| Trial ID: | L1954 |
| Source ID: | NCT04980027
|
| Associated Drug: |
Insulin Glargine (U300)
|
| Title: |
Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs
|
| Acronym: |
SAFEGUARD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Insulin glargine (U300)
|
| Outcome Measures: |
Primary: Percentage of participants with Treatment Emergent Adverse Events (TEAEs), TEAEs including serious adverse events (SAEs) and hypoglycemic episode, Baseline to Week 24 | Secondary: Percentage of participants with at least one confirmed hypoglycemia event, Baseline to Week 24|Change in HbA1c from Baseline to week 12 and week 24, Baseline to Week 12 and Week 24|Percentage of participants reaching HbA1c target of <7%, Week 12 and Week 24|Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L), Week 12 and Week 24|Change in fasting plasma glucose (FPG) from Baseline to Week 24, Baseline to Week 24|Change in fasting SMBG from Baseline to Week 24, Baseline to Week 24|Change in 7-point SMBG profile from Baseline to Week 24, Baseline to Week 24|Percentage of participants requiring rescue therapy, Week 12 and Week 24|Change in body weight from Baseline to Week 12 and Week 24, Baseline to Week 12 and Week 24|Change in insulin dose from Baseline to Week 12 and Week 24, Baseline to Week 12 and Week 24|Change in DTSQs scores from Baseline to Week 12 and Week 24, The Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) is measuring patients' satisfaction with their diabetes treatment.Total treatment satisfaction score range from 0 (no satisfaction) to 36 (improvement in treatment satisfaction), Baseline to Week 12 and Week 24
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
228
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2021-06-07
|
| Completion Date: |
2022-12-23
|
| Results First Posted: |
|
| Last Update Posted: |
2023-01-31
|
| Locations: |
Investigational site Number 3560003, Jaipur, 302017, India|Investigational site Number 3560013, Nasik, 422002, India
|
| URL: |
https://clinicaltrials.gov/show/NCT04980027
|
