20 Week Bridging Study in Type II DM
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus Type II
Intervention: Insulin Glargine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s):
Choe Seong Choon, Study Director, Affiliation: Sanofi
Summary
A multicenter, non-comparative, one arm, open, phase III study to evaluate the efficacy and
safety of insulin glargine on subjects with Type 2 Diabetes Mellitus
Clinical Details
Official title: A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.
Secondary outcome: To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 2 Diabetes Mellitus diagnosed at least 3 years ago
- Treated concomitantly with insulin once a day and SU over at least 3 months prior to
study entry
- Treated with OHA monotherapy over at least 1 year
- HbA1c greater than or equal to 7. 5% and less than or equal to 12. 0%, at visit 1
(screening visit)
- BMI < 40 kg/m2
- No history of ketonemia
- Women of childbearing potential using the medically approved contraceptive method
- Ability and willingness to perform blood glucose monitoring using a blood glucose
meter as per the requirement of protocol
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Locations and Contacts
Additional Information
Starting date: October 2002
Last updated: November 23, 2007
|
