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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Acarbose; Drug: Saxagliptin

• Registration Number: NCT02315495
• Lead Sponsor: Zilin Sun

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-03
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-12
• Study Start: 2015-04-03
• Primary Completion: 2016-08-26
• Study Completion: 2016-08-26
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
100 mg acarbose	Acarbose	Acute dosing: 100 mg acarbose is given with a test meal
5 mg saxagliptin + 100 mg acarbose	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
5 mg saxagliptin + 100 mg acarbose	Saxagliptin	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	Saxagliptin	Acute dosing: 5 mg saxagliptin is given 60 min before a test meal,

Primary Outcome Measures

Name	Time	Method
Blood glucose concentrations at pre-defined intervals	-60,-10,0,30,60,90,120,180min

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of insulin at pre-defined intervals	-60,-10,0,30,60,90,120,180min
Plasma concentrations of C-peptide at pre-defined intervals	-60,-10,0,30,60,90,120,180min
Plasma concentrations of incretin hormones at pre-defined intervals	-60,-10,0,30,60,90,120,180min
Plasma concentrations of glucagon at pre-defined intervals	-60,-10,0,30,60,90,120,180min
half-emptying time (T50)	0-180min

Trial Locations

Locations (1)

Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University; 🇨🇳 Nanjing, Jiangsu, China