A Prospective Study to Optimize Insulin Treatment by Basal Regimen With Insulin Glargine in Type-2-Diabetic Patients Previously Uncontrolled on Premixed Insulin

Sanofi1 site in 1 country313 target enrollmentApril 2008

ConditionsDiabetes Mellitus, Type 2

InterventionsInsulin Glargine

DrugsInsulin Glargine

Overview

Phase: Phase 4
Intervention: Insulin Glargine
Conditions: Diabetes Mellitus, Type 2
Sponsor: Sanofi
Enrollment: 313
Locations: 1
Primary Endpoint: HbA1c values
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective:

To show an improvement in HbA1c control after 4 months of treatment with insulin glargine + Oral Anti Diabetic (OAD) in patients previously uncontrolled on premixed insulin (with OAD)

Secondary objective:

Improvement of Fasting blood glucose (FPG) after 4 months treatment (% of patients treated to target HbA1c ≤7.0% and/or FBG≤6.0mmol/L). Frequency of hypoglycemic episodes, quality of life with basal+ OAD regimen.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

July 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Patients with Type 2 Diabetes Mellitus inadequately controlled at least 3 months on premixed insulin with 1 or 2 OADs
•7.5 ≤ HbA1c ≤ 9.5%
•FPG ≥6.7 mmol/L
•History of Diabetes mellitus ≤10 years
•Premix insulin daily dosage ≤ 50 IU/Day

Exclusion Criteria

•Type 1 Diabetes Mellitus
•Former treated on TZD
•Pregnancy / Lactation
•Creatine ≥1.5 mg/dl
•Hepatic disease, jaundice,or ALT/AST≥ 2.5 times of normal range
•Hormone therapy,
•Acute status of Diabetes complications
•Severe concomitant disease or complications with high risk of unexpected fatal events, like Myocardial Infarct, stroke, heart failure.
•Allergic to insulin glargine or any ingredient
•Participation in another clinical trial within 3 months