Phase 2
Completed N=983
A 16 Weeks Study on Efficacy and Safety of Two Doses of Empagliflozin (BI 10773) (Once Daily Versus Twice Daily) in Patients With Type 2 Diabetes Mellitus and Preexisting Metformin Therapy
Source: ClinicalTrials.gov NCT01649297 ↗Enrolled (actual)
983
Serious AEs
2.0%
Results posted
Jul 2015
Primary outcomePrimary: HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 — -0.83; -0.72; -0.66; -0.64 percentage of HbA1c — p=<0.0001
Summary
The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16 |
-0.83; -0.72; -0.66; -0.64; -0.22 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline at Week 16 |
-27.7; -22.7; -21.2; -17.6; -0.2 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- confirmed diagnosis of T2DM
- Glycated hemoglobin (HbA1c) >=7.0 and =18 at Visit 1
- body mass index 240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in
Data sourced from ClinicalTrials.gov (NCT01649297). 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.