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Clinical Trial Details

Trial ID: L4327
Source ID: NCT03421119
Associated Drug: Liraglutide 6 Mg/Ml Pen Injector
Title: Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Liraglutide 6 MG/ML Pen Injector|DRUG: Metformin|DRUG: Sulfonylurea/non-sulfonylurea insulin secretagogues
Outcome Measures: Primary: HbA1c, The primary outcome of this study is to assess changes in HbA1c in both treatment arms, 26 weeks | Secondary: HbA1c < 7.0%, Percentages of subjects achieving HbA1c \< 7.0% is measured in both treatment arms, 26 weeks|HbA1c ≤ 6.5%, Percentages of subjects achieving HbA1c ≤ 6.5% is measured in both treatment arms, 26 weeks|Body weight, Changes in body weight is measured in both treatment arms, 26 weeks|Fasting blood sugar, Changes in FBS is measured in both treatment arms, 26 weeks|Postprandial glucose, Changes in mean PPG is measured in both treatment arms, 26 weeks|Systolic blood pressure, Changes in SBP (mmHg) is measured in both treatment arms, 26 weeks|Diastolic blood pressure, Changes in DBP (mmHg) is measured in both treatment arms, 26 weeks|Lipid profiles, Changes in Lipid profiles is measured in both treatment arms, 26 weeks|Pulse Rate, Changes in PR is measured in both treatment arms, 26 weeks|estimated Glomerular Filtration Rate, Changes in eGFR is measured in both treatment arms, 26 weeks|Liver enzymes, Changes in AST and ALT is measured in both treatment arms, 26 weeks
Sponsor/Collaborators: Sponsor: Cinnagen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2019-06-20
Completion Date: 2019-12-01
Results First Posted:
Last Update Posted: 2019-02-06
Locations:
URL: https://clinicaltrials.gov/show/NCT03421119