Phase 2
N=547
Empagliflozin (BI 10773) Dose Finder Study in Japanese Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01193218 ↗Enrolled (actual)
547
Serious AEs
3.2%
Results posted
Jun 2014
Primary outcome: Primary: Change From Baseline in HbA1c After 12 Weeks of Treatment. — 0.30; -0.42; -0.40; -0.65 percentage of HbA1c — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (low dose) (Drug); Placebo (mid dose) (Drug); Placebo (high dose) (Drug); BI 10773 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c After 12 Weeks of Treatment. |
0.30; -0.42; -0.40; -0.65; -0.61 | <0.0001 sig |
| SECONDARY Occurrence of Treat to Target Efficacy Response |
2.8; 26.2; 19.0; 32.1; 32.7 | <0.0001 sig |
| SECONDARY Change From Baseline in FPG |
4.06; -22.65; -25.28; -33.70; -32.54 | <0.0001 sig |
Summary
This study is conducted to determine the most appropriate therapeutic doses of BI 10773 in Japanese patients with T2DM at first treatment period. The second treatment period is required to obtain sufficient safety data (one-year exposure to BI 10773) in Japanese patients with T2DM according to the ICH E1 guideline.
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:
- drug-naïve, defined as no antidiabetic drugs for 10 weeks prior to informed consent.
- pre-treated with one oral antidiabetic drug; the present antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent.
- HbA1c at Visit 1a:
- for patients who are drug naïve: HbA1c >=7.0 to = =6.5 to = =7.0% and = 240 mg/dL (>13.3 mmol/L) after an overnight fast during wash-out/placebo run-in period and confirmed by a second measurement (not on the same day).
- Acute coronary syndromes, stroke or transient ischaemic attack within 12 weeks prior to informed consent
- Impaired renal function, defined as calculated eGFR <60 ml/min (MDRD formula) during screening and/or wash-out period and/or run-in phase.
- Bariatric surgery within the past 2 years and other gastrointestinal surgeries that induce chronic malabsorption
- Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
- Treatment with anti-obesity drugs (e.g. sibutramine, mazindol) 12 weeks prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body weight
Data sourced from ClinicalTrials.gov (NCT01193218). 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.