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
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/2/2013 |
| Start Date: | October 2012 |
| End Date: | November 2013 |
| Contact: | Boehringer Ingelheim Call Center |
| Email: | clintriage.rdg@boehringer-ingelheim.com |
| Phone: | 1-800-243-0127 |
A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
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.
Inclusion criteria:
1. confirmed diagnosis of T2DM
2. Glycated hemoglobin (HbA1c) >=7.0 and <=10/0% at Visit 1
3. Metformin therapy (at least 1500 mg/day, BID)
4. age>=18 at Visit 1
5. body mass index <=45 kg/m2
Exclusion criteria:
1. estimated creatinine clearance rate (eCCr) <60 ml/min (Cockcroft-Gault formula)
screening and/or run-in
2. a confirmed glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during
placebo run-in
We found this trial at
38
sites
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