Phase 3
N=1,363
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01422876 ↗Enrolled (actual)
1,363
Serious AEs
5.4%
Results posted
Apr 2015
Primary outcome: Primary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients — -1.19; -1.08; -0.62; -0.66 % change from baseline — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- high dose FDC (Drug); BI 10773 high dose (Drug); high dose FDC placebo (Drug); low dose FDC placebo (Drug); high dose BI 10773 placebo (Drug); low dose FDC (Drug); BI 10773 low dose (Drug); linagliptin (Drug); linagliptin placebo (Drug); BI 10773 low dose placebo (Drug); low dose BI 10773 placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients |
-1.19; -1.08; -0.62; -0.66; -0.70 | <0.0001 sig |
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients |
-1.08; -1.24; -0.95; -0.83; -0.67 | 0.1785 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients |
-35.25; -32.18; -18.83; -20.84; -13.05 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients |
-29.55; -28.21; -24.24; -22.39; -5.92 | 0.1605 |
| SECONDARY Change From Baseline in Body Weight for Metformin Background Patients |
-2.99; -2.60; -3.18; -2.53; -0.69 | 0.6604 |
| SECONDARY Change From Baseline in Body Weight for Treatment Naive Patients |
-2.00; -2.74; -2.13; -2.27; -0.78 | 0.8010 |
| SECONDARY Occurrence of Treat to Target Efficacy Response for Metformin Background Patients |
61.8; 57.8; 32.6; 28.0; 36.1 | <0.0001 sig |
| SECONDARY Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients |
55.4; 62.3; 41.5; 38.8; 32.3 | 0.0224 sig |
Summary
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
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 absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
- Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)
Exclusion criteria
- Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
- Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
- Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent
Data sourced from ClinicalTrials.gov (NCT01422876). 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.