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

Overview[ - collapse ][ - ]

Purpose 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
ConditionType 2 Diabetes Mellitus
InterventionDrug: Metformin
Drug: placebo
Drug: Glimepiride (HOE490)
PhasePhase 3
SponsorSanofi
Responsible PartySanofi
ClinicalTrials.gov IdentifierNCT00924573
First ReceivedJune 18, 2009
Last UpdatedAugust 30, 2011
Last verifiedAugust 2011

Tracking Information[ + expand ][ + ]

First Received DateJune 18, 2009
Last Updated DateAugust 30, 2011
Start DateMay 2009
Estimated Primary Completion DateMarch 2010
Current Primary Outcome MeasuresChanges in HbA1c from baseline [Time Frame: 24 weeks] [Designated as safety issue: No]
Current Secondary Outcome MeasuresChange in the ratio patients with < 7.0% of HbA1c [Time Frame: 24 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleComparative Study of HOE490 O (Glimepiride and Metformin) Compared With Placebo on Top of Glimepiride
Official TitleDouble-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
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.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Metformin
oral administration
Drug: placebo
oral administration
Drug: Glimepiride (HOE490)
oral administration
Study Arm (s)
  • Experimental: 1
    Metformin on top of glimepiride
    Twice a day with 2-6 mg of daily dose for glimepiride and 500-750mg of daily dose for metformin for 24 weeks
  • Placebo Comparator: 2
    Placebo on top of glimepiride
    Twice a day with 2-6 mg of daily dose for glimepiride and 2-3 tablets of placebo for 24 weeks

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment189
Estimated Completion DateMarch 2010
Estimated Primary Completion DateMarch 2010
Eligibility Criteria
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.
GenderBoth
Ages20 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesJapan

Administrative Information[ + expand ][ + ]

NCT Number NCT00924573
Other Study ID NumbersEFC10846
Has Data Monitoring CommitteeNo
Information Provided BySanofi
Study SponsorSanofi
CollaboratorsNot Provided
Investigators Principal Investigator: Kaku Kohei, Professor Kawasaki Medical University
Verification DateAugust 2011

Locations[ + expand ][ + ]

Sanofi-Aventis Administrative Office
Tokyo, Japan