Diabetes Mellitus
Conditions
Brief summary
The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.
Interventions
DRUGINSULIN GLARGINE
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.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evolution of efficacy parameters between first study visit (V1) and last study visit (V5) | Mean time interval: 10 months |
Countries
Belgium
Outcome results
None listed