Completed
PHASE4
INTERVENTIONAL
NCT01127269
Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Primary Objective: Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months Secondary Objectives: * Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months * Insulin glargine dose at 3 and 6 months * Hypoglycemic episodes (all types)
Interventions
Name:
INSULIN GLARGINE
Type:
DRUG
Description:
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
Primary Outcomes
Measure:
Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.
TimeFrame:
From week 0 (baseline) to week 24 (end of study)
Description:
Trial Information
NCT ID
NCT01127269
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Sanofi
Last Updated
December 15, 2025