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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Saxagliptin; Drug: Acarbose

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control
EXPERIMENTAL: 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	Drug: Saxagliptin; Other Names: Onglyza; Drug: Acarbose; Other Names: Glucobay
EXPERIMENTAL: 5 mg saxagliptin; Acute dosing: 5 mg saxagliptin is given 60 min before a test meal,	Drug: Saxagliptin; Other Names: Onglyza
EXPERIMENTAL: 100 mg acarbose; Acute dosing: 100 mg acarbose is given with a test meal	Drug: Acarbose; Other Names: Glucobay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Blood glucose concentrations at pre-defined intervals	-60,-10,0,30,60,90,120,180min

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of incretin hormones at pre-defined intervals	-60,-10,0,30,60,90,120,180min
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 glucagon at pre-defined intervals	-60,-10,0,30,60,90,120,180min
half-emptying time (T50)	0-180min

Collaborators and Investigators

• Sponsor: Zilin Sun

Study record dates

Study Major Dates

• Study Start: April 3, 2015
• Primary Completion (ACTUAL): August 26, 2016
• Study Completion (ACTUAL): August 26, 2016

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (ESTIMATE): December 12, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose; Saxagliptin
• Other Study ID Numbers: ISSSAXA0015