| Trial ID: | L5194 |
| Source ID: | NCT00918879
|
| Associated Drug: |
Saxagliptin
|
| Title: |
Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00918879/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Saxagliptin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c), Adjusted\* mean change from baseline in glycosylated haemoglobin A1c (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: Absolute Change 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|Proportion of Patients (Expressed in Percentage of Total Participants) 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 (LOCF, Full Analysis set). HbA1c data were excluded on and after rescue medication, Baseline , Week 24
|
| Sponsor/Collaborators: |
Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
213
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-05
|
| Completion Date: |
2010-07
|
| Results First Posted: |
2011-09-26
|
| Last Update Posted: |
2011-09-26
|
| Locations: |
Research Site, Gujarat, Ahmedabad, India|Research Site, Karnataka, Bangalore, India|Research Site, Tamil Nadu, Chennai, India|Research Site, Tamil Nadu, Coimbatore, India|Research Site, Andhra Pradesh, Hyderabad, India|Research Site, Madhya Pradesh, Indore, India|Research Site, Haryana, Karnal, India|Research Site, Kerala, Kochi, India|Research Site, Maharashtra, Pune, India
|
| URL: |
https://clinicaltrials.gov/show/NCT00918879
|
