Phase 2
Completed N=406
12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT00789035 ↗Enrolled (actual)
406
Serious AEs
1.5%
Results posted
Jun 2014
Primary outcomePrimary: Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment — 0.09; -0.43; -0.48; -0.63 percentage of HbA1c — p=<0.0001
Summary
The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Glycosilated Haemoglobin A1c (HbA1c) From Baseline After 12 Weeks of Treatment |
0.09; -0.43; -0.48; -0.63; -0.75 | <0.0001 sig |
| SECONDARY Change of FPG From Baseline After 12 Weeks of Treatment |
0.79; -23.26; -28.92; -31.08; -29.96 | — |
| SECONDARY Change of HbA1c From Baseline Over Time |
-0.01; -0.27; -0.24; -0.39; -0.26; 0.04 | — |
| SECONDARY Proportion of Patients Who Achieve an HbA1c ≤7.0% After 12 Weeks of Treatment |
22.0; 33.3; 29.6; 45.1; 45.0 | — |
| SECONDARY Proportion of Patients Who Achieve an HbA1c Lowering of at Least 0.5% After 12 Weeks of Treatment |
25.6; 46.9; 59.3; 59.8; 71.3 | — |
| SECONDARY Change From Baseline to Week 12 in Fasting Plasma Insulin (FPI) |
-0.95; -0.90; -1.02; -0.90; -0.01 | — |
| SECONDARY Change in Homeostasis Model Assessment Index for Insulin Resistance (HOMA-IR) |
-0.19; -0.85; -0.83; -0.79; -0.37 | — |
| SECONDARY Change in Homeostasis Model Assessment Index for Beta Cell Function (HOMA-%B) |
-5.20; 4.22; 1.09; 2.13; 6.69 | — |
| SECONDARY Change of Body Weight After 12 Weeks of Treatment |
-0.75; -1.81; -2.33; -2.03; -1.32 | — |
| SECONDARY Trough Concentrations of Empagliflozin in Plasma |
31.6; 61.7; 117; 20.3; 51.6; 127 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients with a diagnosis of type 2 diabetes mellitus
- either treatment-naïve or on a maximum of 1 oral antidiabetic therapy on a stable dose for the10 weeks prior to screening
- HbA1c ≥6.5 to ≤9.0% and for treatment-naïve patients:HbA1c >7.0 to ≤10.0%
- HbA1c >7.0 to ≤10.0% at Visit 2 (start of run-in) for all patients
- Age between 18 and 80 years
- BMI less than 40 kg/m2
- Signed and dated informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion Criteria
- Myocardial infarction, stroke or TIA within 6 months prior to informed consent
- Impaired hepatic function
- Renal insufficiency or impaired renal function
- Disease of central nervous system, or psychiatric disorders or clinically relevant neurologic disorders that may interfere with trial participation
- Chronic or clinically relevant acute infections
- Current or chronic urogenital tract infection determined by medical history
- History of clinically relevant allergy/hypersensitivity
- Treatment with glitazones, GLP-1 analogues or insulin within 3 months prior to informed consent
- Treatment with anti obesity drugs
- Current treatment with systemic steroids
- Alcohol abuse
- Treatment with an investigational drug within 2 months prior to informed consent
- known intolerance to metformin
- Dehydration
- Unstable or acute CHF
- Acute or chronic acidosis
- Hereditary galactose intolerance
- Woman of child bearing potential who are nursing or pregnant or not practicing an acceptable method of birth control
Data sourced from ClinicalTrials.gov (NCT00789035). 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.