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The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15. |
|
| 2 | Experimental | Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Oral tablet bd, |
| |
| Sitagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of AUC0-24 and Cmax | Serial PK sampling will be done on Days 5, 10 and 15 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of tmax, t1/2 and CL/F | Serial PK sampling will be done on Days 5, 10 and 15 | |
| To evaluate the PK of the AZD1656 and its metabolite when AZD1656 is administered with and without sitagliptin by assessment of AUC0-24, Cmax, tmax and t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanko Skrtic | AstraZeneca Molndal Sweden | Study Director |
| Christoph Kapitza | Profil Institut für Stoffwechselforschung GmbH | Principal Investigator |
| Mirjana Kujacic | AstraZeneca Molndal Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Neuss | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C576407 | AZD1656 |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Oral tablet od |
|
|
| Serial PK sampling will be done on Days 5, 10 and 15 |
| To evaluate the safety of AZD1656 with and without sitagliptin by assessment of adverse events (AEs), physical examination, electrocardiogram (ECG), pulse, blood pressure (BP), weight and FPG. | Paper ECG (days 1,2,3,6,7,8,11,16), BP/pulse preentry, every residential day. Weight, physical examination preentry and follow-up. FPG on preentry, day 1,6 and 11. |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |