Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone

Sanofi1 site in 1 country396 target enrollmentJuly 2004

Overview

Brief Summary

Primary objective:

The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.

Secondary objective:

Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:

Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)
Change of fasting plasma glucose (baseline to endpoint)
Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint
Insulin dose (rapid-acting, basal and total daily doses)
Weight, body-mass index
Hypoglycemic events
Adverse events

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

September 2006

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change in HbA1c.

Time Frame: from baseline to study endpoint.

Secondary Outcomes

Change of pre-, 2 h postprandial and nocturnal blood glucose values(8-point profile)
Fasting blood glucose(8-point blood glucose profile values)
Responder rate HbA1c smaller 7 %(at study endpoint)
Insulin dose(rapid-acting, basal and total daily doses)
Weight, BMI(study follow-up)
Hypoglycemic events(study follow-up)
Adverse events.(study follow-up)