Clinical Trial Details
| Trial ID: | L2631 |
| Source ID: | NCT02954692 |
| Associated Drug: | Insulin Glargine (U300) |
| Title: | A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey |
| Acronym: | EASE |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: INSULIN GLARGINE (U300)|DRUG: metformin|DRUG: sulfonylurea|DRUG: meglitinides|DRUG: thiazolidinediones|DRUG: alpha-glucosidase inhibitors|DRUG: GLP1 Receptor Agonist|DRUG: Dipeptidyl peptidase-IV (DPP-IV) inhibitors|DRUG: Sodium-glucose transport-2 (SGLT-2) inhibitors |
| Outcome Measures: | Primary: Mean change from baseline in HbA1c, Baseline, Week 24 | Secondary: Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL, At Weeks 12 and 24|Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL), At Weeks 12 and 24|Duration to reach target pre-breakfast SMBG, Baseline, Week 24|Mean change from baseline in HbA1c, Baseline, Week 12|Mean change from baseline in SMBG, Baseline, Weeks 12, and 24|Mean change from baseline in fasting plasma glucose (FPG), Baseline, Weeks 12, and 24|Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores, Baseline, Week 24 |
| Sponsor/Collaborators: | Sponsor: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 112 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-11-30 |
| Completion Date: | 2017-12-22 |
| Results First Posted: | |
| Last Update Posted: | 2019-01-14 |
| Locations: | Turkey, Turkey |
| URL: | https://clinicaltrials.gov/show/NCT02954692 |
