Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
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 on standard of care basal insulin therapy administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without other antidiabetics approved for using with insulin. * Glycated hemoglobin (HbA1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening. * Fasting plasma glucose values above 130 mg/dL.
Exclusion criteria
* Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection, insulin doses \[variation more than ±20%\]). * Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin, 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). 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 |
|---|---|---|
| Change in glycated hemoglobin (HbA1c) | Baseline to Week 26 | Absolute change in HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants with HbA1c below 7% | Week 12 and 26 | Percentage of participants with HbA1c below 7% |
| Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L) | Week 12 and 26 | Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L) |
| Change in fasting SMPG | Baseline to Week 26 | Absolute change in fasting SMPG |
| Change in SMPG profile | Baseline to Week 26 | Absolute change in SMPG profile |
| Change in fasting plasma glucose (FPG) | Baseline to Week 26 | Absolute change in FPG |
| Change in glycated hemoglobin (HbA1c) | Baseline to Week 12 | Absolute change in HbA1c |
| Number of participants with hypoglycemia events | Baseline to Week 26 | Number of participants with at least 1 hypoglycemia event |
| Number of participants with adverse events (AEs) | Baseline to Week 27 | Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness). |
| Change in Treatment satisfaction | Baseline to Week 26 | Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire |
| Number of participants with health care utilization | Baseline to Week 26 | Number of participants with health care utilization, including hospitalization, emergency room visits, and office \[or specialty\] visits |
| Percentage of participants requiring rescue therapy | Baseline to Week 12 and 26 | Percentage of participants requiring rescue therapy by additional antidiabetic medication |
Countries
Argentina, Colombia, Egypt, Hong Kong, India, Indonesia, Lebanon, Malaysia, Peru, Philippines, Saudi Arabia, South Africa, Thailand, Turkey (Türkiye)
Outcome results
None listed