drugset / Trial / NCT00627471

Type 2 Diabetes Management With Lantus® (Malbec: Manejo Con Lantus® de Diabéticos Tipo 2)

NCT00627471 ↗

Phase 4 Terminated 9 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

Summary

To compare in terms of HbA1c insulin naive patients with Type 2 Diabetes starting with insulin glargine on an algorithm with insulin naive patients starting with insulin glargine on the physician's standard practice. To compare in terms of FBG insulin naïve patients starting with insulin glargine on an algorithm with insulin naïve patients starting with insulin glargine on the physician's standard practice. To compare the percentage of patients achieving HbA1c\< 7% in each treatment group. To compare hypoglycaemic events (minor, severe and nocturnal) between groups. To compare average insulin dose between groups. To compare PRO (patients' reported outcomes) between groups. To compare mean changes in body weight between treatment groups.

Timeline

Start
2008-01
Primary completion
2009-03
Completion
—

Outcome

Outcome not reported

Stopped (Enrollment): “Low recruitment in spite of strategies implemented”

Drugs

EvaluationDrugModalityDoseRoute
Comparator insulin glargine Protein / enzyme biologic — —