NCT02315495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

April 3, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2016

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

December 3, 2014

Last Update Submit

July 4, 2018

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Blood glucose concentrations at pre-defined intervals

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

Secondary Outcomes (5)

  • Plasma concentrations of incretin hormones at pre-defined intervals

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

  • Plasma concentrations of insulin at pre-defined intervals

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

  • Plasma concentrations of C-peptide at pre-defined intervals

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

  • Plasma concentrations of glucagon at pre-defined intervals

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

  • half-emptying time (T50)

    0-180min

Study Arms (4)

5 mg saxagliptin + 100 mg acarbose

EXPERIMENTAL

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: SaxagliptinDrug: Acarbose

5 mg saxagliptin

EXPERIMENTAL

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

Drug: Saxagliptin

100 mg acarbose

EXPERIMENTAL

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

Drug: Acarbose

control

NO INTERVENTION

Interventions

SaxagliptinDRUG
Also known as: Onglyza
5 mg saxagliptin5 mg saxagliptin + 100 mg acarbose
AcarboseDRUG
Also known as: Glucobay
100 mg acarbose5 mg saxagliptin + 100 mg acarbose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptinAcarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD of Department of Endocrinology

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 12, 2014

Study Start

April 3, 2015

Primary Completion

August 26, 2016

Study Completion

August 26, 2016

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

CN(1)