Phase 3
Completed N=825
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01370005 ↗Enrolled (actual)
825
Serious AEs
1.7%
Results posted
Jun 2014
Primary outcomePrimary: HbA1c Change From Baseline — 0.03; -0.59; -0.63 percentage of HbA1c — p=<0.0001
Summary
This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Change From Baseline |
0.03; -0.59; -0.63 | <0.0001 sig |
| PRIMARY Mean 24-hour Systolic Blood Pressure Change From Baseline |
0.42; -2.99; -3.59 | <0.0001 sig |
| SECONDARY Mean 24-hour Diastolic Blood Pressure Change From Baseline |
0.30; -1.10; -1.32 | 0.0008 sig |
| SECONDARY Proportion of Patients With HbA1c <7% |
18; 79; 79 | <0.0001 sig |
| SECONDARY Fasting Plasma Glucose (FPG) Change From Baseline |
7.19; -15.23; -24.45 | <0.0001 sig |
| SECONDARY Body Weight Change From Baseline |
-0.19; -1.67; -2.16 | <0.0001 sig |
| SECONDARY Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline |
0.38; -3.40; -4.12 | <0.0001 sig |
| SECONDARY Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline |
0.26; -1.28; -1.58 | 0.0004 sig |
| SECONDARY Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline |
0.51; -2.22; -2.47 | 0.0021 sig |
| SECONDARY Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline |
0.36; -0.80; -0.75 | 0.0566 |
| SECONDARY Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline |
-0.57; -4.73; -5.45 | <0.0001 sig |
| SECONDARY Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline |
-1.02; -3.18; -3.01 | 0.0005 sig |
| SECONDARY Proportion of Patients Reaching Blood Pressure <130/80 mmHg |
19; 45; 40 | 0.0021 sig |
| SECONDARY Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight |
6; 41; 58; 265; 235; 218 | — |
| SECONDARY Orthostatic Blood Pressure |
42; 40; 51; 212; 219; 208 | — |
Eligibility Criteria
Inclusion criteria
- Patients >=18 years with type 2 diabetes
- HbA1c of >= 7.0% (53 mmol/mol) and = 240 mg/dl (>13.3 mmol/L) after an overnight fast before randomization
- Known or suspected secondary hypertension
- Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent
Data sourced from ClinicalTrials.gov (NCT01370005). 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.