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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01095991

Enrollment

Registered

2010-03-30

Start date

2010-03-31

Completion date

2010-05-31

Last updated

2010-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Sitagliptin

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.

Interventions

DRUGAZD1656

Oral tablet bd,

DRUGSitagliptin

Oral tablet od

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026