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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Glimepiride (HOE490); Drug: placebo; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00924573

HOE490/4045

EFC10846

Details and patient eligibility

About

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

Full 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.

Enrollment: 189 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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189 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: Glimepiride (HOE490)

Drug: Metformin

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Glimepiride (HOE490)

Drug: placebo