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. (DINAMO)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: INSULIN GLULISINE; Drug: INSULIN GLARGINE; Drug: Regular insulin; Drug: NPH insulin (insulin isophane)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01122979

LANTU_L_04737

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

group 1: insulin glargine + insulin glulisine

Experimental group

Description:

insulin glargine once daily + glulisine at meal times

Treatment:

Drug: INSULIN GLULISINE

Drug: INSULIN GLARGINE

group 2 NPH insulin + regular insulin

Active Comparator group

Description:

NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times

Treatment:

Drug: Regular insulin

Drug: NPH insulin (insulin isophane)