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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095991
• Other study ID #: D1020C00032
• Status: Completed
• Phase: Phase 1
• First received: March 29, 2010
• Last updated: June 30, 2010
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• AZD1656
Oral tablet bd,
• Sitagliptin
Oral tablet od

Locations

Country	Name	City	State
Germany	Research Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No