Primary Objective: To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300. Secondary Objectives: To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes. To evaluate the safety of Gla-300.
Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
372
Pharmaceutical form: Solution for injection in a prefilled pen Route of administration: Subcutaneous
Investigational site Argentina
Buenos Aires, Argentina
investigational site COLOMBIA
Colombia, Colombia
investigational site Egypt
Egypt, Egypt
Change in glycated hemoglobin (HbA1c)
Absolute change in HbA1c
Time frame: Baseline to Week 26
Change in glycated hemoglobin (HbA1c)
Absolute change in HbA1c
Time frame: Baseline to Week 12
Participants with HbA1c below 7%
Percentage of participants with HbA1c below 7%
Time frame: 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)
Time frame: Week 12 and 26
Change in fasting SMPG
Absolute change in fasting SMPG
Time frame: Baseline to Week 26
Change in SMPG profile
Absolute change in SMPG profile
Time frame: Baseline to Week 26
Change in fasting plasma glucose (FPG)
Absolute change in FPG
Time frame: Baseline to Week 26
Percentage of participants requiring rescue therapy
Percentage of participants requiring rescue therapy by additional antidiabetic medication
Time frame: Baseline to Week 12 and 26
Number of participants with hypoglycemia events
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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
Hacienda Perú, Peru
investigational site PHILIPPINES
Philippines, Philippines
...and 4 more locations
Number of participants with at least 1 hypoglycemia event
Time frame: 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).
Time frame: Baseline to Week 27
Change in Treatment satisfaction
Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire
Time frame: 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
Time frame: Baseline to Week 26