Type 2 Diabetes Mellitus MedDRA version: 12.0 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus
Conditions
Interventions
Product Name: BI 10773
Product Code: BI 10773
Pharmaceutical Form: Tablet
Current Sponsor code: BI 10773
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-
Pharma
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation • Male and female patients with a diagnosis of T2DM treated with basal glargine or detemir insulin (=20 IU/day) or NPH insulin (=14 IU/day) with or without concomitant metformin and / or sulfonylurea. The insulin and oral anti-diabetic therapy has to be unchanged for at least 12 weeks prior to randomization. • HbA1c of >7.0% and =10% at Visit 1 (screening) • Suitability for trial participation according to investigator's judgment (evaluating all alternative treatment options and in consideration of the patient completing the study) • Age =18 years at Visit 1 (screening) • BMI =45 kg/m2 (Body Mass Index) at Visit 1 (screening) 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: Clinical conditions that might interfere with the subject's ability to participate in the trial include, but are not limited to, the following: • Uncontrolled hyperglycemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast or >400 mg/dl (>22.2 mmol/L) in a randomly performed measurement during placebo run-in and confirmed by a second measurement (not on the same day). • Frequent (at the discretion of the investigator) episodes of hypoglycemic events on basal insulin therapy • Myocardial infarction, stroke, or Transient Ischemic Attack (TIA) within 3 months prior to obtaining informed consent • Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase (ALP) above 3 times the upper limit of normal ULN) as determined at Visit 1 • Impaired renal function, defined as GFR <30 ml/min • The metformin or sulfonylurea that you’re taking is not being used in accordance with local prescribing information. • Any contraindications to the background basal insulin (glargine, detemir, or NPH) according to the local label • Known hypersensitivity or allergy to the investigational product BI 10773 or its excipients • Treatment with any other oral anti-diabetic medications, other than metformin and / or sulfonylurea therapy, within 3 months of obtaining informed consent • Patients with a history of having received chronic short acting insulin, a Glycogen-like peptide – 1 (GLP-1) analogue, or an Amylin agonist, within 3 months of signing informed consent • Gastric bypass surgery or any other gastrointestinal surgery that may induce mal-absorption • Treatment with anti-obesity drugs (e.g., including but not limited to sibutramine, orlistat, or rimonabant) 3 months prior to informed consent • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent • Patients with history of any cancer within last 5 years with the exception of basal cell and squamous cell skin cancer • Pre-menopausal women (last menstruation =1 year prior to informed consent) who: are nursing their infant 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 • Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation • Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., hemolytic anemia, thalassemias, sickle cell disease, hemochromatosis with routine phlebotomy treatment, malaria). An accurate HbA1c can not be established in patients with hemolysis • Participation in another trial with an investigational drug within 2 months prior to informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint in this study is the change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the observation at the randomization visit (Visit 3) prior to treatment.;Secondary Objective: • The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <7.0% after 18 and 78 weeks of treatment • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 18 and 78 weeks of treatment • Change from baseline in HbA1c after 42 and 78 weeks of treatment • The change from baseline and percent change from baseline in fasting plasma glucose (FPG) after 18, 42, and 78 weeks of treatment • Change from baseline in dose of basal insulin therapy recorded after 18 weeks of treatment (after Visit 6) • Number dose adjustments of basal insulin therapy after18 weeks of treatment (after Visit 6) • Pharmacokinetics of BI 10773;Primary end point(s): The primary endpoint in this study is the change from baseline in Glycosylated haemoglobin A1c (HbA1c) after 18 weeks of treatment. Throughout the study protocol, the term "baseline" refers to the observation at the randomization visit (Visit 3) prior to treatment. | — |
Countries
Denmark, France, Ireland, Portugal, United Kingdom
Outcome results
None listed