Trial | NCT02315495  Report issue

Official Title

Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    22
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.
Study Started
Apr 03
2015
Primary Completion
Aug 26
2016
Study Completion
Aug 26
2016
Last Update
Jul 06
2018

Drug Saxagliptin

  • Other names: Onglyza

Drug Acarbose

  • Other names: Glucobay

5 mg saxagliptin + 100 mg acarbose Experimental

Acute dosing: 5 mg saxagliptin is given with water, 60 min before a test meal 100 mg acarbose is given with a test meal

5 mg saxagliptin Experimental

Acute dosing: 5 mg saxagliptin is given 60 min before a test meal,

100 mg acarbose Experimental

Acute dosing: 100 mg acarbose is given with a test meal

control No Intervention

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
No Results Posted