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Trial registered on ANZCTR


Registration number
ACTRN12610000602022
Ethics application status
Approved
Date submitted
23/07/2010
Date registered
26/07/2010
Date last updated
25/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled study to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on the release of gastrointestinal peptides, glycaemic control, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with sitagliptin.
Scientific title
A randomised, double-blind, placebo-controlled study to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on the release of gastrointestinal peptides, glycaemic control, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with sitagliptin.
Secondary ID [1] 252285 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 257807 0
Condition category
Condition code
Metabolic and Endocrine 257973 257973 0 0
Diabetes
Metabolic and Endocrine 257974 257974 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each subject will undergo 2 study days, in double-blinded, randomised fashion, separated by 3 days. Three days prior to the first study day, subjects will cease their usual oral hypoglycaemic agent and commence sitagliptin oral tablet 100 mg each morning (ie. for three full days prior to the first study day). Subjects will remain on sitagliptin 100 mg daily until the second study day is completed, after which they will revert to their usual therapy (ie. they will receive a total of 7 days of sitagliptin). On each study day, subjects will take their daily dose of sitagliptin oral tablet 100 mg. 60 min later they will be given a test meal ("breakfast") containing 5g of either enterically coated pellets containing lauric acid ("CTM#3") and paracetamol (as a maker of lauric acid release) or placebo pellets. A second identical test meal (“lunch”) will be consumed 4 hours after breakfast, and will again contain 5g of either CTM#3 or placebo pellets , and also 100 mg 13C-octanoic acid, as a marker of gastric emptying. Those who receive CTM#3 at breakfast will also receive it at lunch, and the same for placebo.
Intervention code [1] 256862 0
Treatment: Drugs
Comparator / control treatment
Enterically coated placebo pellets containing paracetamol but no lauric acid.
Control group
Placebo

Outcomes
Primary outcome [1] 258839 0
Blood glucose concentrations
Timepoint [1] 258839 0
0, 15, 30, 60, 90, 120, 150, 180, 240, 255, 270, 300, 330, 360, 390, 420, and 480 minutes after breakfast.
Secondary outcome [1] 264953 0
Insulin, glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and glucagon plasma concentrations
Timepoint [1] 264953 0
0, 15, 30, 60, 90, 120, 150, 180, 240, 255, 270, 300, 330, 360, 390, 420, and 480 minutes after breakfast.
Secondary outcome [2] 264954 0
Gastric emptying calculated from breath samples
Timepoint [2] 264954 0
Every 5 minutes for the first hour after lunch, then every 15 minutes for a further 3 hours
Secondary outcome [3] 264955 0
Sensations of appetite evaluated using a visual analogue questionnaire
Timepoint [3] 264955 0
2 minutes before breakfast, and 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 255, 270, 285, 300, 330, 360, 390, 420, 450 and 480 minutes after breakfast.
Secondary outcome [4] 264956 0
Plasma paracetamol concentrations
Timepoint [4] 264956 0
0, 15, 30, 60, 90, 120, 150, 180, 240, 255, 270, 300, 330, 360, 390, 420, and 480 minutes after breakfast

Eligibility
Key inclusion criteria
Type 2 diabetes, treated by diet alone or single oral hypoglycaemic agent; Body mass index (BMI) 25 - 35 kg/m2; glycated haemoglobin (HbA1c) 7.5% - 9.0%.
Minimum age
20 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Requirement for insulin therapy; Use of any medication that may influence gastrointestinal function within 48 hours of the study; Intake of >20 g alcohol on a daily basis, or cigarette smoking; History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy); Unstable cardiac disease, other serious illness or a cardiovascular or cerebrovascular event within the last 3 months; Postural hypotension (defined by a standing systolic blood pressure < 110mmHg or standing diastolic blood pressure < 60mmHg); Impaired renal or liver function (as assessed by calculated creatinine clearance < 90 mL/min or abnormal liver function tests (>2 times upper limit of normal)); Allergy to paracetamol or sitagliptin; Donation of blood within the previous 3 months; Inability to monitor blood glucose at home with a glucometer; Pregnancy or lactation (the former verified by urine testing in women of reproductive age; in women who are not pregnant or lactating, the study will be completed during the follicular phase of the menstrual cycle); Haemoglobin below lower limit of normal (135 g/L for mean, 115 g/L for women), or ferritin below lower limit of normal (10 mcg/L).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257327 0
Commercial sector/Industry
Name [1] 257327 0
Meyer Nurticeuticals
Address [1] 257327 0
2210 La Mesa Drive
Santa Monica CA 90402
Country [1] 257327 0
United States of America
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 256570 0
None
Name [1] 256570 0
Address [1] 256570 0
Country [1] 256570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259351 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 259351 0
Level 3, Hanson Institute Royal Adelaide
Hospital, North Terrace, Adelaide SA 5000
Ethics committee country [1] 259351 0
Australia
Date submitted for ethics approval [1] 259351 0
Approval date [1] 259351 0
28/06/2010
Ethics approval number [1] 259351 0
100520

Summary
Brief summary
The purpose of the study is to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on glycaemic control, the release of gastrointestinal peptides, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with the dipeptidyl dipeptidase IV inhibitor, sitagliptin.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31429 0
A/Prof Chris Rayner
Address 31429 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 31429 0
Australia
Phone 31429 0
+61 8 82222916
Fax 31429 0
+61 8 82233870
Email 31429 0
chris.rayner@adelaide.edu.au
Contact person for public queries
Name 14676 0
A/Prof A/Prof Chris Rayner
Address 14676 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 14676 0
Australia
Phone 14676 0
+61 8 82222916
Fax 14676 0
+61 8 82233870
Email 14676 0
chris.rayner@adelaide.edu.au
Contact person for scientific queries
Name 5604 0
A/Prof A/Prof Chris Rayner
Address 5604 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 5604 0
Australia
Phone 5604 0
+61 8 82222916
Fax 5604 0
+61 8 82233870
Email 5604 0
chris.rayner@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary