Clinical trial NCT01608724: The Efficacy and Safety Study in Patients With Type 2 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Type 2 DM
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 2165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Absolute Change From Baseline in Haemoglobin A1c (HbA1c)
timeFrame: Weeks 6, 12, and 24
Secondary outcomes:
measure: Proportion (%) of Patients Achieving HbA1c <7%
timeFrame: Weeks 6, 12, and 24
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Weeks 6, 12, 18, and 24
measure: Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)
timeFrame: Week 24
Other outcomes:
Locations:
city: Baotou
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Benxi
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Dalian
country: China
facility: Research Site
city: Dongguan
country: China
facility: Research Site
city: Foshan
country: China
facility: Research Site
city: Fuzhou
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Guiyang
country: China
facility: Research Site
city: Haikou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hhht
country: China
facility: Research Site
city: Hubei
country: China
facility: Research Site
city: Jimo
country: China
facility: Research Site
city: Jinan
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Linyi
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Nantong
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shantou
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shiyan
country: China
facility: Research Site
city: Suzhou
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Urumqi
country: China
facility: Research Site
city: Wenzhou
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuxi
country: China
facility: Research Site
city: Xian
country: China
facility: Research Site
city: Zhanjiang
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Simon Fisher
role: STUDY_DIRECTOR
References: