The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
SUNSHINE
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
1 other identifier
interventional
2,165
1 country
37
Brief Summary
The efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2012
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
February 2, 2016
CompletedFebruary 2, 2016
December 1, 2015
1.5 years
May 28, 2012
May 14, 2015
December 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Weeks 6, 12, and 24
Secondary Outcomes (3)
Proportion (%) of Patients Achieving HbA1c <7%
Weeks 6, 12, and 24
Change From Baseline in Fasting Plasma Glucose (FPG)
Weeks 6, 12, 18, and 24
Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
Week 24
Study Arms (1)
Open label
EXPERIMENTALSaxagliptin, oral 5mg once a day(Q. D.)
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (37)
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Benxi, China
Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Dalian, China
Research Site
Dongguan, China
Research Site
Foshan, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guiyang, China
Research Site
Haikou, China
Research Site
Hangzhou, China
Research Site
Hhht, China
Research Site
Hubei, China
Research Site
Jimo, China
Research Site
Jinan, China
Research Site
Kunming, China
Research Site
Linyi, China
Research Site
Nanjing, China
Research Site
Nantong, China
Research Site
Qingdao, China
Research Site
Shanghai, China
Research Site
Shantou, China
Research Site
Shenyang, China
Research Site
Shiyan, China
Research Site
Suzhou, China
Research Site
Taiyuan, China
Research Site
Tianjin, China
Research Site
Ürümqi, China
Research Site
Wenzhou, China
Research Site
Wuhan, China
Research Site
Wuxi, China
Research Site
Xi'an, China
Research Site
Zhanjiang, China
Research Site
Zhengzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This was a single-arm study and thus potential placebo effect was unable to be adjusted in any efficacy analyses.
Results Point of Contact
- Title
- Anya Huang, Brand Physician
- Organization
- Astrazeneca Investment (China) Co., Ltd.
Study Officials
- STUDY DIRECTOR
Simon Fisher
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2012
First Posted
May 31, 2012
Study Start
November 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
February 2, 2016
Results First Posted
February 2, 2016
Record last verified: 2015-12