Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition

Phase 4

Terminated

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

• Registration Number: NCT01081938
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

1- Proportion of patients with mean daily glycemia \<140mg/dL during the period of 7 days of treatment with glargine plus supplemental glulisine versus patients with glulisine sliding scale.

Secondary Objective:

1. Incidence of moderate hyperglycemia (\>140mg/dL) during the treatment period.

2. Incidence of hypoglycemia (\<60mg/dL and \< 40mg/dL) during the treatment period.

3. Incidence of severe hyperglycemia (\>400mg/dL) during the treatment period.

4. Total dose of insulin and correction dose in each group.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-03-04
• Study First Posted: 2010-03-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-26
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	INSULIN GLARGINE	Insulin Glargine + Insulin Glulisine
1	INSULIN GLULISINE	Insulin Glargine + Insulin Glulisine
2	INSULIN GLULISINE	Insulin Glulisine

Primary Outcome Measures

Name	Time	Method
Glycaemic parameters assessment	During the period of 7 Days of treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of moderate and severe hyperglycemia	During the period of 7 Days of treatment
Incidence of symptomatic, nocturnal and severe hypoglycemias	During the period of 7 Days of treatment

Trial Locations

Locations (10)

Sanofi-Aventis Investigational Site Number 076-007; 🇧🇷 Belo Horizonte, Brazil

Sanofi-Aventis Investigational Site Number 076-004; 🇧🇷 Porto Alegre, Brazil

Sanofi-Aventis Investigational Site Number 076-006; 🇧🇷 São José do Rio Preto, Brazil

Sanofi-Aventis Investigational Site Number 076-003; 🇧🇷 São Paulo, Brazil

Sanofi-Aventis Investigational Site Number 076-009; 🇧🇷 São Paulo, Brazil

Sanofi-Aventis Investigational Site Number 076-005; 🇧🇷 Joinville, Brazil

Sanofi-Aventis Investigational Site Number 076-010; 🇧🇷 São Paulo, Brazil

Sanofi-Aventis Investigational Site Number 076-011; 🇧🇷 Curitiba, Brazil

Sanofi-Aventis Investigational Site Number 076-001; 🇧🇷 Porto Alegre, Brazil

Sanofi-Aventis Investigational Site Number 076-008; 🇧🇷 São Paulo, Brazil