Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Open, Phase I Study in Patients With Type 2 Diabetes Mellitus Treated With Metformin to Evaluate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin and Vice Versa

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: AZD1656
* Drug: Sitagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with confirmed type 2 diabetes mellitus for at least 2 months and treated with metformin. Body mass index between ≥19 and ≤42 kg/m2. Exclusion Criteria: Intake of another investigational drug within the last 30 days prior to enrolment. Clinically significant illness or clinically relevant trauma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15. | Drug: AZD1656<br>* Oral tablet bd,<br>Drug: Sitagliptin<br>* Oral tablet od<br>* Other names: Januvia;|
| Experimental: 2<br>Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15. | Drug: AZD1656<br>* Oral tablet bd,<br>Drug: Sitagliptin<br>* Oral tablet od<br>* Other names: Januvia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Sitagliptin