Insulin Glulisine in Diabetes Mellitus, Type 2

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Therapy; Drug: Insulin Glulisine; Drug: Insulin Glargine

• Registration Number: NCT00174668
• Lead Sponsor: Sanofi

Brief Summary

Primary objective:

The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint.

Secondary objectives:

Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2007-11
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Insulin Therapy	Two daily injection conventional insulin therapy
1	Insulin Glulisine	Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously
1	Insulin Glargine	Mealtime insulin glulisine 3x daily and insulin glargine 1 x daily subcutaneously

Primary Outcome Measures

Name	Time	Method
HbA1c	From baseline to study endpoint
Self monitored BG (SMBG) values	During the whole treatment phase
Body weight/body mass index (BMI)	From baseline to study endpoint and all other visits
Fasting blood lipid profile	From baseline to study endpoint and all other visits
Urine albumin	From baseline to study endpoint and all other visits
Total daily insulin dose	From baseline to study endpoint

Secondary Outcome Measures

Name	Time	Method
Adverse events	Throughout the study,
Standard laboratory tests	From baseline to study endpoint and all other visits
Vital signs	From baseline to study endpoint and all other visits
Physical examination	From baseline to study endpoint and all other visits

Trial Locations

Locations (2)

Sanofi-aventis; 🇷🇴 Bucharest, Romania

Sanofi-Aventis; 🇬🇧 Guildford, United Kingdom