Clinical Trial Details
| Trial ID: | L3934 |
| Source ID: | NCT01257412 |
| Associated Drug: | Dapagliflozin |
| Title: | Evaluation of Efficacy and Safety of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise Alone |
| Acronym: | |
| Status: | SUSPENDED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: Dapagliflozin|DRUG: Dapagliflozin|DRUG: placebo |
| Outcome Measures: | Primary: change in glycosylated haemoglobin A1c (HbA1c)., From baseline to week 24 | Secondary: mean change in fasting plasma glucose (FPG), From baseline to week 24|mean change in 2- hour postprandial glucose by Mixed Meal Test, From baseline to week 24|mean change from baseline in fasting plasma glucose (FPG), From baseline to week 1 |
| Sponsor/Collaborators: | Sponsor: AstraZeneca | Collaborators: Bristol-Myers Squibb |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 375 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-01 |
| Completion Date: | 2013-06 |
| Results First Posted: | |
| Last Update Posted: | 2012-03-01 |
| Locations: | Research Site, Hyderabad, Andhra Pradesh, India|Research Site, Vijaywada, Andhra Pradesh, India|Research Site, Ahmedabad, Gujarat, India|Research Site, Bangalore, Karnataka, India|Research Site, Mysore, Karnataka, India|Research Site, Trivandrum, Kerala, India|Research Site, Indore, Madhya Pradesh, India|Research Site, Mumbai, Maharashtra, India|Research Site, Nagpur, Maharashtra, India|Research Site, Pune, Maharashtra, India|Research Site, Jaipur, Rajasthan, India|Research Site, Chennai, Tamil Nadu, India|Research Site, Coimbatore, Tamil Nadu, India|Research Site, Madurai, Tamil Nadu, India|Research Site, Ghaziabad, Uttar Pradesh, India |
| URL: | https://clinicaltrials.gov/show/NCT01257412 |
