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.

PHASE4CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

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

DRUG

NPH insulin (insulin isophane)

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

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

DRUG

Regular insulin

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

Trial Locations (10)

72155000

Investigational Site Number 076-006, Taguatinga

80060-900

Investigational Site Number 076-007, Curitiba

60015-052

Investigational Site Number 076-010, Fortaleza

60115-282

Investigational Site Number 076-001, Fortaleza

91350-250

Investigational Site Number 076-003, Porto Alegre

01244-030

Investigational Site Number 076-005, São Paulo

01308-050

Investigational Site Number 076-013, São Paulo

01323-001

Investigational Site Number 076-004, São Paulo

04024-002

Investigational Site Number 076-002, São Paulo

o4039-000

Investigational Site Number 076-009, São Paulo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY