Effects of Sitagliptin on Gastric Emptying, Glycaemia and Blood Pressure in Type 2 Diabetes

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the acute effects of sitagliptin on postprandial glycemia, incretin hormones and blood pressure, and the relationship to gastric emptying, after a mashed potato meal in patients with type 2 diabetes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Adelaide Hospital
• Treatments: Gastric Inhibitory Polypeptide; Incretins; Sitagliptin Phosphate

Criteria

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)

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