The study will be performed in patients (age of 18 or more) with type 2 diabetes and insufficient glycaemic control despite a background therapy of metformin or metformin plus a sulfonylurea. MedDRA version: 14.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on a diet and exercise regimen who are pre-treated with immediate release metformin or immediate release metformin plus sulfonylurea (see below for minimum doses). The treatment regimen has to be unchanged for 12 weeks prior to randomisation. Minimum dose for metformin: - > or = 1500 mg/day or - maximum tolerated dose or - maximum dose according to local label Minimum dose for sulfonylurea: - > or = half of the maximal recommended dose or - maximum tolerated dose or - maximum dose according to local label 3. HbA1c of > or = 7.0% and or = 18 5. BMI =65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day). 2. Any other antidiabetic drug within 12 weeks prior to randomisation except those mentioned in inclusion criterion 2 3. Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or TIA within 3 months prior to informed consent 4. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase 5. Impaired renal function, defined as GFR<30 ml/min (severe renal impairment) during screening and/or run-in phase 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. Contraindications to metformin and/or sulfonyurea according to the local label for those patients that enter the study with the respective background therapy 9. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cell (e.g.malaria, babesiosis, haemolytic anemia). 10. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) 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 T2D 12. Pre-menopausal women (last menstruation 1 year or less 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. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, (if acceptable by local authorities) double barrier method and vasectomised partner 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. Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial 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 efficacy, safety and tolerability of BI 10773 (10 mg, 25 mg / once daily) compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with T2DM with insufficient glycaemic control. ;Primary end point(s): The primary endpoint in this study is the change from baseline in HbA1c after 24 weeks of treatment ;Secondary Objective: 1) Change from baseline in body weight after 24 weeks of treatment 2) Change from baseline in Mean Daily Glucose after 24 weeks of treatment Other exploratory efficacy endpoints: - Occurrence of treat to target efficacy response, that is an HbA1c of <7.0% after 24 weeks of treatment - Occurrence of relative efficacy response (HbA1c lowering by a least 0.5% after 24 weeks of treatment - Change from baseline in HbA1c by visit over time - Change from baseline in waist circumference after 24 weeks of treatment - Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment - Change from baseline in FPG by visit over time - Systolic and diastolic blood pressure: Change from baseline to week 24 - Composite endpoint of the following conditions at week 24: HbA1c lowering by at least 0.5% after 24 weeks of treatment; lowering of systolic blood pressure by at least 3 mm Hg and decrease in body weight by more than 2%. ;Timepoint(s) of evaluation of this end point: The HbA1c will be measured at screening Visit (week -3), Visit 3 (week 0), Visit 4 (week 6), Visit 5 (week 12), Visit 6 (week 18) and Visit 7 (week 24). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The first key secondary endpoint is the body weight (kg) change from baseline after 24 weeks. The second key secondary endpoint is the mean daily plasma glucose (MDG) change from baseline after 24 weeks of treatment. Other secondary endpoints are: Occurrence of a treat to target response, (i.e. an HbA1c under treatment of < 7.0%), occurrence of relative efficacy response (HbA1c lowering by at least 0.5%), change in HbA1c and FPG by visit over time, change in FPG from baseline after 24 weeks, change in waist from baseline after 24 weeks, change in systolic and diastolic blood pressure from baseline to week 24 and composite endpoint of the following conditions at week 24: HbA1c lowering by a least 0.5%, lowering of systolic blood pressure by at least 3 mm Hg and decrease in body weight by more than 2%. ;Timepoint(s) of evaluation of this end point: Body weight will be measured at screening Visit (week -3), Visit 3 (week 0) and Visit 7 (week 24). Mean daily plasma glucose (MDG) wil be measured at Visit 3 (week 0) and Visit 7 (week 24). FPG will be measured at Visit 3 (week 0), Visit 4 (week 6), Visit 5 (week 12), Visit 6 (week 18) Visit 7 (week 24) and Visit 8 (week 25). Waist will measured at Visit 3 (week 0) and Visit 7 (week 24). Blood Pressure will be measured at screening Visit (week -3), Visit 3 (week 0), Visit 4 (week 6), Visit 5 (week 12), Visit 6 (week 18) Visit 7 (week 24) and Visit 8 (week 25). | — |
Countries
Canada, China, France, Germany, India, Korea, Republic of, Mexico, Slovakia, Slovenia, Taiwan, Turkey, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed