Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs — CHANGING  

Diabetes Mellitus, Type 2 Clinical Trial

Official title: Efficacy and Safety of Intensive Insulin Therapy With Insulin Glulisine in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs

Status Completed

Clinical Trial Summary

Primary Objective:

To evaluate the efficacy of an intensive insulin regimen with insulin glargine and insulin glulisine in terms of change in Hemoglobin A1c (HbA1c) level from week 12 (visit 7) to week 24 (visit 10).

Secondary Objectives:

1. Percentage of patients with HbA1c < 7% at week 24.

2. Percentage of patients with HbA1c < 7% and no symptomatic nocturnal hypoglycemia event at week 24.

3. Fasting Plasma Glucose (FPG) and 7-point Self Monitoring of Blood Glucose (SMBG) at week 0, week 12 and week 24.

4. Doses of insulin glargine and insulin glulisine: the daily dose (U) and the daily dose / kg (U/kg) will be calculated at week 24.

5. Systolic and diastolic blood pressure, heart rate, weight change will be measured at week 0, week 12 and week 24.

6. Number of patients suffering hypoglycemias (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe) will be evaluated during the treatment period. 7-Adverse events.

Clinical Trial Description

The study is divided in 3 periods:

1. a 2-week run-in period,

2. a 12-week treatment period 1

3. a 12-week treatment period 2 study treatment duration per patient: 24 weeks study duration per patient: 26 weeks ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

• NCT number: NCT01203111
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: December 2010
• Completion date: July 2012