Type 2 Diabetes Mellitus MedDRA version: 18.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Code: BI 187004 CL
Pharmaceutical Form: Tablet
INN or Proposed INN: Not Yet Assigned
Current Sponsor code: BI 187004 CL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or postmenopausal or hysterectomised female patients with diagnosis of T2DM before informed consent 2. To be eligible for Arm 1 a. Oral antidiabetic mono-therapy for the last 12 weeks prior to Informed Consent AND Glycosylated haemoglobin (HbA1c) >= 6.5% and = 7.0% and = 7.0% and =18 and =55 and = 28 and =65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: 1. Treatment with a non-oral antidiabetic therapy or with more than one oral antidiabetic medication within 12 weeks prior to visit 1a. 2. Fasted plasma glucose > 240 mg/dl (>13.3 mmol/l) on two consecutive days after screening (Visit 1a) confirmed by a fasted laboratory blood glucose test until first administration of the trial drug 3. Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1a) or any other laboratory value outside the reference range and clinically relevant in the investigator judgment 4. Any known clinically relevant concomitant diseases or chronic diseases other than type 2 diabetes, hyperlipidaemia or medically treated hypertension 5. Medical history of cancer or treatment for cancer in the last five years prior to the Visit 1a. 6. History of Cushing syndrome, Addison´s disease, congenital adrenal hyperplasia or polycystic ovary syndrome 7. Treatment with systemic, inhalatory or ophthalmologic steroids within 12 weeks prior to first administration of the trial drug. 8. Treatment compliance during the run-in period is outside the per protocol range defined range, between 80%-120% treatment compliance. 9. Use of any other concomitant medication within 5 half-lives before the first administration of the trial drug except for allowed co-medication. 10. Surgery or trauma with significant blood loss (more than 500 ml) within the last 3 months prior to informed consent or blood donation (more than 100 ml) within four weeks prior to first administration of study medication or planned during the trial 11. Any other medical condition that would interfere with trial participation based on investigator´s judgement or any on-going clinical condition that would jeopardize patient´s or site personnel´s safety or study compliance based on investigator judgement. Smoking habits interfering with hospitalization. Patients not willing to abstain from alcoholic beverages during inpatient visits 12. Male patients not willing to use adequate contraception (sexual abstinence, condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake 13. Prior to Visit 3, plasma cortisol levels higher than 83 nmol/l, in the morning, after treatment with 2 mg of oral Dexamethasone (Dexamethasone suppression test). 14. Prior to Visit 3, plasma cortisol peak levels after CRH iv injection of <377 nmol/L OR ACTH peak levels after CRH iv injection of <4.4 pmol/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the current study is to investigate the safety and tolerability of a once daily oral dose of 20 mg, 80 mg or 240 mg BI 187004 as mono-therapy and 240 mg BI 187004 on a stable metformin background over 28 days in patients with type 2 diabetes mellitus.;Secondary Objective: To evaluate the change from baseline in fasting plasma glucose after 28 days of treatment with 20 mg, 80 mg or 240 mg BI 187004 as mono-therapy and 240 mg BI 187004 on a stable metformin background;Primary end point(s): 1: The number (%) of patients with drug- related adverse events ;Timepoint(s) of evaluation of this end point: 1: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment ;Timepoint(s) of evaluation of this end point: 1: 4 weeks | — |
Countries
Germany
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed