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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: AZD1656; Drug: Sitagliptin

• Registration Number: NCT01095991
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-30
• Last Update Posted: 2010-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD1656	AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.
1	Sitagliptin	AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.
2	AZD1656	Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.
2	Sitagliptin	Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇩🇪 Neuss, Germany