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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: AZD1656; Drug: Sitagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01095991

D1020C00032

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

1

Experimental group

Description:

AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.

Treatment:

Drug: AZD1656

Drug: Sitagliptin

2

Experimental group

Description:

Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.

Treatment:

Drug: AZD1656

Drug: Sitagliptin