Diabetes type 2 MedDRA version: 9.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes)
Conditions
Interventions
Product Name: BI10773
Product Code: BI10773
Pharmaceutical Form: Tablet
Current Sponsor code: BI 10773
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-
Product
Sponsors
Boehringer Ingelheim GmbH&Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients completing the entire treatment period of the preceding double-blind trial 1245.9 or 1245.10. 2. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial 1245.9 or 1245.10. 2. Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) based on the last available lab result received during the preceding trial. 3. Renal insufficiency or impaired renal function defined by creatinine clearance <50 mL/min (calculated) or serum creatinine levels in men = 1.5 mg/dL; in women =1.4 mg/dL based on the last available lab result received during the preceding trial. 4. For Patients on Metformin therapy: additional contraindications to Metformin which started during trial participation in 1245.10 or 1245.9. 5. Pre-menopausal women (last menstruation less than 1 year prior to signing informed consent) who: are nursing or pregnant or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. 6. Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation. 7. Drug abuse that in the opinion of the investigator would interfere with trial participation. 8. Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current study is to investigate the safety of BI 10773 10 mg and 25 mg once daily compared to Metformin 1000-2000 mg/day or to Sitagliptin 100 mg once daily given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus. ;Secondary Objective: An additional objective is to assess the efficacy of BI 10773 alone or as concomitant administration with Metformin in the treatment of diabetes mellitus type 2 compared to Metformin 1000-2000 mg/day or to Sitagliptin 100 mg once daily given for 78 weeks in different modalities of treatment.;Primary end point(s): There is no primary efficacy endpoint in a statistical sense in this study. Safety and tolerability will be assessed in a descriptive analysis based on: Frequency of adverse events, Frequency of hypoglycaemic events, Changes in vital signs, Use of rescue therapy, Change body weight to week 78, Change in waist circumference to week 78, Changes in lipid parameters to week 78, Frequency of clinically significant changes from baseline in clinical laboratory. Secondary endpoints with regards to efficacy are the following: Change in HbA1c after 78 weeks of treatment and over time, Occurrence of a treat to target response, defined as an HbA1c after 78 weeks of =0.5% after 78 weeks of treatment, Change from baseline in FPG after 78 weeks of treatment and over time. | — |
Countries
Austria, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Spain, Sweden
Outcome results
None listed