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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315495
• Other study ID #: ISSSAXA0015
• Status: Completed
• Phase: Phase 3
• Start date: April 3, 2015
• Est. completion date: August 26, 2016

Study information

• Verified date: July 2018
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 26, 2016
• Est. primary completion date: August 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin

• Acarbose

Locations

Country	Name	City	State
China	Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zilin Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose concentrations at pre-defined intervals		-60,-10,0,30,60,90,120,180min
Secondary	Plasma concentrations of incretin hormones at pre-defined intervals		-60,-10,0,30,60,90,120,180min
Secondary	Plasma concentrations of insulin at pre-defined intervals		-60,-10,0,30,60,90,120,180min
Secondary	Plasma concentrations of C-peptide at pre-defined intervals		-60,-10,0,30,60,90,120,180min
Secondary	Plasma concentrations of glucagon at pre-defined intervals		-60,-10,0,30,60,90,120,180min
Secondary	half-emptying time (T50)		0-180min