Type 2 Diabetes Mellitus
Conditions
Brief summary
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)
Detailed description
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.
Interventions
Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Participants with Type 2 diabetes mellitus * Participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin,sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening. * HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.
Exclusion criteria
* History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit. * Proliferative retinopathy or maculopathy requiring treatment according to the Investigator * Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted). * Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with Treatment Emergent Adverse Events (TEAEs) | Baseline to Week 24 | TEAEs including serious adverse events (SAEs) and hypoglycemic episode |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Percentage of participants with at least one confirmed hypoglycemia event | 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 | 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) |
| Change in 7-point SMBG profile from Baseline to Week 24 | Baseline to Week 24 | — |
Countries
India
Outcome results
None listed