NCT00633425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

First QC Date

March 4, 2008

Last Update Submit

March 26, 2008

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • HbA1c and fasting blood glucose levels.

    Measured in the observation and maintenance phases, and change between the two phases.

Interventions

GLIMEPIRIDEDRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

glimepiride

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nathalie Billon

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

October 1, 2002

Study Completion

October 1, 2003

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

FR(1)