Type 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: 5.0-
Pharmaceutical form of the pla
Sponsors
Boehringer ingelheim Pharma GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients with a diagnosis of type 2 diabetes mellitus, who are drug naïve (10 week oral antidiabetic drugs, 3 months glitazones, GLP-1 analogues, insulin, or never on a drug for diabetes prior to informed consent) or treated with one 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.Glycosylated hemoglobin A1 (HbA1c) at Visit 1A (Screening) a.for patients treated with one oral antidiabetic drug: HbA1c =6.5 to =9.0%; b.for patients who are drug naïve: HbA1c >7.0 to =10.0% 3.Glycosylated hemoglobin A1 (HbA1c) >7.0 to =10.0% at Visit 2 (Start of Run-in) 4.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) as determined at screening; 3. Renal insufficiency or impaired renal function defined by creatinine clearance (calculated, Cockroft Gault) a) 240 mg/dl ((>13.3 mmol/L) or a randomly determined blood sugar level above 400 mg/dl 20. Significant diabetic late stage complications (e. g. presence of cardiovascular disease with recurrent angina, proliferative retinopathy, severe polyneuropathy, gastroparesis, repeated diabetic foot lesions, nephropathy with macro-albuminuria). No formal screening will be performed but detailed medical history will be obtained including late stage complications of diabetes; medical examination must not be older than 3 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of three doses of BI 10773 compared to placebo given for 12 weeks in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement within this patient population. Pharmacokinetics of BI 10773 will also be assessed in this study. ;Secondary Objective: ;Primary end point(s): The primary endpoint in this study is the change of HbA1c from baseline after 12 weeks of treatment. | — |
Countries
Estonia, Germany, Italy, Lithuania, Sweden
Outcome results
None listed