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

NCT ID: NCT02315495

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-03
• Study Completion Date: 2016-08-26

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5 mg saxagliptin + 100 mg acarbose

Acute dosing:

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

Group Type: EXPERIMENTAL

Saxagliptin

Intervention Type: DRUG

Acarbose

Intervention Type: DRUG

5 mg saxagliptin

Acute dosing:

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

Group Type: EXPERIMENTAL

Saxagliptin

Intervention Type: DRUG

100 mg acarbose

Acute dosing:

100 mg acarbose is given with a test meal

Group Type: EXPERIMENTAL

Acarbose

Intervention Type: DRUG

control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Saxagliptin

Intervention Type: DRUG

Acarbose

Intervention Type: DRUG

Other Intervention Names

Onglyza; Glucobay

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zilin Sun

OTHER

Sponsor Role: lead

Responsible Party

Zilin Sun

MD, PhD of Department of Endocrinology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

ISSSAXA0015

Identifier Type: -

Identifier Source: org_study_id