Clinical Trial Details
| Trial ID: | L4347 |
| Source ID: | NCT01406717 |
| Associated Drug: | Spil1033 |
| Title: | Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01406717/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: SPIL1033|DRUG: Placebo |
| Outcome Measures: | Primary: Change From Baseline to End of Study in Hemoglobin A1c (HbA1c), 24 weeks|Change From Baseline to End of Study in Fasting Plasma Glucose (FPG), 24 weeks|Count and Percentage of Subjects Positive for Anti-exenatide Antibodies, 24 weeks|Count and Percentage of Subjects With Potentially Immune-related Treatment-emergent Adverse Events (TEAEs), 24 weeks | Secondary: Change From Baseline in 2hour Postprandial Glucose (2-h PPG), 24 weeks|Change From Baseline in Triglycerides, 24 weeks|Change From Baseline in Low Density Lipoproteins, 24 weeks|Change From Baseline in High Density Lipoproteins, 24 weeks|Change in Body Weight, 24 weeks|Subjects Achieving Hemoglobin A1c (HbA1c) < 7%, 24 weeks|Change From Baseline in Very Low Density Lipoproteins, 24 weeks|Change From Baseline in Total Cholesterol, 24 weeks |
| Sponsor/Collaborators: | Sponsor: Sun Pharmaceutical Industries Limited |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 360 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2013-03-01 |
| Completion Date: | 2015-11-04 |
| Results First Posted: | 2019-11-01 |
| Last Update Posted: | 2020-08-11 |
| Locations: | SPIL Site 22, Hyderabad, Andhra Pradesh, India|SPIL Site 25, Hyderabad, Andhra Pradesh, India|SPIL Site 26, Hyderabad, Andhra Pradesh, India|SPIL Site 23, Visakhapatnam, Andhra Pradesh, India|SPIL Site 1, Ahmedabad, Gujrat, India|SPIL Site 2, Ahmedabad, Gujrat, India|SPIL Site 3, Ahmedabad, Gujrat, India|SPIL Site 5, Rajkot, Gujrat, India|SPIL Site 6, Surat, Gujrat, India|SPIL Site 7, Surat, Gujrat, India|SPIL Site 8, Surat, Gujrat, India|SPIL Site 9, Surat, Gujrat, India|SPIL Site 10, Vadodara, Gujrat, India|SPIL Site 19, Bangalore, kARNATAKA, India|SPIL Site 30, Bangalore, Karnataka, India|SPIL Site 31, Bangalore, Karnataka, India|SPIL Site 33, Bangalore, Karnataka, India|SPIL Site 29, Manipal, Karnataka, India|SPIL Site 35, Indore, Madhya Pradesh, India|SPIL Site 21, Nagpur, Maharashtra, India|SPIL Site 24, Nagpur, Maharashtra, India|SPIL Site 32, Nashik, Maharashtra, India|SPIL Site 11, Pune, Maharashtra, India|SPIL Site 12, Pune, Maharashtra, India|SPIL Site 13, Bhubaneshwar, Orrissa, India|SPIL Site 14, Jaipur, Rajasthan, India|SPIL Site 15, Jaipur, Rajasthan, India|SPIL Site 34, Vellore, Tamil Nadu, India|SPIL Site 16, Chennai, Tamilnadu, India|SPIL Site 17, Coimbatore, Tamilnadu, India|SPIL Site 20, Coimbatore, Tamilnadu, India|SPIL Site 18, Madurai, Tamilnadu, 625020, India|SPIL Site 27, Lucknow, Uttar Pradesh, India|SPIL Site 28, Lucknow, Uttar Pradesh, India |
| URL: | https://clinicaltrials.gov/show/NCT01406717 |
