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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003646-16 | EudraCT Number | EudraCT |
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Assess the safety and tolerability of once daily oral doses of BI 187004 in patients with type 2 diabetes mellitus without oral antidiabetic treatment and in patients on a stable metformin background treatment over 28 days. Assess the effect on fasting plasma glucose after 28 days of treatment and to investigate the pharmacokinetics and pharmacodynamics of BI 187004.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 187004 low dose mono QD | Experimental | patient to receive one tablet containing low dose of BI 187004 or matching placebo |
|
| BI 187004 medium dose mono QD | Experimental | patient to receive one tablet containing medium dose mg of BI 187004 or matching placebo |
|
| BI 187004 high dose mono QD | Experimental | patient to receive one tablet containing high dose of BI 187004 or matching placebo |
|
| BI 187004 high dose QD add on | Experimental | patient to receive one tablet containing high dose of BI 187004 or matching placebo add on to metformin background dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | BI 187004 high dose matching placebo once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with drug- related adverse events | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting plasma glucose (FPG) after 28 days of treatment | 4 weeks |
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Inclusion criteria:
Male or postmenopausal or hysterectomised female patients with diagnosis of Type 2 Diabetes Mellitus (T2DM) before informed consent
To be eligible for Arm 1
To be eligible for Arm 2:
a. Antidiabetic treatment with metformin with an unchanged daily dose for 12 weeks prior to Informed Consent AND patient´s willingness to keep this therapy stable during the course of the trial AND HbA1c >= 7.0% and <= 9.5% at Visit 1a
Age >=18 and <=80 years for female hysterectomised and male patients at Visit 1a
Age >=55 and <=80 years for female postmenopausal (defined by the absence of menses for at least 2 years) patients at Visit 1a
Body mass index (BMI) >= 28 and <= 40 kg/m2 at Visit 1a
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1307.4.49003 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||||
| 1307.4.49002 Boehringer Ingelheim Investigational Site |
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| Placebo |
| Drug |
BI 187004 medium dose matching placebo once daily |
|
| Placebo | Drug | BI 187004 high dose matching placebo once daily add on to background metformin |
|
| BI 187004 | Drug | BI 187004 high dose once daily add on to background metformin |
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| Placebo | Drug | BI 187004 low dose matching placebo once daily |
|
| BI 187004 | Drug | BI 187004 medium dose once daily |
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| BI 187004 | Drug | BI 187004 low dose once daily |
|
| BI 187004 | Drug | BI 187004 high dose once daily |
|
| Mainz |
| Germany |
| 1307.4.49001 Boehringer Ingelheim Investigational Site | Neuss | Germany |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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