Diabetes Mellitus, Non-Insulin-DependentPhase 4SUNSHINENCT01608724

The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus

A Phase 4 study testing Saxagliptin in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 37 sites 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

The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?: Saxagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,165 participants
Where: 37 sitesChina
Study dates: Nov 2012to May 2014
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 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes
Men or women who are >18 years of age at time of consenting upon Visit 1
HbA1c >7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1
Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)

Who cannot join

Pregnant or breastfeeding patients
Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Previous treatment with any DPP-IV inhibitors or GLP-1 analogue
History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD)
Treatment with systemic glucocorticoids other than replacement therapy
Inhaled, local injected and topical use of glucocorticoids is allowed

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

China37 sites

Research Site
Baotou
Research Site
Beijing
Research Site
Benxi
Research Site
Changchun
Research Site
Chengdu
Research Site
Chongqing
Research Site
Dalian
Research Site
Dongguan
Research Site
Foshan
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Guiyang
Research Site
Haikou
Research Site
Hangzhou
Research Site
Hhht
Research Site
Hubei
Research Site
Jimo
Research Site
Jinan
Research Site
Kunming
Research Site
Linyi
Research Site
Nanjing
Research Site
Nantong
Research Site
Qingdao
Research Site
Shanghai
Research Site
Shantou
Research Site
Shenyang
Research Site
Shiyan
Research Site
Suzhou
Research Site
Taiyuan
Research Site
Tianjin
Research Site
Ürümqi
Research Site
Wenzhou
Research Site
Wuhan
Research Site
Wuxi
Research Site
Xi'an
Research Site
Zhanjiang
Research Site
Zhengzhou

Other trials in China

About this study

Official title: A Multicenter, Single Arm, Cohort Study to Evaluate the Efficacy and Safety of Saxagliptin 5mg, Once Daily for 24 Weeks, in Patients With Type 2 Diabetes Mellitus

The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.

Read the detailed description

A multicenter, single arm, cohort study to evaluate the Efficacy and Safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone

Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Being tested: Saxagliptin
Keywords: Type 2 DM
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
oral, 5 mg once a day (Q.D.)

Study groups in NCT01608724
Study group	Role	What they receive
Open label	Experimental	Saxagliptin, oral 5mg once a day(Q. D.) Receives: Drug: Saxagliptin

What is being measured

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

Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.
Measured: Weeks 6, 12, and 24

Secondary outcomes (3)

Proportion (%) of Patients Achieving HbA1c <7%
Measured: Weeks 6, 12, and 24
Change From Baseline in Fasting Plasma Glucose (FPG)
Measured: Weeks 6, 12, 18, and 24
Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
Measured: Week 24

Timeline

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

Nov 2012May 2014

First posted31 May 2012 (estimated)
Study startNov 2012
Primary completionMay 2014
Study completionMay 2014

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.
Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01608724
Sponsor's protocol ID: D1680L00008
Acronym: SUNSHINE
Status last verified: Dec 2015
First submitted: 28 May 2012
Last updated: 2 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
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All Diabetes Mellitus, Non-Insulin-Dependent trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Single Arm, Cohort Study to Evaluate the Efficacy and Safety of Saxagliptin 5mg, Once Daily for 24 Weeks, in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01608724
Acronym / sponsor ID: SUNSHINE / D1680L00008
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 DM
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,165 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2012
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 31 May 2012 (estimated)
Results: Posted 2 Feb 2016

Clinical summary

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

The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open label	Experimental	Drug: SaxagliptinSaxagliptin, oral 5mg once a day(Q. D.)

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Provision of informed consent prior to any study specific procedures Diagnosed with type 2 diabetes
Men or women who are >18 years of age at time of consenting upon Visit 1
HbA1c >7.5% and ≤11.0% Patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to Visit 1
Drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo)

Key exclusion criteria (6 listed)

Pregnant or breastfeeding patients
Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Previous treatment with any DPP-IV inhibitors or GLP-1 analogue
History of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to Visit 1(12 weeks for previous TZD)
Treatment with systemic glucocorticoids other than replacement therapy

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: Onglyzaoral, 5 mg once a day (Q.D.)	Drug	Open label

Primary outcome

Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
Time frame: Weeks 6, 12, and 24
Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.

3 secondary outcomes

Proportion (%) of Patients Achieving HbA1c <7%
Time frame: Weeks 6, 12, and 24
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Weeks 6, 12, 18, and 24
Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
Time frame: Week 24

Results and safety

Results posted to the registry on 2 Feb 2016, 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	1,423	1,180

Primary outcome: Absolute Change From Baseline in Haemoglobin A1c (HbA1c)

Time frame: Weeks 6, 12, and 24. Mean (Standard Error). Unit: (%)

Measure	Saxagliptin n = 1210
Week 6	-1.19 (0.033)
Week 12	-1.59 (0.039)
Week 24	-1.61 (0.040)

Population analysed: Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saxagliptin	24 of 1,361 (1.8%)	69 of 1,361 (5.1%)	Not reported

Limitations and caveats (from the sponsor): This was a single-arm study and thus potential placebo effect was unable to be adjusted in any efficacy analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetes Mellitus, Non-Insulin-Dependent

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction

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.

Simon Fisher study director

AstraZeneca

37 sites 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 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 37 sites 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 4 inclusion and 6 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites 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 2 Feb 2016). 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 Haemoglobin A1c (HbA1c) (time frame: Weeks 6, 12, and 24). 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 NCT01608724.

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 2 Feb 2016.