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

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ClinicalTrials.gov Identifier: NCT02315495
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Zilin Sun, Zhongda Hospital

Tracking Information
First Submitted Date  ICMJE December 3, 2014
First Posted Date  ICMJE December 12, 2014
Last Update Posted Date July 6, 2018
Study Start Date  ICMJE April 3, 2015
Actual Primary Completion Date August 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
Blood glucose concentrations at pre-defined intervals [ Time Frame: -60,-10,0,30,60,90,120,180min ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02315495 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
  • Plasma concentrations of incretin hormones at pre-defined intervals [ Time Frame: -60,-10,0,30,60,90,120,180min ]
  • Plasma concentrations of insulin at pre-defined intervals [ Time Frame: -60,-10,0,30,60,90,120,180min ]
  • Plasma concentrations of C-peptide at pre-defined intervals [ Time Frame: -60,-10,0,30,60,90,120,180min ]
  • Plasma concentrations of glucagon at pre-defined intervals [ Time Frame: -60,-10,0,30,60,90,120,180min ]
  • half-emptying time (T50) [ Time Frame: 0-180min ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
Official Title  ICMJE Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Saxagliptin
    Other Name: Onglyza
  • Drug: Acarbose
    Other Name: Glucobay
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Saxagliptin
    • Drug: Acarbose
  • Experimental: 5 mg saxagliptin

    Acute dosing:

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

    Intervention: Drug: Saxagliptin
  • Experimental: 100 mg acarbose

    Acute dosing:

    100 mg acarbose is given with a test meal

    Intervention: Drug: Acarbose
  • No Intervention: control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2014)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 26, 2016
Actual Primary Completion Date August 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315495
Other Study ID Numbers  ICMJE ISSSAXA0015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zilin Sun, Zhongda Hospital
Study Sponsor  ICMJE Zilin Sun
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zhongda Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP