Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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.
Query!
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.
Query!
Secondary ID [1]
252285
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus
257807
0
Query!
Condition category
Condition code
Metabolic and Endocrine
257973
257973
0
0
Query!
Diabetes
Query!
Metabolic and Endocrine
257974
257974
0
0
Query!
Metabolic disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
256862
0
Treatment: Drugs
Query!
Comparator / control treatment
Enterically coated placebo pellets containing paracetamol but no lauric acid.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
258839
0
Blood glucose concentrations
Query!
Assessment method [1]
258839
0
Query!
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.
Query!
Secondary outcome [1]
264953
0
Insulin, glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and glucagon plasma concentrations
Query!
Assessment method [1]
264953
0
Query!
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.
Query!
Secondary outcome [2]
264954
0
Gastric emptying calculated from breath samples
Query!
Assessment method [2]
264954
0
Query!
Timepoint [2]
264954
0
Every 5 minutes for the first hour after lunch, then every 15 minutes for a further 3 hours
Query!
Secondary outcome [3]
264955
0
Sensations of appetite evaluated using a visual analogue questionnaire
Query!
Assessment method [3]
264955
0
Query!
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.
Query!
Secondary outcome [4]
264956
0
Plasma paracetamol concentrations
Query!
Assessment method [4]
264956
0
Query!
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
Query!
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%.
Query!
Minimum age
20
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random number table
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
2/08/2010
Query!
Actual
24/08/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
5/10/2011
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
10
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
257327
0
Commercial sector/Industry
Query!
Name [1]
257327
0
Meyer Nurticeuticals
Query!
Address [1]
257327
0
2210 La Mesa Drive
Santa Monica CA 90402
Query!
Country [1]
257327
0
United States of America
Query!
Primary sponsor type
Hospital
Query!
Name
Royal Adelaide Hospital
Query!
Address
North Terrace, Adelaide SA 5000
Query!
Country
Australia
Query!
Secondary sponsor category [1]
256570
0
None
Query!
Name [1]
256570
0
Query!
Address [1]
256570
0
Query!
Country [1]
256570
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
259351
0
Royal Adelaide Hospital Human Research Ethics Committee
Query!
Ethics committee address [1]
259351
0
Level 3, Hanson Institute Royal Adelaide
Hospital, North Terrace, Adelaide SA 5000
Query!
Ethics committee country [1]
259351
0
Australia
Query!
Date submitted for ethics approval [1]
259351
0
Query!
Approval date [1]
259351
0
28/06/2010
Query!
Ethics approval number [1]
259351
0
100520
Query!
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.
Query!
Trial website
Nil
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
31429
0
A/Prof Chris Rayner
Query!
Address
31429
0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Query!
Country
31429
0
Australia
Query!
Phone
31429
0
+61 8 82222916
Query!
Fax
31429
0
+61 8 82233870
Query!
Email
31429
0
[email protected]
Query!
Contact person for public queries
Name
14676
0
A/Prof A/Prof Chris Rayner
Query!
Address
14676
0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Query!
Country
14676
0
Australia
Query!
Phone
14676
0
+61 8 82222916
Query!
Fax
14676
0
+61 8 82233870
Query!
Email
14676
0
[email protected]
Query!
Contact person for scientific queries
Name
5604
0
A/Prof A/Prof Chris Rayner
Query!
Address
5604
0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Query!
Country
5604
0
Australia
Query!
Phone
5604
0
+61 8 82222916
Query!
Fax
5604
0
+61 8 82233870
Query!
Email
5604
0
[email protected]
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF