Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: \>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c \<= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: * Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. * Incidence of confirmed symptomatic and nocturnal hypoglycemia. * Incidence of confirmed severe hypoglycemia (\< 36mg/dL or need of help to recover). \>Weight variation for each period of treatment. * Creatinine clearance at baseline and after each period of treatment. * Overall safety: Incidence of adverse events.
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
DRUGNPH insulin (insulin isophane)
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
DRUGINSULIN GLULISINE
Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
DRUGRegular insulin
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
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
* Type 2 diabetes and renal failure in use of NPH regular insulin or fast-acting analog and HbA1c \>= 8%. * Albuminuria or microalbuminuria diabetic retinopathy. * Creatinine clearance \< 60 mL/min/1,73 m2 and \>30 mL/min/1,73 m2
Exclusion criteria
* Hypersensibility to insulin glargine or any other component of the insulin formulation. * Use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months. * History of diabetic ketoacidosis or positive GAD antibodies. * Advanced retinopathy needing laser therapy. * Diagnosed advanced neuropathy * Severe hepatic disease or active hepatitis. * Cardiac failure class III or IV (NYHA). * Patients on hemodialysis. * Diagnosed cancer. * Active infection. * Current therapy with steroids. * Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism. 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 |
|---|---|
| Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%. | From visit 1 (Day 1) to visit 13 (Day 169) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL). | From baseline and Visit 13 (Day 169) |
| Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL. | From baseline and Visit 13 (Day 169) |
| Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration | From baseline and Visit 13 (Day 169) |
| Weight variation | From baseline to the end of treatment at visit 13 (day 169) |
| Creatinine clearance variation | From baseline to the end of treatment at visit 13 (day 169) |
Countries
Brazil
Outcome results
None listed