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Continuous Glucose Monitoring System (CGMS) in Type 2 Diabetic Patients Inadequately Controlled by Metformine Monotherapy; Analyze of Glycemic Profile Before and After Association of Glimepiride

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00633425
Enrollment
43
Registered
2008-03-12
Start date
2002-10-31
Completion date
2003-10-31
Last updated
2008-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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
Lead SponsorINDUSTRY

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

MeasureTime 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

MeasureTime 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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026