Typr 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Code: BI10773
Pharmaceutical Form: Tablet
Current Sponsor code: BI 10773
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the pla
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug other than those described in the Exclusion Criteria (antidiabetic therapy has to be unchanged for at least 10 weeks prior to screening); 2. Stable metformin therapy: a. a dose of =1500 mg/day metformin; b. in patients with a total daily dose of less than 1500 mg metformin, inclusion will only be possible if the investigator has documented them to be on their maximum tolerated dose; c. therapy needs to be stable for at least 10 weeks prior to screening 3. Glycosylated hemoglobin A1 (HbA1c) at Visit 1A (Screening) a. for patients treated with metformin and one additional oral antidiabetic drug: HbA1c =6.5 to =9.0%; b. for patients treated with metformin only: HbA1c >7.0 to =10.0% 4. Glycosylated hemoglobin A1 (HbA1c) >7.0 to =10.0% at Visit 2 (Start of Run-in) 5. Age =18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Myocardial infarction, stroke or transient ischemic attack (TIA) within 6 months prior to informed consent; 2. Impaired hepatic function, defined by serum levels of either alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), or alkaline phosphatase above 3 times the upper limit of normal (ULN); 3. Renal insufficiency or impaired renal function defined by creatinine clearance <50 mL/min or serum creatinine levels men =1.5 mg/dL ; women =1.4 mg/dL at screening; 4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurological disorders (including cerebrovascular disease and polyneuropathy) that may interfere with participation in the trial; 5. Chronic or clinically relevant acute infections (e.g., human immunodeficiency virus, hepatitis); 6. Current or chronic urogenital tract infection determined by medical history 7. History of clinically relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients); 8. Treatment with any of the following anti-diabetic treatments within 3 months prior to informed consent: a. glitazones (e.g., rosiglitazone, pioglitazone), b. glucagon-like peptide (GLP-1) analogues c. insulin 9. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within 3 months prior to informed consent; 10. Current treatment with systemic steroids at the time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent; 11. Alcohol abuse within the last 3 months that would interfere with trial participation or drug abuse; 12. Treatment with an investigational drug within 2 months prior to informed consent 13. Women of child-bearing potential who: a. are nursing or pregnant, or b. 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 periodic pregnancy testing during participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on-going metformin therapy in patients with type 2 diabetes mellitus with insufficient glycemic control.;Secondary Objective: Inclusion of an open-label treatment arm with sitagliptin (Januvia™) as add-on therapy to metformin for sensitivity measurement within this patient population. Pharmacokinetics of BI 10773 will also be assessed in this study.;Primary end point(s): The primary endpoint in this study is the change of HbA1c from baseline after 12 weeks of treatment. | — |
Countries
Austria, Czech Republic, Estonia, Finland, France, Germany, Hungary, Latvia, Spain
Outcome results
None listed