Drug Trial of Lixisenatide on Gastric Emptying and Blood Pressure Drops in Type 2 Diabetics and Healthy People

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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 after a glucose drink in both healthy subjects and people with type 2 diabetes. If lixisenatide is shown to be effective, it would encourage ongoing evaluation of its potential use in the management of the falls in blood pressure following a meal in diabetic patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Royal Adelaide Hospital
• Collaborators: National Health and Medical Research Council, Australia; Sanofi
• Treatments: Lixisenatide

Criteria

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%

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