20 Week Bridging Study in Type II DM

Diabetes Mellitus Type II Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00563225
• Other study ID #: HOE901_3506
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2007
• Last updated: November 23, 2007
• Start date: October 2002
• Est. completion date: April 2004

Study information

• Verified date: November 2007
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine
Insulin glargine at the discretion of the investigator Subcutaneous, once daily injection (at bedtime)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.
Secondary	To evaluate the efficacy of Insulin glargine (injection at bedtime, once a day) on the changes of FPG.