| Trial ID: | L2581 |
| Source ID: | NCT02227212
|
| Associated Drug: |
Insulin Glargine U300 (New Formulation Of Insulin Glargine) Hoe901
|
| Title: |
Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naïve Patients With T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Insulin glargine U300 (new formulation of insulin glargine) HOE901
|
| Outcome Measures: |
Primary: Ease-of-use / ease of learning questionnaire, Day 1, Day 7 , 4-weeks | Secondary: Change in treatment satisfaction score (sum of items 1, 4, 5, 6, 7, and 8 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4, Baseline, week 4|Change in perception of hyper- and hypoglycemia score (items 2 and 3 from Diabetes Treatment Satisfaction Questionnaire [status]) from baseline to Week 4, Baseline, week 4|Change in fasting plasma glucose (FPG) (mmol/L) from baseline to Week 4, Baseline, week 4|Number of participants with Product Technical Complaints (PTC), Baseline to week 4|Number of participants with adverse events and hypoglycemic events related to PTC, Baseline to week 4|Change in daily insulin dose (U and U/kg) from Day 1 to Week 4 (patient diary), Baseline, week 4|Number of participants with adverse events, screening to week 6|Incidence and frequency of hypoglycemia episodes. Hypoglycemia will be analyzed by hypoglycemia categories as defined by American Diabetes Association, screening to week 6|Potentially clinically significant changes in laboratory evaluations, vital signs, electrocardiogram (ECG), screening, baseline, week 4|Number of participants with site injection site reactions / hypersensitivity reactions, baseline to week 6
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-08
|
| Completion Date: |
2014-11
|
| Results First Posted: |
|
| Last Update Posted: |
2014-12-03
|
| Locations: |
Investigational Site Number 276011, Augsburg, 86150, Germany|Investigational Site Number 276008, Berlin, 10115, Germany|Investigational Site Number 276009, Essen, 45355, Germany|Investigational Site Number 276002, Hamburg, 22607, Germany|Investigational Site Number 276001, Münster, 48145, Germany|Investigational Site Number 276007, Potsdam, 14469, Germany|Investigational Site Number 276004, Wangen, 88239, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02227212
|
