Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: -To test the hypothesis that higher initial dose of basal insulin (0.3 U/kg) is non inferior to standard initial dose (0.2 U/kg) based on the percentage of patients with at least one episode of hypoglycemia (≤3.9 mmol/L or severe) during the 16 weeks of treatment in overweight and obese type 2 diabetic patients uncontrolled with oral anti-diabetes drugs (OADs). Secondary Objective: * To evaluate the percentage of patients achieving glycated hemoglobin (HbA1c) \<7%. * To evaluate the percentage and accumulated percentage of patients achieving fasting plasma glucose (FPG) target (\<5.6, \<6.1, and \<7.0 mmol/L). * To assess the changes in HbA1c, FPG, and postprandial glucose (PPG). * To evaluate the insulin doses change. * To evaluate the weight change. * To evaluate overall hypoglycemia, nocturnal hypoglycemia and severe hypoglycemia occurrence. * To descriptively evaluate the safety profile. * To assess patient and physician satisfaction and adherence (drop-out rate and the percentage of patients who can follow the treatment and insulin titration). * Subgroup analysis on efficacy (control rate, control rate without confirmed hypoglycemia, and changes in HbA1c, FPG and PPG) and safety data according to: * Age * Duration of diabetes * Baseline treatment (OAD) * Baseline HbA1c, FPG and PP
Detailed description
The duration of study for each patient is approximately 20 weeks from screening visit to end-of-study follow-up phone call.
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form: solution Route of administration: subcutaneous injection
DRUGmetformin
Pharmaceutical form: table or capsule Route of administration: oral administration
DRUGacarbose
Pharmaceutical form: table or capsule Route of administration: oral administration
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
: * Age ≥ 18 and ≤ 70 years. * Type 2 diabetes patients with diabetes diagnosis at least 2 years. * Continuous treatment with stable doses of 2-3 OADs, for more than three months prior to randomization, among which metformin ≥1.5 g/day or at maximum tolerated dose * HbA1c \>7.5% and ≤11%. * FPG \>9 mmol/L. * BMI ≥25 and ≤40 kg/m\^2. * Ability and willingness to perform self-monitoring of blood glucose using the Sponsor-provided glucose meter and to complete the patient diary. * Willingness and ability to comply with the study protocol. * Signed informed consent obtained prior any study procedure.
Exclusion criteria
* Known hypersensitivity/intolerance to insulin glargine or any of its excipients. * History of hypoglycemia unawareness. * Unexplained hypoglycemia in the past 6 months. * Pregnancy or planned pregnancy or current lactation (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method). * Acute diabetic complications (diabetic ketoacidosis, lactic acidosis, hyperosmolar nonketotic diabetic coma). * History of stroke, myocardial infarction, angina pectoris, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within the previous 12 months. * Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination or disease history record, in the 2 years prior to study entry. * Impaired renal function defined as, but not limited to, serum creatinine levels ≥1.5 mg/dL (132 μmol/L) for males and ≥1.4 mg/dL (123 μmol/L) for females or presence of macroproteinuria (\>2 g/day). * Active liver disease (alanine transaminase \[ALT\] greater than two times the upper limit of the reference range, as defined by the local laboratory). 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 |
|---|---|
| Percentage of patients with at least one episode of hypoglycemia | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L) | 16 weeks |
| Accumulated percentage of patients achieving Fasting Plasma Glucose target (<5.6, <6.1, and <7.0 mmol/L) | 16 weeks |
| Change from baseline in HbA1c | Baseline, 16 weeks |
| Change from baseline in Fasting Plasma Glucose | Baseline, 16 weeks |
| Change from baseline in Post Prandial Glucose | Baseline, 16 weeks |
| Percentage of patients achieving HbA1c <7% | 16 weeks |
| - Change in insulin dose | Baseline, 16 weeks |
| Number of overall hypoglycemic events (with severe or confirmed hypoglycemia [≤3.9 mmol/L]) | Baseline, 16 weeks |
| Number of nocturnal hypoglycemic events | Baseline, 16 weeks |
| Number of severe hypoglycemic events | Baseline, 16 weeks |
| Change in body weight | Baseline, 16 weeks |
Countries
China
Outcome results
None listed