Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

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 Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698932
• Other study ID #: D1680C00005
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2008
• Last updated: August 17, 2011
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationIndia: Drugs Controller General of IndiaPhilippines: Bureau of Food and DrugsSouth Korea: Korea Food and Drug Administration (KFDA)
• 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 with inadequate glycaemic control with diet and exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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
5mg, oral tablet, once daily for 24 weeks
• Placebo
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	Fuzhou	Fujian
China	Research Site	Guangzhou	Guangdong
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	Shijiazhuang	Hebei
China	Research Site	Tianjin
India	Research Site	Bangalore	Karnataka
India	Research Site	Coimbatore
India	Research Site	Hyderabaad	Andhra Pradesh
India	Research Site	Mangalore	Karnataka
India	Research Site	Mumbai	Maharashtra
India	Research Site	Nagpur	Maharashtra
India	Research Site	Pune	Maharashtra
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Jeonju	Chonbuk
Korea, Republic of	Research Site	Seoul
Philippines	Research Site	Cebu City
Philippines	Research Site	Makati City
Philippines	Research Site	Manila
Philippines	Research Site	Marikina City
Philippines	Research Site	Quezon City

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  India,  Korea, Republic of,  Philippines, 

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 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.	Baseline , Week 24	No
Secondary	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.	Baseline, Week 24	No
Secondary	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.	Baseline, Week 24	No
Secondary	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	Baseline , Week 24	No
Secondary	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	Baseline , Week 24	No
Secondary	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	Baseline, Week 24	No