Comparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Double-blinded Comparative Study to Investigate the Efficacy and Safety of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride in Patients With T2DM Inadequately Treated With Constant Dose of Glimepiride

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924573
• Other study ID #: EFC10846
• Secondary ID: HOE490/4045
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2009
• Last updated: August 30, 2011
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: August 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Primary objective of this study is to confirm the efficacy of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride in HbA1c change.

Secondary objectives of this study is to evaluate the safety of HOE490 O (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters

Description:

Patients treated with 2-6mg/day of glimepiride will be recruited. The study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus patients treated with constant dose of glimepiride on top of diet and exercise

• Patients who gave informed consent to participate in the study

Exclusion Criteria:

• Patients with HbA1c of < 7.0 % and > 11.0 %

• Patients with any following laboratory test abnormality :

• ALT and/or AST: > 3 X ULN

• Neutrophils: < 1,000/mm3 and/or platelets < 100,000/mm3

• Hemoglobin: <11 g/dL

• Creatinine: >= 1.3 mg/dL in case of male or >= 1.0 mg/dL in case of female

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Metformin
oral administration
• placebo
oral administration
• Glimepiride (HOE490)
oral administration

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c from baseline		24 weeks	No
Secondary	Change in the ratio patients with < 7.0% of HbA1c		24 weeks	No