Diabetes Mellitus, Type 2 Clinical Trial
Official title:
National (Brazil), Phase IV, Multicentric, Open Label, Parallel, Comparative Study of the Use of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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