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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02315495
• Date of registration: 03/12/2014
• Prospective Registration: Yes
• Primary sponsor: Zilin Sun
• Public title: Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
• Scientific title: Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
• Date of first enrolment: April 3, 2015
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02315495
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

China

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Acarbose

Drug: Saxagliptin

Primary Outcome(s)

Blood glucose concentrations at pre-defined intervals [Time Frame: -60,-10,0,30,60,90,120,180min]

Secondary Outcome(s)

Plasma concentrations of glucagon at pre-defined intervals [Time Frame: -60,-10,0,30,60,90,120,180min]

Plasma concentrations of insulin at pre-defined intervals [Time Frame: -60,-10,0,30,60,90,120,180min]

Plasma concentrations of C-peptide at pre-defined intervals [Time Frame: -60,-10,0,30,60,90,120,180min]

Plasma concentrations of incretin hormones at pre-defined intervals [Time Frame: -60,-10,0,30,60,90,120,180min]

half-emptying time (T50) [Time Frame: 0-180min]

Secondary ID(s)

ISSSAXA0015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors