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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00924573
Enrollment
189
Registered
2009-06-19
Start date
2009-05-31
Completion date
2010-03-31
Last updated
2011-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Glimepiride, Metformin, Combination Drug Therapy

Brief 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

Detailed 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.

Interventions

DRUGMetformin

oral administration

DRUGplacebo

oral administration

DRUGGlimepiride (HOE490)

oral administration

Sponsors

Sanofi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Changes in HbA1c from baseline24 weeks

Secondary

MeasureTime frame
Change in the ratio patients with < 7.0% of HbA1c24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026