Type 2 DiabetesPhase 3NCT02315495
Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
A Phase 3 study testing Saxagliptin and Acarbose in people with Type 2 Diabetes, run by Zilin Sun at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Saxagliptin and Acarbose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2015to 26 Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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))
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Zhongda Hospital. Institute of Diabetes, Southeast University
Nanjing, Jiangsu
About this study
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Saxagliptin, Acarbose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaxagliptinDrug
Also called Onglyza
AcarboseDrug
Also called Glucobay
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Saxagliptin; Drug: Acarbose |
| 5 mg saxagliptin | Experimental | Acute dosing:
5 mg saxagliptin is given 60 min before a test meal, Receives: Drug: Saxagliptin |
| 100 mg acarbose | Experimental | Acute dosing:
100 mg acarbose is given with a test meal Receives: Drug: Acarbose |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose concentrations at pre-defined intervals
Measured: -60,-10,0,30,60,90,120,180min
Secondary outcomes (5)
Plasma concentrations of incretin hormones at pre-defined intervals
Measured: -60,-10,0,30,60,90,120,180min
Plasma concentrations of insulin at pre-defined intervals
Measured: -60,-10,0,30,60,90,120,180min
Plasma concentrations of C-peptide at pre-defined intervals
Measured: -60,-10,0,30,60,90,120,180min
Plasma concentrations of glucagon at pre-defined intervals
Measured: -60,-10,0,30,60,90,120,180min
half-emptying time (T50)
Measured: 0-180min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study start3 Apr 2015
- Primary completion26 Aug 2016
- Study completion26 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zilin Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zilin Sun, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315495
- Sponsor's protocol ID
- ISSSAXA0015
- Status last verified
- Jul 2018
- First submitted
- 3 Dec 2014
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Saxagliptin and Acarbose to Improve Postprandial Glycaemia in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02315495
- Acronym / sponsor ID
- ISSSAXA0015
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Zilin SunUniversity, hospital or other
- Study start
- 3 Apr 2015
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- 26 Aug 2016 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg saxagliptin + 100 mg acarbose | Experimental | Drug: Saxagliptin, Drug: AcarboseAcute dosing: 5 mg saxagliptin is given with water, 60 min before a test meal 100 mg acarbose is given with a test meal |
| 5 mg saxagliptin | Experimental | Drug: SaxagliptinAcute dosing: 5 mg saxagliptin is given 60 min before a test meal, |
| 100 mg acarbose | Experimental | Drug: AcarboseAcute dosing: 100 mg acarbose is given with a test meal |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (12 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SaxagliptinAlso: Onglyza | Drug | 5 mg saxagliptin, 5 mg saxagliptin + 100 mg acarbose |
| AcarboseAlso: Glucobay | Drug | 100 mg acarbose, 5 mg saxagliptin + 100 mg acarbose |
Primary outcome
Blood glucose concentrations at pre-defined intervals
Time frame: -60,-10,0,30,60,90,120,180min
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saxagliptin and Acarbose in people with Type 2 Diabetes, run by Zilin Sun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose concentrations at pre-defined intervals (time frame: -60,-10,0,30,60,90,120,180min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.