Phase 3
Completed N=1,160
Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01368081 ↗Enrolled (actual)
1,160
Serious AEs
6.6%
Results posted
Jun 2014
Primary outcomePrimary: Number of Patients With Drug Related Adverse Events — 19; 25; 13; 13 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Drug Related Adverse Events |
19; 25; 13; 13; 9; 20 | — |
| SECONDARY Change From Baseline in HbA1c |
-0.93; -0.96; -0.97; -0.81; -0.98; -0.90 | — |
Eligibility Criteria
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 = 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)
Data sourced from ClinicalTrials.gov (NCT01368081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.