Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen. Secondary Objective: To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
DRUGINSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
DRUGInsulin aspart
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months: * Sub-optimal: HbA1c level \>7% and fasting blood glucose \<130mg/dL 2. Male or Female ≥18 years old 3. Body Mass Index (BMI) \<40 4. 10% ≥HbA1c ≥7% 5. If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months 6. Patients willing to sign data release consent form
Exclusion criteria
1. Diabetes other than T2DM 2. Enrolled in other clinical trials 3. Previous treatment with an insulin other than insulin glargine 4. Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists or with Di Peptidyl Peptidase 4 (DPP-IV) inhibitors 5. Pregnant or lactating women 6. Contraindicated to Lantus (insulin glargine) / Apidra (insulin glulisine) / Novomix 30 (insulin aspart) 7. Treatment with systemic corticoid steroids within the last 3 months prior to study enter 8. Treatment with any investigational product within the last 3 months prior to study entry 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 |
|---|---|
| Change in hemoglobin A1c level (HbA1c) | At 6 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with HbA1c < 7% | from baseline to the study endpoint (over 6 months of treatment) |
| Change in body weight | from baseline to the study endpoint (over 6 months of treatment) |
| Rate of hypoglycemic events (total, severe, nocturnal) | from baseline to the study endpoint (over 6 months of treatment) |
| Change in Quality of Life | from baseline to the study endpoint (over 6 months of treatment) |
| Continuous Glucose Monitoring System (CGMS) data | at baseline, 3 and 6 months |
| Reactive Oxidative Stress (ROS) level changes | from baseline to the study endpoint (over 6 months of treatment) |
Countries
South Korea
Outcome results
None listed