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

Zilin Sun

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Saxagliptin; Drug: Acarbose

Study type: Interventional

Funder types: Other

Identifiers

NCT02315495

ISSSAXA0015

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 4 patient groups

5 mg saxagliptin + 100 mg acarbose

Experimental group

Description:

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

Treatment:

Drug: Acarbose

Drug: Saxagliptin

5 mg saxagliptin

Experimental group

Description:

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

Treatment:

Drug: Saxagliptin

100 mg acarbose

Experimental group

Description:

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

Treatment:

Drug: Acarbose

control

No Intervention group