Clinical trial NCT02315495: Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
Official title: Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose concentrations at pre-defined intervals
timeFrame: -60,-10,0,30,60,90,120,180min
Secondary outcomes:
measure: Plasma concentrations of incretin hormones at pre-defined intervals
timeFrame: -60,-10,0,30,60,90,120,180min
measure: Plasma concentrations of insulin at pre-defined intervals
timeFrame: -60,-10,0,30,60,90,120,180min
measure: Plasma concentrations of C-peptide at pre-defined intervals
timeFrame: -60,-10,0,30,60,90,120,180min
measure: Plasma concentrations of glucagon at pre-defined intervals
timeFrame: -60,-10,0,30,60,90,120,180min
measure: half-emptying time (T50)
timeFrame: 0-180min
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University
state: Jiangsu
Study officials:
References: