Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose 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.
ConditionType 2 Diabetes
InterventionDrug: Saxagliptin
Drug: Placebo
Drug: Metformin
PhasePhase 3
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00661362
First ReceivedApril 17, 2008
Last UpdatedFebruary 6, 2012
Last verifiedFebruary 2012

Tracking Information[ + expand ][ + ]

First Received DateApril 17, 2008
Last Updated DateFebruary 6, 2012
Start DateJune 2008
Estimated Primary Completion DateSeptember 2009
Current Primary Outcome MeasuresAbsolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [Time Frame: Baseline , Week 24] [Designated as safety issue: No]Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin 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. *Adjusted for baseline HbA1c.
Current Secondary Outcome Measures
  • Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L [Time Frame: Baseline , Week 24] [Designated as safety issue: No]Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (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. *Adjusted for baseline FPG.
  • Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL [Time Frame: Baseline , Week 24] [Designated as safety issue: No]Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin 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. *Adjusted for baseline FPG.
  • 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 [Time Frame: Baseline , Week 24] [Designated as safety issue: No]Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.
  • 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 [Time Frame: Baseline , Week 24] [Designated as safety issue: No]Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.
  • Proportion of Patients Achieving a Therapeutic Glycemic Response [Time Frame: Baseline , Week 24] [Designated as safety issue: No]Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24

Descriptive Information[ + expand ][ + ]

Brief TitleEvaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes
Official TitleA 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Saxagliptin
Oral tablet, once daily for 24 weeks
Other Names:
OnglyzaDrug: Placebo
oral tablet, once daily for 24 weeks
Drug: Metformin
oral tablet, once daily for 24 weeks
Other Names:
Glucophage
Study Arm (s)
  • Experimental: 1
    Metformin + Saxagliptin
  • Placebo Comparator: 2
    Metformin + Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment570
Estimated Completion DateSeptember 2009
Estimated Primary Completion DateSeptember 2009
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesChina, India, Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number NCT00661362
Other Study ID NumbersD1680C00006
Has Data Monitoring CommitteeYes
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsBristol-Myers Squibb
Investigators Study Director: Peter Ohman, MD AstraZenecaStudy Chair: Deborah Price, MSc AstraZeneca
Verification DateFebruary 2012

Locations[ + expand ][ + ]

Research Site
Hefei, Anhui, China
Research Site
Guangzhou, Guangdong, China
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Shi Jiazhuang, Hebei, China
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Ha'er Bing, Hei Longjiang, China
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Wuhan, Hu Bei, China
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Changsha, Hunan, China
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Nanjing, Jiangsu, China
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Changchun, Jilin, China
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Dalian, Liaoning, China
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Shenyang, Liaoning, China
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Shanghai, Shanghai, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Beijing, China
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Chongqing, China
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Tianjin, China
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Nagpur, Maharashtra, India
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Bangalore, India
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Seongnam, Gyeonggi-do, Korea, Republic of
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Bucheon, Korea, Republic of
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Daegu, Korea, Republic of
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Goyang, Korea, Republic of
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Gwangju, Korea, Republic of
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Incheon, Korea, Republic of
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Pusan, Korea, Republic of
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Seoul, Korea, Republic of
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Uijeongbu-si, Korea, Republic of