Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control
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.
1 other identifier
interventional
568
4 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Jun 2008
Shorter than P25 for phase_3 type-2-diabetes
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 16, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
September 21, 2011
CompletedSeptember 21, 2011
August 1, 2011
1.3 years
June 16, 2008
September 20, 2010
August 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
Baseline, Week 24
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
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
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
Baseline , Week 24
Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24
Baseline, Week 24
Study Arms (2)
Saxagliptin 5mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (30)
Research Site
Hefei, Anhui, China
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
Research Site
Shenyang, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Chengdu, Sichuan, China
Research Site
Hangzhou, Zhejiang, China
Research Site
Tianjin, China
Research Site
Hyderabaad, Andhra Pradesh, India
Research Site
Bangalore, Karnataka, India
Research Site
Mangalore, Karnataka, India
Research Site
Mumbai, Maharashtra, India
Research Site
Nagpur, Maharashtra, India
Research Site
Pune, Maharashtra, India
Research Site
Coimbatore, India
Research Site
Cebu City, Philippines
Research Site
Makati City, Philippines
Research Site
Manila, Philippines
Research Site
Marikina City, Philippines
Research Site
Quezon City, Philippines
Research Site
Jeonju, Jeollabuk-do, South Korea
Research Site
Daegu, South Korea
Research Site
Seoul, South Korea
Related Publications (1)
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.
PMID: 27402391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Peter Öhman, MD, PhD
AstraZeneca, Wilmington, USA
- STUDY CHAIR
Deborah Price, MSc
AstraZeneca, Wilmington, USA
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2008
First Posted
June 17, 2008
Study Start
June 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
September 21, 2011
Results First Posted
September 21, 2011
Record last verified: 2011-08