Clinical trial NCT00661362: Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
Official title: A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors
HbA1c
Incretins
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-04-18
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Treatment with metformin at a stable dose \>1500 mg/day
* HbA1c ≥ 7.0% and ≤10.0%

Exclusion Criteria:

* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
* Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma

Primary outcomes:
measure: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: Baseline , Week 24
Secondary outcomes:
measure: Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
timeFrame: Baseline , Week 24
measure: Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
timeFrame: Baseline , Week 24
measure: Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
timeFrame: Baseline , Week 24
measure: Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
timeFrame: Baseline , Week 24
measure: Proportion of Patients Achieving a Therapeutic Glycemic Response
timeFrame: Baseline , Week 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shi Jiazhuang
country: China
facility: Research Site
state: Hebei
city: Ha'er Bing
country: China
facility: Research Site
state: Hei Longjiang
city: Wuhan
country: China
facility: Research Site
state: Hu Bei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Dalian
country: China
facility: Research Site
state: Liaoning
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Beijing
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Tianjin
country: China
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Bangalore
country: India
facility: Research Site
city: Seongnam
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Goyang
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Pusan
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Uijeongbu-si
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Peter Ohman, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Deborah Price, MSc
role: STUDY_CHAIR
References:
citation: Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
citation: Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26.