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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661362
• Other study ID #: D1680C00006
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2008
• Last updated: February 6, 2012
• Start date: June 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationSouth Korea: Korea Food and Drug Administration (KFDA)India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 570
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
Oral tablet, once daily for 24 weeks
• Placebo
oral tablet, once daily for 24 weeks
• Metformin
oral tablet, once daily for 24 weeks

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  India,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)	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.	Baseline , Week 24	No
Secondary	Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L	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.	Baseline , Week 24	No
Secondary	Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL	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.	Baseline , Week 24	No
Secondary	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	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.	Baseline , Week 24	No
Secondary	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	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.	Baseline , Week 24	No
Secondary	Proportion of Patients Achieving a Therapeutic Glycemic Response	Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24	Baseline , Week 24	No