Phase 1
Completed N=78
4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00558571 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Number of Subjects With Drug Related Adverse Events — 7; 3; 4; 14 participants
Summary
Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Drug Related Adverse Events |
7; 3; 4; 14 | — |
| PRIMARY Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG |
0; 0; 1; 2; 0; 1 | — |
| SECONDARY Cmax of Empagliflozin |
309; 722; 2630; 259; 687; 2390 | — |
| SECONDARY Tmax of Empagliflozin |
1.50; 1.50; 1.50; 1.50; 1.50; 1.50 | — |
| SECONDARY t1/2 of Empagliflozin |
8.69; 8.16; 8.53; 12.20; 12.70; 15.00 | — |
| SECONDARY AUC0-∞ of Empagliflozin |
1740; 4340; 18000; 1870; 4740; 18700 | — |
| SECONDARY CL/F of Empaglifozin |
218; 223; 215; 202; 203; 208 | — |
| SECONDARY fe0-24 of Empagliflozin |
12.5; 13.3; 13.7; 18.3; 17.8; 17.5 | — |
| SECONDARY LI (Linearity Index). |
1.09; 1.1; 1.04 | — |
| SECONDARY Ae0-24 of Glucose |
4270; 7760; 5340; 6050; 6490; 8450 | — |
| SECONDARY Fasting Plasma Glucose (FPG) |
153.87; 186.18; 167.49; 149.92; -4.08; -43.7 | — |
| SECONDARY Mean Daily Glucose (MDG) Measured in Blood |
152.06; 164.83; 166.26; 149.43; 2.13; -14.69 | — |
| SECONDARY Insulin AUEC0-5 |
108.16; 117.34; 102.44; 121.53; 24.37; 3.24 | — |
| SECONDARY Insulin Emax (Maximum Measured Effect) |
50.78; 48.09; 46.13; 53.06; 7.77; 0.55 | — |
| SECONDARY Fasting Insulin |
10; 11.43; 8.74; 9.3; -1.08; -1.56 | — |
| SECONDARY Glucagon Emax (Maximum Measured Effect) |
80.35; 90.58; 82.75; 86.98; 12.44; 13.69 | — |
| SECONDARY Glucagon AUEC0-5 |
290.66; 310.76; 291.09; 303.06; 9.01; 59.69 | — |
| SECONDARY Fructosamine |
237.27; 251.88; 257.88; 237.07; 19.57; 24.75 | — |
| SECONDARY HbA1c |
6.89; 7.15; 7.45; 7.1; -0.18; -0.27 | — |
Eligibility Criteria
Inclusion Criteria
- Male and postmenopausal or hysterectomised female patients with type 2 diabetes
- Age >18 and 18.5 and 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
- HbA1c > 8.5 %
Data sourced from ClinicalTrials.gov (NCT00558571). 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.