| Trial ID: | L5659 |
| Source ID: | NCT04538352
|
| Associated Drug: |
Semaglutide
|
| Title: |
Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D
|
| Acronym: |
TRANSITION-T2D
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04538352/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Semaglutide|DRUG: Insulin Degludec|DRUG: Insulin aspart
|
| Outcome Measures: |
Primary: Mean Change in HbA1C ≤ 7.5%, Mean change in HbA1C ≤ 7.5% from baseline to 26 weeks between the two groups, 26 weeks | Secondary: Mean Weight Change, Mean weight change from baseline in body weight at 26 weeks, 26 weeks|Hypoglycemic Episodes, Recorded for the overall study period, 26 weeks|Mean Change From Baseline in A1C, Change from baseline in A1C at week 26, 26 weeks|Diabetes Treatment Satisfaction Comparison Between Groups, Change from baseline in diabetes treatment satisfaction at week 26, 26 weeks|Total Daily Insulin Dose, Mean total insulin dose change (U/day) from baseline to week 26, 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: The Cleveland Clinic | Collaborators: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-01-18
|
| Completion Date: |
2023-11-01
|
| Results First Posted: |
2024-07-29
|
| Last Update Posted: |
2025-02-18
|
| Locations: |
Cleveland Clinic, Cleveland, Ohio, 44195, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04538352
|