Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

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.