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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


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.


Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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