Clinical Trial Details
| Trial ID: | L2825 |
| Source ID: | NCT03070704 |
| Associated Drug: | Insulin Degludec/Liraglutide |
| Title: | Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India |
| Acronym: | |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes|Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: insulin degludec/liraglutide |
| Outcome Measures: | Primary: Incidence of treatment emergent Adverse Events (AEs), Count and % of events, Year 0-1 | Secondary: Number of Serious Adverse Events (SAEs), Count and % of events, Year 0-1|Number of Serious Adverse Drug Reactions (SADRs), Count and % of events, Year 0-1|Number of Adverse Drug Reactions (ADRs), Count and % of events, Year 0-1|Number of confirmed hypoglycaemic episodes, Count of episodes, Year 0-1|Change from baseline in the level of glycosylated haemoglobin (HbA1c), Measured in %, Year 0, Year 1|Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline, Measured in mg/dl or other equivalent SI units, Year 0, Year 1|Percentage of patients achieving the target level of HbA1c below 7%, Measured in %, Year 1|Change in body weight, Measured in kg and/or %, Year 0, Year 1|Number of patients withdrawn due to ineffective therapy, Count of withdrawals, Year 1 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 0 |
| Study Type: | OBSERVATIONAL |
| Study Designs: | Observational Model: |Time Perspective: p |
| Start Date: | 2017-08-16 |
| Completion Date: | 2019-08-16 |
| Results First Posted: | |
| Last Update Posted: | 2017-09-05 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT03070704 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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