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

Sponsor
Zilin Sun (Other)
Overall Status
Completed
CT.gov ID
NCT02315495
Collaborator
(none)
22
Enrollment
1
Location
4
Arms
16.8
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
Study Start Date :
Apr 3, 2015
Actual Primary Completion Date :
Aug 26, 2016
Actual Study Completion Date :
Aug 26, 2016

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    No Intervention: control

    Outcome Measures

    Primary Outcome Measures

    1. Blood glucose concentrations at pre-defined intervals [-60,-10,0,30,60,90,120,180min]

    Secondary Outcome Measures

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

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

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

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

    5. half-emptying time (T50) [0-180min]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University Nanjing Jiangsu China

    Sponsors and Collaborators

    • Zilin Sun

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zilin Sun, MD, PhD of Department of Endocrinology, Zhongda Hospital
    ClinicalTrials.gov Identifier:
    NCT02315495
    Other Study ID Numbers:
    • ISSSAXA0015
    First Posted:
    Dec 12, 2014
    Last Update Posted:
    Jul 6, 2018
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Saxagliptin
    Acarbose

    Study Results

    No Results Posted as of Jul 6, 2018