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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
568
5mg, oral tablet, once daily for 24 weeks
oral tablet, once daily for 24 weeks
Research Site
Hefei, Anhui, China
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.
Time frame: Baseline , Week 24
Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Time frame: Baseline, Week 24
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. FPG data were excluded on and after rescue medication.
Time frame: Baseline, Week 24
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
Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
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Research Site
Beijing, China, China
Research Site
Chongqing, China, China
Research Site
Fuzhou, Fujian, China
Research Site
Guangzhou, Guangdong, China
Research Site
Shijiazhuang, Hebei, China
Research Site
Changsha, Hunan, China
Research Site
Nanjing, Jiangsu, China
Research Site
Changchun, Jilin, China
Research Site
Dalian, Liaoning, China
...and 20 more locations
Time frame: Baseline , Week 24
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
Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication
Time frame: Baseline , Week 24
Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24
Proportion of participants (expressed in percentage of total participants) achieving HbA1c \< 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication
Time frame: Baseline, Week 24