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Completed

NCT Number: NCT02315495

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Nanjing, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saxagliptin

Drug

Other names: Onglyza

Acarbose

Drug

Other names: Glucobay

Primary outcomes

  1. Blood glucose concentrations at pre-defined intervals

    Time frame: -60,-10,0,30,60,90,120,180min

Secondary outcomes

  1. Plasma concentrations of incretin hormones at pre-defined intervals

    Time frame: -60,-10,0,30,60,90,120,180min

  2. Plasma concentrations of insulin at pre-defined intervals

    Time frame: -60,-10,0,30,60,90,120,180min

  3. Plasma concentrations of C-peptide at pre-defined intervals

    Time frame: -60,-10,0,30,60,90,120,180min

  4. Plasma concentrations of glucagon at pre-defined intervals

    Time frame: -60,-10,0,30,60,90,120,180min

  5. half-emptying time (T50)

    Time frame: 0-180min

Sponsors and collaborators

Lead sponsor

Zilin Sun

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 12, 2014
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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