Pancreatic replacement therapy and glycaemic control in diabetes

Phase 1

Conditions: Type 1 diabetes and type 2 diabetes mellitusPancreatic exocrine insufficiency
MedDRA version: 20.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 20.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 20.0Level: LLTClassification code 10033628Term: Pancreatic insufficiencySystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2017-001227-45-GB

Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 18

Inclusion Criteria

The participant must meet ALL of the following criteria to be considered eligible for the study:
1. Male or Female, aged 18 years or above
2. Diagnosed with Type 1 diabetes or Type 2 diabetes at least 1 year ago and receiving oral and / or insulin therapy for diabetes
3. Have 1 or more symptoms of PEI:
- Diarrhoea – Bristol Stool Chart (see appendix) type 5, 6 or 7
- Steatorrhoea or greasy, pale or offensive smelling stools
- Weight loss
- Abdominal pain or cramps
- Bloating or increased flatulence
4. Low faecal elastase level <200mcg/g in last 2 years or since diabetes diagnosis, whichever is more recent
5. Willing and able to give informed consent for participation in the study and for GP to be informed

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:
1. Currently receiving, or have ever received, PERT
2. Current prescription of or planning to commence medication (within next 2 months), other than those for diabetes, that may increase or decrease serum glucose levels such as:
- Oral corticosteroids for more than 7 days
- Antipsychotics
- Nutritional supplements such as Fresubin®
- Weight-loss medication such as orlistat
3. Diagnosed with or suspected diagnosis of:
- Pancreatic malignancy
- Acute pancreatitis or chronic pancreatitis
- Type 3c diabetes or other secondary Type 3 diabetes
- Cystic fibrosis
- Previous or awaited gastric bypass (within next 2 months), pancreatic or extensive small bowel surgery
- Other primary pancreatic disorder or uncontrolled liver disorder (exception: non-alcoholic fatty liver disease)
4. Current or recently resolved (within 2 weeks) acute diarrhoeal episode thought likely to be infectious or other gastroenteritis
5. Current of previous chronic alcohol excess
6. Currently pregnant, recently postpartum (within 6 months) or planning pregnancy before end of study date
7. Currently using a modified diet under dietetic supervision, such as FODMAP
8. Currently receiving supported nutrition, including via nasogastric tube, gastrostomy tube or parenteral nutrition
9. Known allergy to Creon® or any of its components
10. Objection to porcine origin of pancreatin
11. Known allergy to Freestyle Libre Pro adhesive pad
12. Already enrolled in, or recently (within 6 weeks) taken part in, another study
- that may affect glycaemic control
- that may affect digestion or absorption or another aspect of the GI system

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare glucose variability in patients with diabetes and pancreatic exocrine insufficiency before starting pancreatic enzyme replacement therapy and 6 weeks after starting pancreatic enzyme replacement therapy.<br><br>;Secondary Objective: To compare other ambulatory glucose profile metrics prior to and 6 weeks after starting pancreatic enzyme replacement therapy:<br>- Glucose exposure<br>- Mean glucose<br>- Time in hyperglycaemia<br>- Time in target range<br>- Time in hypoglycaemia<br>- Glucose instability<br>- Estimated HbA1c<br>- To compare these during specific time periods including post-prandial (2-3 hours after meal)<br><br>To compare clinically important measures - HbA1c, weight and Body Mass Index;Primary end point(s): Mean interquartile range over 14 days at weeks 6-8 of pancreatic enzyme replacement rherapy as measured by the Freestyle Libre flash glucose monitor;Timepoint(s) of evaluation of this end point: At week 10, final study visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Other AGP metrics averaged over 14 days at weeks 6-8 of PERT therapy as measured by the Freestyle Libre flash glucose monitor:<br>- Area under the median curve (AUC)<br>- Median<br>- Time above target range (above 10mmol/L and above 15mmol/L)<br>- Time in target range (TIR) (4-10mmol/L)<br>- Time below target range (below 4mmol/L and below 3mmol/L)<br>- Median curve instability<br>- Specific time periods – including pre-prandial and post-prandial<br>- Estimated HbA1c<br><br>GI symptom questionnaire at 8 weeks after starting PERT<br>Clinical measurements – HbA1c, weight, BMI at 8 weeks after starting PERT;Timepoint(s) of evaluation of this end point: At week 10, final study visit

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