Study S003408

Safety and Efficacy of SPIL1033 in Subjects With Type 2 Diabetes Mellitus

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT01406717
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 360
Start: 2013-03-01
Primary completion: 2015-11-04
Lead sponsor: Sun Pharmaceutical Industries Limited
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:SPIL1033; DRUG:Placebo
Results posted: TRUE

Registered primary outcomes

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]

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