Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02324010




Registration number
NCT02324010
Ethics application status
Date submitted
16/12/2014
Date registered
24/12/2014
Date last updated
7/07/2017

Titles & IDs
Public title
Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes
Scientific title
Effects of Sitagliptin on Postprandial Glycaemia, Incretin Hormones and Blood Pressure in Type 2 Diabetes - Relationship to Gastric Emptying
Secondary ID [1] 0 0
140916
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Diabetes Mellitus 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sitagliptin
Treatment: Drugs - Placebo

Experimental: Sitaglipltin (100mg) - Active drug (sitagliptin)

Placebo comparator: Placebo (sugar pill) - Inactive drug (placebo)


Treatment: Drugs: Sitagliptin
100mg mane for 2 days

Treatment: Drugs: Placebo
Inactive drug (Placebo)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Gastric emptying
Timepoint [1] 0 0
3 hours per gastric emptying study (i.e. 6 hours)
Secondary outcome [1] 0 0
Glycaemia
Timepoint [1] 0 0
4 hours during each gastric empty study (i.e. 8 hours)
Secondary outcome [2] 0 0
Gastrointestinal hormone release
Timepoint [2] 0 0
4 hours during each gastric empty study (i.e. 8 hours)
Secondary outcome [3] 0 0
Intragastric meal distribution
Timepoint [3] 0 0
3 hours during each gastric empty study (i.e. 6 hours)
Secondary outcome [4] 0 0
Blood pressure
Timepoint [4] 0 0
4.5 hours during each gastric empty study (i.e. 9 hours)
Secondary outcome [5] 0 0
Heart rate
Timepoint [5] 0 0
4.5 hours during each gastric empty study (i.e. 9 hours)
Secondary outcome [6] 0 0
Splanchnic blood flow
Timepoint [6] 0 0
4 hours during each gastric empty study (i.e. 8 hours)
Secondary outcome [7] 0 0
Cardiac output
Timepoint [7] 0 0
4 hours during each gastric empty study (i.e. 8 hours)
Secondary outcome [8] 0 0
Stroke volume
Timepoint [8] 0 0
4 hours during each gastric empty study (i.e. 8 hours)
Secondary outcome [9] 0 0
Appetite
Timepoint [9] 0 0
4 hours during each gastric empty study (i.e. 8 hours)

Eligibility
Key inclusion criteria
* Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet or metformin alone
* Body mass index (BMI) 20 - 40 kg/m2
* Males and females (females of reproductive potential must be using an appropriate contraceptive method)
* Glycated haemoglobin (HbA1c) = 8.5%
* Haemoglobin above the lower limit of the normal range (i.e. >135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (i.e. >10mcg/L)
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with gastrointestinal disease, significant upper or lower gastrointestinal symptoms, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
* Other significant illness, including epilepsy, cardiovascular or respiratory disease.
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
* Impaired renal or liver function (as assessed by calculated creatinine clearance < 50 mL/min using the Cockroft-Gault equation (27) or abnormal liver function tests (> 2 times upper limit of normal range)).
* Requirement for medication known to influence blood pressure and/or heart rate and/or gastrointestinal function, drugs with anticholinergic effects
* Alcohol consumption > 20 g per day
* Smoking > 10 cigarettes per day
* Pregnancy or lactation.
* Vegetarian
* Allergy to sitagliptin or any other 'gliptin'.
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Exposure to ionising radiation for research purposes in the previous 12 months
* Inability to give informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide, Discipline of Medicine, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Adelaide Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karen L Jones, DAppSci, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02324010