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.

NCT ID: NCT01122979

Last Updated: 2013-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group 1: insulin glargine + insulin glulisine

insulin glargine once daily + glulisine at meal times

Group Type: EXPERIMENTAL

INSULIN GLARGINE

Intervention Type: DRUG

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

INSULIN GLULISINE

Intervention Type: DRUG

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

group 2 NPH insulin + regular insulin

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

Group Type: ACTIVE_COMPARATOR

NPH insulin (insulin isophane)

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

Regular insulin

Intervention Type: DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

Interventions

INSULIN 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

Intervention Type: DRUG

NPH insulin (insulin isophane)

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

Intervention Type: DRUG

INSULIN 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

Intervention Type: DRUG

Regular insulin

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 076-007

Curitiba, , Brazil

Investigational Site Number 076-010

Fortaleza, , Brazil

Investigational Site Number 076-001

Fortaleza, , Brazil

Investigational Site Number 076-003

Porto Alegre, , Brazil

Investigational Site Number 076-005

São Paulo, , Brazil

Investigational Site Number 076-013

São Paulo, , Brazil

Investigational Site Number 076-004

São Paulo, , Brazil

Investigational Site Number 076-002

São Paulo, , Brazil

Investigational Site Number 076-009

São Paulo, , Brazil

Investigational Site Number 076-006

Taguatinga, , Brazil

Countries

Brazil

Other Identifiers

LANTU_L_04737

Identifier Type: -

Identifier Source: org_study_id