Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
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
[email protected]
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