Clinical trial NCT00698932: Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
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 Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise.
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: 2008-06-17
Enrollment: 568
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 with inadequate glycaemic control with diet and exercise.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Patients should be drug naïve ie, not received medical treatment for diabetes,
* HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

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 (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline, Week 24
measure: Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline, Week 24
measure: Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
timeFrame: Baseline , Week 24
measure: Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
timeFrame: Baseline , Week 24
measure: Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Research Site
state: Hebei
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: Hyderabaad
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: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Coimbatore
country: India
facility: Research Site
city: Jeonju
country: Korea, Republic of
facility: Research Site
state: Chonbuk
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Makati City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Marikina City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
Study officials:
affiliation: AstraZeneca, Wilmington, USA
name: Peter Öhman, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Wilmington, USA
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.