20 Week Bridging Study in Type II DM

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00563225

First received: November 21, 2007

Last updated: November 23, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

November 21, 2007

Last Updated Date

November 23, 2007

Start Date ^ICMJE

October 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00563225 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

20 Week Bridging Study in Type II DM

Official Title ^ICMJE

A Multicenter, Non-Comparative, Open, Phase III Study to Evaluate the Efficacy and Safety of Insulin Glargine on Subjects With Type 2 Diabetes Mellitus

Brief 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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus Type II

Intervention ^ICMJE

Drug: Insulin Glargine

Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)

Other Name: Lantus

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00563225

Other Study ID Numbers ^ICMJE

HOE901_3506

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Choe Seong Choon

Sanofi

Information Provided By

Sanofi

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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