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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

— SUNSHINE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608724
• Other study ID #: D1680L00008
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2012
• Last updated: December 31, 2015
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2165
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Saxagliptin
oral, 5 mg once a day (Q.D.)

Locations

Country	Name	City	State
China	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	Urumqi
China	Research Site	Wenzhou
China	Research Site	Wuhan
China	Research Site	Wuxi
China	Research Site	Xian
China	Research Site	Zhanjiang
China	Research Site	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion (%) of Patients Achieving HbA1c <7%		Weeks 6, 12, and 24	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG)		Weeks 6, 12, 18, and 24	No
Secondary	Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)		Week 24	No