| Trial ID: | L2465 |
| Source ID: | NCT03760991
|
| Associated Drug: |
Insulin Glargine (U300)
|
| Title: |
Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin
|
| Acronym: |
ARTEMIS-DM
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: INSULIN GLARGINE (U300)
|
| Outcome Measures: |
Primary: Change in glycated hemoglobin (HbA1c), Absolute change in HbA1c, Baseline to Week 26 | Secondary: Change in glycated hemoglobin (HbA1c), Absolute change in HbA1c, Baseline to Week 12|Participants with HbA1c below 7%, Percentage of participants with HbA1c below 7%, Week 12 and 26|Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L), Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L), Week 12 and 26|Change in fasting SMPG, Absolute change in fasting SMPG, Baseline to Week 26|Change in SMPG profile, Absolute change in SMPG profile, Baseline to Week 26|Change in fasting plasma glucose (FPG), Absolute change in FPG, Baseline to Week 26|Percentage of participants requiring rescue therapy, Percentage of participants requiring rescue therapy by additional antidiabetic medication, Baseline to Week 12 and 26|Number of participants with hypoglycemia events, Number of participants with at least 1 hypoglycemia event, Baseline to Week 26|Number of participants with adverse events (AEs), Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness)., Baseline to Week 27|Change in Treatment satisfaction, Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire, Baseline to Week 26|Number of participants with health care utilization, Number of participants with health care utilization, including hospitalization, emergency room visits, and office \[or specialty\] visits, Baseline to Week 26
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
372
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2018-12-18
|
| Completion Date: |
2020-09-23
|
| Results First Posted: |
|
| Last Update Posted: |
2022-04-25
|
| Locations: |
Investigational site Argentina, Buenos Aires, Argentina|investigational site COLOMBIA, Colombia, Colombia|investigational site Egypt, Egypt, Egypt|investigational site HONG KONG, Hong Kong, Hong Kong|investigational site INDIA, India, India|Investigational site Indonesia, Indonesia, Indonesia|investigational site LEBANON, Lebanon, Lebanon|Investigational site Malaysia, Putrajaya, Malaysia|Investigational site PERU, Peru, Peru|investigational site PHILIPPINES, Philippines, Philippines|Investigational site Saudi Arabia, Saudi Arabia, Saudi Arabia|Investigational site South Africa, South Africa, South Africa|Investigational site Thailand, Thailand, Thailand|investigational site TURKEY, Turkey, Turkey
|
| URL: |
https://clinicaltrials.gov/show/NCT03760991
|
