Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To assess the mean change in HbA1c (glycated haemoglobin). Secondary Objectives: To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of: * Targeted HbA1c; * Targeted fasting self- monitoring blood glucose (SMBG); * Hypoglycemic events; * Adverse events; * Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change); * Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.
Detailed description
The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).
Interventions
Pharmaceutical form: pen for injection Route of administration: subcutaneous
DRUGmetformin
Pharmaceutical form: tablet Route of administration: oral
DRUGsulfonylurea
Pharmaceutical form: tablet Route of administration: oral
DRUGmeglitinides
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: pen for injection Route of administration: subcutaneous
DRUGDipeptidyl peptidase-IV (DPP-IV) inhibitors
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
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
: * Adult patients with type 2 diabetes mellitus (≥18 years of age). * Type 2 diabetes mellitus diagnosis ≥1 year. * Treated with ≥1 oral antidiabetics (±glucagon like peptid-1 (GLP-1) analogue) without insulin, for at least 6 months and HbA1c level between 8-11% (insulin-naïve). * Stable antidiabetic treatment for at least 3 months. * Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose \[SMBG\]). * Signed informed consent obtained.
Exclusion criteria
* Age \<18 years old. * Type 1 diabetes mellitus. * Having secondary type 2 diabetes mellitus. * Use of any insulin therapy including premix, basal plus/basal bolus regimen from the diagnosis. * History of hypoglycemia unawareness. * Known hypersensitivity/intolerance to insulin glargine or any of its excipients. * Have any condition (including known substance or alcohol abuse or psychiatric disorder) that precludes the patient from following and completing the study protocol. * Use of systemic glucocorticoids for two weeks or more within 12 weeks prior to the time of screening. * Pregnant or lactating women. * Participation in another clinical trial. 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 |
|---|---|
| Mean change from baseline in HbA1c | Baseline, Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients reaching targeted fasting SMBG (80-130 mg/dL) | At Weeks 12 and 24 |
| Duration to reach target pre-breakfast SMBG | Baseline, Week 24 |
| Mean change from baseline in HbA1c | Baseline, Week 12 |
| Percentage of patients achieving targeted fasting self-monitored blood glucose (SMBG) without experiencing severe and/or confirmed hypoglycemia ≤70mg/dL and <54 mg/dL | At Weeks 12 and 24 |
| Mean change from baseline in fasting plasma glucose (FPG) | Baseline, Weeks 12, and 24 |
| Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores | Baseline, Week 24 |
| Mean change from baseline in SMBG | Baseline, Weeks 12, and 24 |
Countries
Turkey (Türkiye)
Outcome results
None listed