Type 2 Diabetes MellitusPhase 4SMARTNCT02243176

24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With T2D Inadequately Controlled With Metformin Monotherapy

A Phase 4 study testing Saxagliptin and Acarbose in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared with Acarbose when in Combination with Metformin in Patients with Type 2 Diabetes Mellitus (T2D) Inadequately Controlled with Metformin… Read more about this study

Who is it for?: Ages 18 to 150 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Saxagliptin and Acarbose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 689 participants
Where: 1 siteChina
Study dates: Sep 2014to Sep 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 150 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with type 2 diabetes mellitus
Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening.
T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated dose), but not more than the maximum dose specified in the label
HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central laboratory)
FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)
Able and willing to provide written informed consent and to comply with the study protocol

Who cannot join

Women who are pregnant, intending to become pregnant during the study period, lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
Diagnosis or history of:
Type 1 diabetes mellitus, diabetes resulting from pancreatic injury or secondary forms of diabetes, eg, acromegaly or Cushing's syndrome.
Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months.
Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year.
History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening

Trial locations and contacts

1 site in 1 country.

China1 site

Research Site
Shanghai

Other trials in China

About this study

Official title: SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With Type 2 Diabetes Mellitus (T2D) Inadequately Controlled With Metformin Monotherapy

Conditions: Type 2 Diabetes Mellitus
Being tested: Saxagliptin, Acarbose
Keywords: Saxagliptin, Acarbose, Type 2 Diabetes, Metformin
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
The dose of saxaglitpin will be 5mg oral qd.
AcarboseDrug
Also called Glucobay
Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.

Study groups in NCT02243176
Study group	Role	What they receive
Saxagliptin	Experimental	The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm. Receives: Drug: Saxagliptin
Acarbose	Active comparator	Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm. Receives: Drug: Acarbose

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Change From Baseline in HbA1c at Week 24 (DAO)
Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24
Measured: From baseline to 24 week
Absolute Change From Baseline in HbA1c at Week 24 (DAO)
The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.
Measured: From baseline to 24 week

Secondary outcomes (7)

Proportion (%) of Patients With Any GI Adverse Events
Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.
Measured: 24 weeks
Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%
Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c<7.0%
Measured: 24 weeks
Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events
Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c<7.0% without GI adverse events.
Measured: Whole study duration
Change From Baseline in Fasting Plasma Glucose (FPG)
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24
Measured: From baseline to 24 week
Change From Baseline in 2H Postprandial Glucose (2HPPG)
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24
Measured: From baseline to 24 week
Change From Baseline in HOMA-β
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24
Measured: From baseline to 24 week
Change From Baseline in Body Weight
Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24
Measured: From baseline to 24 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Sep 2015

First posted17 Sep 2014 (estimated)
Study startSep 2014
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 689 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02243176
Sponsor's protocol ID: D1680L00018
Acronym: SMART
Status last verified: Mar 2017
First submitted: 16 Sep 2014
Last updated: 14 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Du J, Liang L, Fang H, Xu F, Li W, Shen L, Wang X, Xu C, Bian F, Mu Y. Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study). Diabetes Obes Metab. 2017 Nov;19(11):1513-1520. doi: 10.1111/dom.12942. Epub 2017 Jul 6.
PubMed 28296055

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SMART Study - A 24-Week, Multicenter, Randomized, Parallel-group, Open-label, Active Controlled Phase IV Study to Assess the Efficacy, Safety and Tolerability of Saxagliptin Compared With Acarbose When in Combination With Metformin in Patients With Type 2 Diabetes Mellitus (T2D) Inadequately Controlled With Metformin Monotherapy
ClinicalTrials.gov ID: NCT02243176
Acronym / sponsor ID: SMART / D1680L00018
Conditions: Type 2 Diabetes Mellitus
Keywords: Saxagliptin, Acarbose, Type 2 Diabetes, Metformin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 689 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 17 Sep 2014 (estimated)
Results: Posted 14 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Saxagliptin	Experimental	Drug: SaxagliptinThe dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
Acarbose	Active comparator	Drug: AcarbosePatients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.

Who may qualify

Ages: 18 to 150 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosed with type 2 diabetes mellitus
Men and women (non-pregnant and using a medically approved birth-control method) aged at least 18 years at screening.
T2D patients treated with stable metformin monotherapy for at least 8 weeks prior to screening. Metformin dose should be ≥ 1500 mg/day (or individual maximally tolerated dose), but not more than the maximum dose specified in the label
HbA1c ≥ 7.5% and ≤ 11.0% at screening or within 4 weeks prior to screening (by local laboratory) and HbA1c ≥ 7.0% and ≤ 11.0% at pre-randomization visit (by central laboratory)
FPG ≤ 13.3 mmol/L (≤ 240 mg/dL) at pre-randomization visit (by central laboratory)

Key exclusion criteria (7 listed)

Women who are pregnant, intending to become pregnant during the study period, lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods.
Diagnosis or history of:
Previous treatment with any dipeptidyl peptidase-4 (DPP4) inhibitor or GLP-1 receptor agonists within the past one year.
History of hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to dipeptidyl peptidase-4 inhibitor (DPP4) or Acarbose.
Treatment with any anti-diabetic medication for more than 7 consecutive days other than metformin in the last 8 weeks prior to screening

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: OnglyzaThe dose of saxaglitpin will be 5mg oral qd.	Drug	Saxagliptin
AcarboseAlso: GlucobayPatients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.	Drug	Acarbose

Primary outcome

Absolute Change From Baseline in HbA1c at Week 24 (DAO)
Time frame: From baseline to 24 week
Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24
Absolute Change From Baseline in HbA1c at Week 24 (DAO)
Time frame: From baseline to 24 week
The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.

7 secondary outcomes

Proportion (%) of Patients With Any GI Adverse Events
Time frame: 24 weeks
Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%
Time frame: 24 weeks
Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events
Time frame: Whole study duration
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: From baseline to 24 week
Change From Baseline in 2H Postprandial Glucose (2HPPG)
Time frame: From baseline to 24 week
Change From Baseline in HOMA-β
Time frame: From baseline to 24 week
Change From Baseline in Body Weight
Time frame: From baseline to 24 week

Results and safety

Results posted to the registry on 14 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saxagliptin	244	230
Acarbose	244	229

Primary outcome: Absolute Change From Baseline in HbA1c at Week 24 (DAO)

Time frame: From baseline to 24 week. Least squares mean (Standard Error). Unit: % (HbA1c)

Measure	Saxagliptin n = 238	Acarbose n = 243
Value	-0.82 (0.06)	-0.78 (0.06)

Saxagliptin vs Acarbose: Mean Difference (Final Values): -0.04 (95% CI -0.22 to 0.13), p = 0.6236, Mixed Model Repeated Measures

Population analysed: The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.

Primary outcome: Absolute Change From Baseline in HbA1c at Week 24 (DAO)

Time frame: From baseline to 24 week. Least squares mean (Standard Error). Unit: % (HbA1c)

Measure	Saxagliptin n = 219	Acarbose n = 204
Value	-0.83 (0.06)	-0.80 (0.07)

Saxagliptin vs Acarbose: Mean Difference (Final Values): -0.03 (95% CI -0.21 to 0.15), p = 0.7809, Mixed Model Repeated Measures

Population analysed: The Per Protocol analysis set was a subset of the Full analysis set that included subjects who did not have significant protocol deviations that affect the study outcome. The exclusions from the PP analysis set was determined prior to database lock.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from time of signature of informed consent, throughout the treatment period. That was about 28 weeks for every subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saxagliptin	5 of 241 (2.1%)	27 of 241 (11.2%)	Not reported
Acarbose	2 of 244 (0.8%)	74 of 244 (30.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28296055Du J, Liang L, Fang H, Xu F, Li W, Shen L, Wang X, Xu C, Bian F, Mu Y. Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study). Diabetes Obes Metab. 2017 Nov;19(11):1513-1520. doi: 10.1111/dom.12942. Epub 2017 Jul 6.

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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 4 study testing Saxagliptin and Acarbose in people with Type 2 Diabetes Mellitus, run by AstraZeneca 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 7 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 14 Apr 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Absolute Change From Baseline in HbA1c at Week 24 (DAO) (time frame: From baseline to 24 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02243176, which also lists 1 linked publication.

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 14 Apr 2017.