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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02308254




Registration number
NCT02308254
Ethics application status
Date submitted
3/11/2014
Date registered
4/12/2014
Date last updated
29/10/2015

Titles & IDs
Public title
Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People
Scientific title
Effects of Lixisenatide on Gastric Emptying, Glycaemia and 'Postprandial' Blood Pressure in Type 2 Diabetes and Healthy Subjects.
Secondary ID [1] 0 0
130419
Universal Trial Number (UTN)
Trial acronym
Lixi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 0 0
Gastroparesis 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

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

Active comparator: Lixisenatide - Lixisenatide: 10 mcg, one subcutaneous injection dose

Placebo comparator: Placebo - Matching placebo: one subcutaneous injection dose


Treatment: Drugs: Lixisenatide
Abdominal administration

Treatment: Drugs: Placebo
Abdominal administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood Pressure
Timepoint [1] 0 0
4.5 hours per study
Secondary outcome [1] 0 0
Heart rate
Timepoint [1] 0 0
4.5 hours per study
Secondary outcome [2] 0 0
Gastric emptying rate
Timepoint [2] 0 0
3 hours per study
Secondary outcome [3] 0 0
Blood glucose concentration
Timepoint [3] 0 0
3 hours per study

Eligibility
Key inclusion criteria
* Healthy subjects:

* Male or female (females using appropriate contraceptive method or willing to undergo pregnancy test)
* Body Mass Index (BMI) 19 - 30 kg/m2
* Type 2 Diabetic Patients:

* As per "healthy subjects"
* Type 2 diabetes (World Health Organisation (WHO) criteria) managed by diet alone or on metformin
* Glycated haemoglobin >6.0% and <8.5%
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Subjects with a history of severe respiratory, cardiovascular, hepatic and/or renal disease (severe in that the social or physical manifestations of the disease, or living with the condition, impact negatively and significantly on the individuals' ability to lead a normal day to day life), chronic alcohol abuse or epilepsy (excluded by history) or if iron status, or liver function tests are outside the following ranges:

1. Alanine aminotransferase (ALT) 0 - 55 U/L
2. Alkaline phosphatase 30 - 110 U/L
3. Aspartate transaminase 0 - 45 U/L
4. Amylase and/or lipase >3 x ULN
5. Bilirubin 6 - 24 mmol/L
6. Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
7. Haemoglobin 115 - 155 g/L (females); 135 - 172 g/L (males)
* Subjects with a creatinine clearance cut-off of <50 ml/min
* Subjects requiring medication likely to influence blood pressure or gastrointestinal function
* Subjects with a past history of gastrointestinal disease, including known gastroparesis, significant upper gastrointestinal symptoms and previous gastric surgery
* Subjects with a past history of unexplained pancreatitis, chronic pancreatitis, pancreatectomy
* Subjects with a current or prior history of c-cell carcinoma
* Smoking > 10 cigarettes/day
* Alchohol consumption > 20 g/day
* Subjects who have donated blood in the previous 12 weeks
* Women of childbearing potential with no effective contraceptive method (defined as premenopausal, not surgically sterile women for at least 3 months prior to the time of screening) must have a confirmed negative urine B-hCG pregnancy test at screening visit. They must also use an effective contraceptive method throughout the study, and agree to repeat urine pregnancy test at designated visits.
* Lactation

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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2016
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
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
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0

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, PhD
Address 0 0
University of Adelaide, Royal Adelaide Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rachael S Tippett, BSc Honours
Address 0 0
Country 0 0
Phone 0 0
8222 2915
Fax 0 0
Email 0 0
rachael.tippett@adelaide.edu.au
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/NCT02308254