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

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Saxagliptin

Acarbose

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

5 mg saxagliptin + 100 mg acarbose

5 mg saxagliptin

100 mg acarbose

control

Arm Description

Acute dosing: 5 mg saxagliptin is given with water, 60 min before a test meal 100 mg acarbose is given with a test meal

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

Acute dosing: 100 mg acarbose is given with a test meal

Outcomes

Primary Outcome Measures

Blood glucose concentrations at pre-defined intervals

Secondary Outcome Measures

Plasma concentrations of incretin hormones at pre-defined intervals

Plasma concentrations of insulin at pre-defined intervals

Plasma concentrations of C-peptide at pre-defined intervals

Plasma concentrations of glucagon at pre-defined intervals

half-emptying time (T50)

Full Information

NCT ID

NCT02315495

First Posted

December 3, 2014

Last Updated

July 4, 2018

Sponsor

Zilin Sun

1. Study Identification

Unique Protocol Identification Number

NCT02315495

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

April 3, 2015 (undefined)

Primary Completion Date

August 26, 2016 (Actual)

Study Completion Date

August 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zilin Sun

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5 mg saxagliptin + 100 mg acarbose

Arm Type

Experimental

Arm Description

Acute dosing: 5 mg saxagliptin is given with water, 60 min before a test meal 100 mg acarbose is given with a test meal

Arm Title

5 mg saxagliptin

Arm Type

Experimental

Arm Description

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

Arm Title

100 mg acarbose

Arm Type

Experimental

Arm Description

Acute dosing: 100 mg acarbose is given with a test meal

Arm Title

control

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

Saxagliptin

Other Intervention Name(s)

Onglyza

Intervention Type

Drug

Intervention Name(s)

Acarbose

Other Intervention Name(s)

Glucobay

Primary Outcome Measure Information:

Title

Blood glucose concentrations at pre-defined intervals

Time Frame

-60,-10,0,30,60,90,120,180min

Secondary Outcome Measure Information:

Title

Plasma concentrations of incretin hormones at pre-defined intervals

Time Frame

-60,-10,0,30,60,90,120,180min

Title

Plasma concentrations of insulin at pre-defined intervals

Time Frame

-60,-10,0,30,60,90,120,180min

Title

Plasma concentrations of C-peptide at pre-defined intervals

Time Frame

-60,-10,0,30,60,90,120,180min

Title

Plasma concentrations of glucagon at pre-defined intervals

Time Frame

-60,-10,0,30,60,90,120,180min

Title

half-emptying time (T50)

Time Frame

0-180min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

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

City

Nanjing

State/Province

Jiangsu

Country

China

12. IPD Sharing Statement

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

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