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Clinical Trial Details

Trial ID: L5716
Source ID: NCT02946632
Associated Drug: Triple Combination Therapy
Title: Effectiveness & Tolerability of Novel, Initial Triple Combination Therapy vs Conventional Therapy in Type 2 Diabetes
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type II
Interventions: DRUG: triple combination therapy|DRUG: Stepwise add-on therapy
Outcome Measures: Primary: Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks, 104 weeks | Secondary: ∙ Proportion of patients who met HbA1c < 6.5% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 52 weeks, 52 weeks|Proportion of patients who met HbA1c < 7.0% without hypoglycaemia, weight gain, or discontinuation due to adverse events at 104 weeks, 104 weeks|Change in body HbA1c from baseline to week 104, 104 weeks|Change in body weight from baseline to week 104, 104 weeks|Change in systolic blood pressure from baseline to week 104, 104 weeks|Changes in fat and lean mass from baseline to at 104 weeks, 104 weeks | Other: AEs/SAEs, hypoglycemia, GI trouble, urinary tract infection, genital infection, volume depletion, panreatitis, severe cutaneous events, hypersensitivity reactions) * Vital signs * Collection of clinical chemistry/haematology parameters, 104 weeks
Sponsor/Collaborators: Sponsor: Korea University Anam Hospital | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 104
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-12
Completion Date: 2019-12
Results First Posted:
Last Update Posted: 2016-10-27
Locations: Korea University Anam Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT02946632