Type 2 Diabetes
Conditions
Brief summary
The proposed study is designed to evaluate (i) the effects of saxagliptin, with or without acarbose, on gastric emptying, postprandial glycaemia, and plasma intact GLP-1, insulin, C-peptide and glucagon after a high carbohydrate meal, and (ii) whether the magnitude of the effects of saxagliptin and/or acarbose is related to the rate of gastric emptying, in patients with type 2 diabetes.
Interventions
DRUGSaxagliptin
DRUGAcarbose
Sponsors
Zilin Sun
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet alone (i.e. no oral hypoglycaemic drugs or insulin) * Body mass index (BMI) 20 - 40 kg/m2 * Age 18 - 70 years * Males and post-menopausal females (to control for the effect of the menstrual cycle on gut hormone secretion) * Glycated haemoglobin A1c (HbA1c) ≥ 6.0% and ≤ 7.9% * 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
* Use of any medication that may influence gastrointestinal motor function, body weight or appetite * Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis * History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy) * Other significant illness, including epilepsy, cardiovascular or respiratory disease * Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests \[36\]) * Impaired renal or liver function (as assessed by calculated creatinine clearance \< 90 mL/min or abnormal liver function tests (\> 2 times upper limit of normal range)) * Allergy to vildagliptin or any other 'gliptin' * Donation of blood within the previous 3 months * Participation in any other research studies within the previous 3 months * Females who are pre-menopausal * Inability to give informed consent * Vegetarians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood glucose concentrations at pre-defined intervals | -60,-10,0,30,60,90,120,180min |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of incretin hormones at pre-defined intervals | -60,-10,0,30,60,90,120,180min |
| Plasma concentrations of insulin at pre-defined intervals | -60,-10,0,30,60,90,120,180min |
| Plasma concentrations of C-peptide at pre-defined intervals | -60,-10,0,30,60,90,120,180min |
| Plasma concentrations of glucagon at pre-defined intervals | -60,-10,0,30,60,90,120,180min |
| half-emptying time (T50) | 0-180min |
Countries
China
Outcome results
None listed