LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322075

LANTU_L_00722

EudraCT # : 2006-000122-31

Details and patient eligibility

About

Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year

Exclusion criteria

• Diabetic ketoacidosis
• Any other severe disease
• Pregnancy or fertile female without contraception
• Alcohol/drug abuse, selected prohibited concomitant medication
• Nightshift work

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)