Type 2 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To test the hypothesis that basal insulin based treatment (G+) is noninferior to twice-daily premixed insulin (PM-2) in term of hemoglobin A1c (glycosylated hemoglobin, HbA1c) reduction from baseline to end of study. The test for superiority can be done if noninferiority is achieved. Secondary Objectives: * To assess efficacy in terms of percentage of patients achieving HbA1c \<7% and HbA1c \<7% without hypoglycemia. * To assess efficacy in terms of percentage of patients achieving fasting plasma glucose (FPG) \<7 mmol/L and FPG \<7 mmol/L without hypoglycemia. * To assess safety in term of occurrence of moderate/severe hypoglycemia. * To assess daily blood glucose (BG) variation. * To assess patient satisfaction.
Detailed description
The duration of study is approximately 21 months. Each patient will be followed for approximately 27 weeks from screening visit to end-of-study
Interventions
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
DRUGInsulin Glulisine
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
DRUGBiphasic insulin aspart 30
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
DRUGRepaglinide
Pharmaceutical form: tablet Route of administration: oral administration
DRUGAcarbose
Pharmaceutical form: tablet Route of administration: oral administration
DRUGMetformin
Pharmaceutical form: tablet 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
: * Patients with age between 18 and 70 years. * Hemoglobin A1c\>7.5%, and ≤11%. * Fasting plasma glucose \>7 mmol/L. * Fasting C peptide \>1 ng/mL. * Type 2 diabetes (T2DM) patients with diabetes diagnosis between 2 and 10 years (World Health Organization 1999 T2DM diagnose criteria). * Continuous treatment with stable doses of metformin (≥1 g/day) and 1 oral antihyperglycemic drug (at least half maximum dose) for more than 3 months prior to screening. * Body mass index ≥21 kg/m2, and \<40 kg/m2.
Exclusion criteria
* More than 7 consecutive days of insulin treatment within the 12 months except for acute disease or surgery. * Diabetes other than T2DM (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake). * History of hypoglycemia unawareness or recurrent hypoglycemia or severe hypoglycemia within the past 12 months. * History of sensitivity to the study drugs or to drugs with a similar chemical structure. * 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) within the past 12 months. * Significant diabetic complications and serious disease, e.g., symptomatic autonomic neuropathy, gastroparesis, unstable angina or active proliferative retinopathy. * Acute infections which may affect BG control within the past 4 weeks. * Active liver disease, alanine transaminase (ALT) and/or aspartate aminotransferase (AST) greater than two times the upper limit of the reference range at screening. * 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). 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 hemoglobin A1c (HbA1c) | Baseline to Week 24 | Change in HbA1c from baseline to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients with FPG <6.1 mmol/L without hypoglycemia | At Week 12 and Week 24 | Percentage of patients with FPG \<6.1 mmol/L without hypoglycemia at week 12 and week 24 |
| Patients with FPG <7 mmol/L | At Week 12 and Week 24 | Percentage of patients with FPG \<7 mmol/L at week 12 and week 2 |
| Patients with FPG <7 mmol/L without hypoglycemia | At Week 12 and Week 24 | Percentage of patients with FPG \<7 mmol/L without hypoglycemia at week 12 and week 24 |
| Patients with HbA1c <7% | At Week 12 and Week 24 | Percentage of patients with HbA1c \<7% at week 12 and week 24 |
| Patients with HbA1c <7% without hypoglycemia | At Week 12 and Week 24 | Percentage of patients with HbA1c \<7% without hypoglycemia at week 12 and week 24 |
| Hypoglycemic events | Baseline to Week 24 | Incidence of hypoglycemia during treatment period |
| Patients with fasting plasma glucose (FPG) <6.1 mmol/L | At Week 12 and Week 24 | Percentage of patients with FPG \<6.1 mmol/L at week 12 and week 24 |
| Change in body weight | Baseline to Week 24 | Change in body weight from baseline to week 24 |
| Insulin dose | At Week 24 | Total daily insulin dose at week 24 |
| Daily BG variation at week 24 | At Week 24 | Daily blood glucose (BG) variation at week 24 |
| European quality of life - 5 dimensions (EQ-5D) | Baseline to Week 24 | Change in quality of life scores from baseline to week 24 on 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is measured at 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problem. |
| Subgroup analysis | At week 24 | Subgroup analysis of control rate of HbA1c \<7% according to duration of diabetes, oral anti-hyperglycemic drug(OAD) treatment and HbA1c at screening, FPG, post prandial glucose(PPG) excursion and C peptide at the beginning of run-in period, insulin dose at end of run-in period |
| Change in FPG | Baseline to Week 24 | Change in FPG from baseline to week 24 |
Countries
China
Outcome results
None listed