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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

• Registration Number: NCT01203111
• Lead Sponsor: Sanofi

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Study Start: 2010-12
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-29
• Last Update Posted: 2012-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive insulin regimen	INSULIN GLARGINE	Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1)
Intensive insulin regimen	INSULIN GLULISINE	Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥7% at week 12 (end of treatment period 1)
insulin regimen	INSULIN GLARGINE	Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: no change, if HbA1c \<7% at week 12 (end of treatment period 1)

Primary Outcome Measures

Name	Time	Method
Change in HbA1c level for patients with addition of glulisine at week 12	between week 12 and week 24 (end of treatment period)

Secondary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose	at week 0, week 12 and week 24
Percentage of patients with HbA1c level < 7%	at week 24 (end of treatment period)
Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event	at week 24 (end of treatment period)
7-point Self Monitoring of Blood Glucose	at week 0, week 12 and week 24
Daily dose of insulin glargine	at week 24 (end of treatment period)
Daily dose of insulin glulisine	at week 24 (end of treatment period)
Systolic / diastolic blood pressure, heart rate, weight change	from week 0 (baseline) to week 24 (end of treatment period)
Hypoglycemia (asymptomatic, symptomatic, nocturnal symptomatic, severe and nocturnal severe)	from week 0 (from baseline) to week 24 (end of treatment)

Trial Locations

Locations (1)

Administrative office; 🇻🇪 Caracas, Venezuela