Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Metformin; Drug: Placebo (low dose); Drug: BI 10773; Drug: Placebo (high dose)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368081

1245.52

Details and patient eligibility

About

The objective of the study is to investigate the long-term safety and efficacy of BI 10773 given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2 diabetes mellitus with insufficient glycaemic control.

Enrollment: 1,162 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• .Diagnosis of type 2 diabetes mellitus prior to informed consent
• Male and female patients, on diet and exercise regimen, who are pre-treated with one of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide, Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or thiazolidinedione
• glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national glycohemoglobin standardization program)

Exclusion criteria

• Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)
• Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
• Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,162 participants in 3 patient groups

BI 10773 low dose

Experimental group

Description:

BI 10773 low dose tablet once daily

Treatment:

Drug: BI 10773

Drug: Placebo (high dose)

Drug: BI 10773

BI 10773 high dose

Experimental group

Description:

BI 10773 high dose tablet once daily

Treatment:

Drug: BI 10773

Drug: Placebo (low dose)

Drug: BI 10773

Metformin

Active Comparator group

Description:

Metformin tablets 500-2250 mg a day (twice or three times per day)

Treatment:

Drug: Metformin