Phase 2
Completed N=100
4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
Source: ClinicalTrials.gov NCT00885118 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in Urine Glucose Excretion — 599.763; 43428.245; 81564.440; 89189.527 mg — p=<0.0001
Summary
The objective of this trial is to evaluate the pharmacodynamics, pharmacokinetics, safety, and tolerability of once daily oral administration of BI 10773 administered for 28 days in Japanese patients with T2DM.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Urine Glucose Excretion |
599.763; 43428.245; 81564.440; 89189.527; 86220.111 | <0.0001 sig |
| PRIMARY Change From Baseline in Fasting Plasma Glucose |
-15.436; -28.116; -35.355; -41.643; -42.670 | 0.0030 sig |
| PRIMARY Change From Baseline in 8-point Glucose |
-17.381; -35.263; -39.867; -43.646; -45.721 | 0.0030 sig |
| SECONDARY Change From Baseline in HbA1c |
-0.420; -0.659; -0.717; -0.849; -0.815 | 0.0705 |
| SECONDARY Change From Baseline in Fructosamine |
-8.436; 4.091; -2.453; -26.294; -28.275 | 0.4823 |
| SECONDARY Change From Baseline in 1,5-anhydroglucitol |
1.174; -3.018; -3.435; -2.863; -3.713 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Insulin |
-0.387; -0.866; -0.766; -1.730; -1.643 | 0.2498 |
| SECONDARY Change From Baseline in the Area Under the Curve of Plasma Glucose Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test) |
-81.357; -176.771; -190.837; -212.693; -217.698 | <0.0001 sig |
| SECONDARY Change From Baseline in the Area Under the Curve of Glucagon Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test) |
-23.452; -0.785; 7.124; -17.478; -12.437 | 0.0883 |
| SECONDARY Change From Baseline in the Area Under the Curve of Insulin Levels Until 4 Hours After Intake of a Standardised Food (Meal Tolerance Test) |
2.948; -5.921; -11.396; -12.695; -7.170 | 0.0318 sig |
| SECONDARY AUCτ,1 |
216; 938; 2040; 5190 | — |
| SECONDARY AUC0-tz |
216; 937; 2040; 5180 | — |
| SECONDARY AUC0-∞ |
249; 1070; 2320; 5930 | — |
| SECONDARY Cmax |
38.5; 166; 358; 844 | — |
| SECONDARY t1/2 |
9.55; 9.09; 9.14; 9.26 | — |
| SECONDARY CL/F |
149; 173; 159; 156 | — |
| SECONDARY Vz/F |
123; 136; 126; 125 | — |
| SECONDARY Ae0-24 |
338; 1640; 3460; 8550 | — |
| SECONDARY fe0-24 |
15.2; 14.8; 15.6; 15.4 | — |
| SECONDARY CLR,0-24 |
25.7; 28.7; 28.3; 27.5 | — |
| SECONDARY AUCτ,ss |
277; 1270; 2580; 6330 | — |
| SECONDARY Cmax,ss |
41.4; 182; 393; 836 | — |
| SECONDARY t1/2,ss |
12.2; 11.9; 13.4; 16.4 | — |
| SECONDARY CL/F,ss |
133; 146; 143; 146 | — |
| SECONDARY Vz/F,ss |
141; 151; 166; 208 | — |
| SECONDARY RA,Cmax |
1.08; 1.07; 1.16; 0.998 | — |
| SECONDARY RA,AUC |
1.28; 1.32; 1.32; 1.23 | — |
| SECONDARY Ae0-24,ss |
479; 2250; 4780; 11500 | — |
| SECONDARY fe0-24,ss |
21.6; 20.3; 21.6; 20.8 | — |
| SECONDARY CLR,ss |
28.8; 29.6; 30.9; 30.3 | — |
Eligibility Criteria
Inclusion criteria
- Japanese male or female patients with T2DM treated with diet and exercise alone or with one hypoglycaemic drug other than glitazones.
- Hemoglobin A1c (HbA1c) at screening (Visit 1)
- For patients treated with 1 other oral antidiabetic drug: HbA1c between 6.5% and 9.0%.
- For patients not treated with any antidiabetic drug: HbA1c between 7.0% and 10.0%.
- Age between 20 and 70 years
- Body mass index (BMI) between18.0 and 40.0 kg/m2
- Signed and dated written informed consent before admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation.
Exclusion criteria
- Antidiabetic treatment with insulin or glitazones within 3 months before obtaining informed consent or with more than 1 oral hypoglycaemic agent at the time of informed consent
- Fasted blood glucose of >240 mg/dL (>13.3 mmol/L) or a randomly determined blood glucose level of >400 mg/dL (22.2 mmol/L) on 2 consecutive days during wash-out period.
- Myocardial infarction, stroke, or transient ischaemic attack within 6 months before informed consent.
- Clinically relevant concomitant diseases other than T2DM, hyperlipidaemia, and medically treated hypertension before the first administration such as
- Renal insufficiency (calculated estimated glomerular filtration rate 160/95 mmHg,
- Neurological disorders (such as epilepsy) or psychiatric disorders
- Acute or clinically relevant chronic infections (e.g., human immunodeficiency virus, hepatitis, repeated urogenital infections)
- Any gastrointestinal, hepatic, respiratory, endocrine, or immunological disorder
- Patients under treatment with any concomitant medication except for the following drugs at the time of informed consent.:
- Statins.
- Antihypertensives (diuretics not allowed)
- alpha-Blockers for benign prostate hypertrophy
- Occasional use of acetylsalicylic acid, ibuprofen, or paracetamol
- Additional inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT00885118). 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.