Diabetes Mellitus
Conditions
Brief summary
Analyse the glucose profile, based on continuous glucose monitoring by CGMS, in type 2 diabetics inadequately controlled by metformin, before and after the addition of Glimepiride.
Interventions
DRUGGLIMEPIRIDE
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Men or women aged 35 to 70 years * Having given their consent * Type 2 diabetics (HBA1c greater than 6.5% * Fasting glycaemia greater than 1.40 g/l) not controlled by Metformin for at least 6 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in interstitial glucose levels between the observation and maintenance phases. | The mean of 24 variations in average hourly glucose readings recorded by CGMS. |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c and fasting blood glucose levels. | Measured in the observation and maintenance phases, and change between the two phases. |
Countries
France
Outcome results
None listed