-28
Participant Flow
Participants were enrolled at Vanderbilt University Medical Center from September 2022 through March 2024. Subjects were eligible based on reduced pancreas volume as determined through their prior participation in MAP-T1D (IRB 130833).
Eleven (11) participants were enrolled to achieve completion goal of ten (10). One subject withdrew at end of drug period A due to failed OGTT and unwillingness to continue.
Participant milestones
| Measure |
CREON, Then Placebo
CREON is a pancreatic enzyme replacement
CREON: 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.
|
Placebo, Then CREON
CREON is a pancreatic enzyme replacement
CREON: 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.
|
|---|---|---|
|
Drug Period A
STARTED
|
5
|
6
|
|
Drug Period A
COMPLETED
|
5
|
5
|
|
Drug Period A
NOT COMPLETED
|
0
|
1
|
|
Washout
STARTED
|
5
|
5
|
|
Washout
COMPLETED
|
5
|
5
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Drug Period B (Crossover)
STARTED
|
5
|
5
|
|
Drug Period B (Crossover)
COMPLETED
|
5
|
5
|
|
Drug Period B (Crossover)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
CREON, Then Placebo
CREON is a pancreatic enzyme replacement
CREON: 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.
|
Placebo, Then CREON
CREON is a pancreatic enzyme replacement
CREON: 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.
|
|---|---|---|
|
Drug Period A
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
CREON, Then Placebo
n=5 Participants
CREON is a pancreatic enzyme replacement
CREON: 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.
|
Placebo, Then CREON
n=5 Participants
CREON is a pancreatic enzyme replacement
CREON: 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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.2 years
n=5 Participants
|
22.3 years
n=7 Participants
|
33.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Weight
|
69.7 kg
n=5 Participants
|
84.8 kg
n=7 Participants
|
77.3 kg
n=5 Participants
|
|
Pancreatic exocrine insufficiency score
|
0.44 units on a scale
n=5 Participants
|
0.312 units on a scale
n=7 Participants
|
0.376 units on a scale
n=5 Participants
|
|
C-peptide AUC
|
44.4 ng*hr/mL
n=5 Participants
|
24.9 ng*hr/mL
n=7 Participants
|
34.4 ng*hr/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: through study completion (4-5 weeks)Population: 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.
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.
Outcome measures
| Measure |
CREON
n=10 Participants
CREON is a pancreatic enzyme replacement
CREON: 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.
|
Placebo
n=10 Participants
CREON is a pancreatic enzyme replacement
CREON: 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.
|
|---|---|---|
|
Improvement in Glucose Regulation
Baseline
|
34.42 ng*hr/mL
Interval 17.1 to 128.8
|
34.42 ng*hr/mL
Interval 17.1 to 128.8
|
|
Improvement in Glucose Regulation
End of Drug Period
|
35.44 ng*hr/mL
Interval 19.14 to 125.7
|
39.03 ng*hr/mL
Interval 15.95 to 160.48
|
PRIMARY outcome
Timeframe: through study completion (4-5 weeks)Population: 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.
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.
Outcome measures
| Measure |
CREON
n=10 Participants
CREON is a pancreatic enzyme replacement
CREON: 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.
|
Placebo
n=10 Participants
CREON is a pancreatic enzyme replacement
CREON: 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.
|
|---|---|---|
|
Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms
Baseline
|
0.376 score on a scale
Interval 0.0 to 0.833
|
0.376 score on a scale
Interval 0.0 to 0.833
|
|
Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms
End of Drug Period
|
0.382 score on a scale
Interval 0.0 to 0.893
|
0.346 score on a scale
Interval 0.0 to 0.81
|
Adverse Events
CREON
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dan Moore, M.D., Ph.D.
Vanderbilt University Medical Center
Phone: 615-322-7247
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place