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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003799-63 | EudraCT Number |
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The purpose of the study is to analyse skin blood flow in diabetic patients. The patients receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397. The analysis of safety and tolerability are secondary objectives of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY1193397/Placebo (sequence A-B-C) | Experimental | Subjects with type II diabetes who follow treatment sequence A-B-C. Single oral dose of a placebo tablet in the first intervention period (Treatment A); followed by single oral dose of 1 mg BAY1193397 (Treatment B); then single oral dose of 5 mg BAY1193397 IR tablet under fasted state in the third intervention period (Treatment C). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment. |
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| BAY1193397/Placebo (sequence B-C-A) | Experimental | Subjects with type II diabetes who follow treatment sequence B-C-A. Single oral dose of 1 mg BAY1193397 in the first intervention period (Treatment B); followed by single oral dose of 5 mg BAY1193397 IR tablet under fasted state in the second intervention period (Treatment C), then single oral dose of a placebo tablet under fasted conditions in the third intervention period (Treatment A). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment. |
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| BAY1193397/Placebo (sequence B-A-C) | Experimental | Subjects with type II diabetes who follow treatment sequence B-A-C. Single oral dose of 1 mg BAY1193397 in the first intervention period (Treatment B); followed by single oral dose of a placebo tablet in the second intervention period (Treatment A), then 5 mg BAY1193397 IR tablet under fasted conditions in the third intervention period (Treatment C). A wash-out phase of approximately 120 - 360 hours was maintained between each treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1193397 | Drug | Single dose of 1 mg BAY1193397 given in the fasted state |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in resting capillary blood flow velocity (CBV) | = resting CBV after study drug administration - resting CBV before study drug administration | Before and after treatment with study drug (within 1-3 hours after treatment with study drug) |
| Change in peak CBV during reactive hyperemia | = peak CBV after study drug administration - peak CBV before study drug administration | Before and after treatment with study drug (within 1-3 hours after treatment with study drug) |
| Change in time to peak CBV during reactive hyperemia | = time to peak CBV after study drug administration - time to peak CBV before study drug administration | Before and after treatment with study drug (within 1-3 hours after treatment with study drug) |
| Change in transcutaneous oxygen pressure (TcPO2) | = TcPO2 after study drug administration - TcPO2 before study drug administration | Before and after treatment with study drug (within 1-3 hours after treatment with study drug) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-emergent adverse events (TEAEs) | From first application of study medication up to 2 days after end of treatment with study medication | |
| Number of subjects with TEAEs in different severity | From first application of study medication up to 2 days after end of treatment with study medication |
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Inclusion Criteria:
The informed consent must be signed before any study specific tests or procedures are done (patient must be able to give informed consent, no legal representative allowed)
Patients with a diagnosis of type II diabetes mellitus and PAD (peripheral artery disease) and/or microangiopathy as evidenced by at least one of the following criteria:
Age 55 to 75 years (inclusive) at the screening visit
Non-smokers are preferred for inclusion in this study. If smokers are included, they must refrain from smoking on the days of treatment periods 1, 2, and 3 until all examinations have been performed
Patients are expected to be on stable medication during study conduct. No planned changes in drug therapy during active treatment period of the study (i.e. from treatment period 1 to treatment period 3) is allowed.
Men or confirmed postmenopausal women (defined as exhibiting spontaneous amenorrhea for at least 12 months before screening or as exhibiting spontaneous amenorrhea for 6 months before screening with documented serum follicle-stimulating hormone [FSH] levels > 40 mIU/mL) or women without childbearing potential based on surgical treatment 6 weeks before screening such as bilateral tubal ligation, bilateral oophorectomy with or without hysterectomy (documented by medical report verification). Male patients, who are sexually active and have not been surgically sterilized must agree to use two reliable and acceptable methods of contraception simultaneously (one method used by the study patient and one method used by the partner) during the study and for 12 weeks after receiving the investigational medicinal product and not to act as sperm donor for 12 weeks after dosing. Acceptable methods of contraception include for example: a) condoms (male or female) with or without a spermicidal agent b) diaphragm or cervical cap with spermicide c) intrauterine device d) hormone-based contraception
Ability to understand and follow study related instructions
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Devon & Exeter Hospital | Exeter | Devon | EX2 5AX | United Kingdom |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| BAY1193397 | Drug | Single dose of 5 mg BAY1193397 given in the fasted state |
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| Placebo | Drug | Single dose of placebo given in the fasted state |
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |