Extension to Study HMR1964A/3011 in Belgium

Sanofi32 enrolled

Overview

The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

INSULIN GLARGINEDRUG

The subjects will continue the treatment with HOE 901 in the same way as they have done in the previous study. Based on the investigator's assessment and the approved SPC in Belgium/Luxembourg, the dosage can be adjusted individually. HOE 901 is to be injected once daily. HOE 901 must not be mixed with any other insulin, including regular human insulin or fast-acting insulin analogues.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects treated with HOE901 and who, in the judgement of the investigator, have benefited from the use of HOE 901 in a previous clinical study with HOE 901. * Subjects treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism. * Subjects who are likely to comply with the investigator's instructions. Exclusion Criteria: * Evidence of an uncooperative attitude. * Subject not on adequate contraception, or who is pregnant, or breast feeding. * Subject unable to understand informed consent. * Patient receiving or likely to receive HOE901 treatment outside of SPC or PI recommendations. * Subject becomes pregnant or is planning to become pregnant.

Locations (1)

Sanofi-Aventis

Brussels, Belgium

Outcomes

Primary Outcomes

Evolution of efficacy parameters between first study visit (V1) and last study visit (V5)

Time frame: Mean time interval: 10 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.