Status:
UNKNOWN
Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People
Lead Sponsor:
Royal Adelaide Hospital
Collaborating Sponsors:
Sanofi
National Health and Medical Research Council, Australia
Conditions:
Diabetes Mellitus
Gastroparesis
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the effects of the drug lixisenatide on blood sugar levels, stomach emptying, blood pressure and heart rate, release of gut hormones and blood flow in the gut...
Detailed Description
Lixisenatide is a drug that has been shown to reduce postprandial glycaemia in people with type 2 diabetes and is now approved for use in Australia. Although slowing of gastric emptying is likely to b...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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:
- Alanine aminotransferase (ALT) 0 - 55 U/L
- Alkaline phosphatase 30 - 110 U/L
- Aspartate transaminase 0 - 45 U/L
- Amylase and/or lipase \>3 x ULN
- Bilirubin 6 - 24 mmol/L
- Ferritin 15 - 200 ng/mL (females); 30 - 300 ng/mL (males)
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02308254
Start Date
November 1 2013
End Date
April 1 2016
Last Update
October 29 2015
Active Locations (1)
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1
Discipline of Medicine, Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000