Primary Objective: To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs Secondary Objective: To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)
The maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
228
Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous
Investigational site Number 3560003
Jaipur, India
Investigational site Number 3560013
Nashik, India
Percentage of participants with Treatment Emergent Adverse Events (TEAEs)
TEAEs including serious adverse events (SAEs) and hypoglycemic episode
Time frame: Baseline to Week 24
Percentage of participants with at least one confirmed hypoglycemia event
Time frame: Baseline to Week 24
Change in HbA1c from Baseline to week 12 and week 24
Time frame: Baseline to Week 12 and Week 24
Percentage of participants reaching HbA1c target of <7%
Time frame: 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)
Time frame: Week 12 and Week 24
Change in fasting plasma glucose (FPG) from Baseline to Week 24
Time frame: Baseline to Week 24
Change in fasting SMBG from Baseline to Week 24
Time frame: Baseline to Week 24
Change in 7-point SMBG profile from Baseline to Week 24
Time frame: Baseline to Week 24
Percentage of participants requiring rescue therapy
Time frame: Week 12 and Week 24
Change in body weight from Baseline to Week 12 and Week 24
Time frame: Baseline to Week 12 and Week 24
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Change in insulin dose from Baseline to Week 12 and Week 24
Time frame: 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)
Time frame: Baseline to Week 12 and Week 24