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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

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
Type 2 Diabetes Drug: Saxagliptin Drug: Acarbose Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : April 3, 2015
Actual Primary Completion Date : August 26, 2016
Actual Study Completion Date : August 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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 Name: Onglyza

Drug: Acarbose
Other Name: Glucobay

Experimental: 5 mg saxagliptin

Acute dosing:

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

Drug: Saxagliptin
Other Name: Onglyza

Experimental: 100 mg acarbose

Acute dosing:

100 mg acarbose is given with a test meal

Drug: Acarbose
Other Name: Glucobay

No Intervention: control



Primary Outcome Measures :
  1. Blood glucose concentrations at pre-defined intervals [ Time Frame: -60,-10,0,30,60,90,120,180min ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315495


Locations
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China, Jiangsu
Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University
Nanjing, Jiangsu, China
Sponsors and Collaborators
Zilin Sun

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Responsible Party: Zilin Sun, MD, PhD of Department of Endocrinology, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT02315495     History of Changes
Other Study ID Numbers: ISSSAXA0015
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Acarbose
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Glycoside Hydrolase Inhibitors