Diabetes
Conditions
Brief summary
Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives: * Assess effectiveness in achieving glycemic goal measured by HbA1c; * Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; * Assess requirement for intensification of therapy by additional antidiabetics. * Assess incidence of hypoglycemia; * Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); * Assess change in body weight.
Detailed description
Patients will be observed for one year
Interventions
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Signed patient informed consent; * Type 2 diabetes mellitus; * Treated with at least 1 oral antidiabetic drug (OAD) for at least 6 months; * Hemoglobin A1c (HbA1c) \>7.0 % and ≤11% within 3 months of study baseline; * Physicians' decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen
Exclusion criteria
* Diabetes mellitus other than type 2; * Contraindication to insulin glargine U300 according to local product labelling; 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 HbA1c at month 6 | Baseline, month 6 | Percentage of patients achieving Hemoglobin A1c \<7.0%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events | Baseline to month 12 | Number of participants with Serious Adverse Events |
| Body weight | Baseline to month 12 | Change in average body weight |
| Change in HbA1c | Baseline, months 3, 6, 12 | Change from baseline in HbA1c at 3, 6, and 12 months |
| Adverse events | Baseline to month 12 | Number of participants with Adverse Events |
| Change in Self-Monitored Plasma Glucose | Baseline, months 3, 6, 12 | Change from baseline in Self-Monitored Plasma Glucose at 3, 6, and 12 months |
| Hypoglycemia | Baseline to month 12 | Number of participants with symptomatic hypoglycemic events |
| Change in fasting plasma glucose | Baseline, months 3, 6, 12 | Change from baseline in Fasting Plasma Glucose at 3, 6, and 12 months |
Countries
Colombia, Egypt, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Mexico, Peru, Philippines, Russia, Saudi Arabia, Singapore, Taiwan, Thailand, Ukraine, United Arab Emirates
Outcome results
None listed