Type 2 diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of T2DM prior to informed consent. 2. Male and female patients on diet and exercise regimen who are pre-treated with multiple daily injections (MDI) of insulin alone or in combination with immediate or extended release metformin. Any type of basal and any type of prandial insulin are allowed. Pre-mixed insulin preparations are not allowed. 3. Total insulin dose has to be > 60 IU/day at Visit 1 (screening) and should not be changed within 12 weeks prior to randomization by more than 10% daily on average from the baseline value at randomization (Visit 3). 4. Stable metformin therapy: • daily dose= 1500 mg/day or maximum tolerated dose (must be documented) or maximum dose according to the local label • The metformin dose has to be unchanged for 12 weeks before the randomization (Visit 3). 5. HbA1c = 7.5% and = 10% at Visit 1 (screening) 6. Age =18 and = 80 years at Visit 1 (screening) 7. Body mass index (BMI) =30 and = 45 kg/m2 at Visit 1 (Screening) 8. 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. Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by second measurement (not on the same day). 2. Any other antidiabetic drug within 12 weeks prior to randomization except those mentioned in inclusion criterion 2 3. Acute coronary syndrome including myocardial infarction, stroke or TIA within 3 months prior to informed consent 4. Indication of liver disease, defined by ALT, AST, or alkaline phosphatase above 3 times upper limit of normal as determined during screening or run-in period. 5. Impaired renal function, defined as GFR <60 ml/min (MDRD formula) as determined during screening and/or run-in period 6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 8. Known blood dyscrasias or any disorders causing hemolysis or unstable red blood cell (e.g. malaria, babesiosis, hemolytic anemia) 9. Any contraindications to metformin according to the local label for those patients who entered the study with metformin therapy 10. Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening leading to unstable body weight 11. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM 12. Pre-menopausal women (last menstruation <=1 year prior to 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. 13. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake 14. Participation in another trial with an investigational drug within 30 days prior to informed consent 15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the current study is to investigate the safety and efficacy of the BI 10773 treatment with two doses (10 mg q.d. and 25 q.d.) versus placebo given for 12 and 52 weeks as add-on therapy to insulin alone or in combination with metformin in patients with T2DM with insufficient glycemic control. ;Secondary Objective: Not applicable.;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 18 weeks of treatment. | — |
Countries
Belgium, Bulgaria, Finland, Germany, Spain
Outcome results
None listed