Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) Patients

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: AZD1656; Drug: Warfarin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01103609

D1020C00027

Details and patient eligibility

About

The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics and Pharmacodynamics of Warfarin in T2DM patients.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of T2DM treated with at least 1000 mg metformin as a single treatment or in combination with one other oral anti-diabetics for at least 2 months prior to screening. Doses of anti-diabetic treatment stable for at least 1 month
• Fasting plasma glucose (FPG) at screening in the range of 6.0 to 15.0 mmol/L (108 to 270 mg/dL) and FPG in the range of 7.5 to 13.0 mmol/L (135 to 234 mg/dL) on Day 1
• Haemoglobin (Hb) A1c >6.5% at screening

Exclusion criteria

• Use of drugs with anticoagulant effects 3 weeks prior to first warfarin dosing
• Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
• Previous treatment with warfarin on clinical indication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

twice daily on Day 1 to Day 10, with Warfarin on Day 4

Treatment:

Drug: AZD1656

Drug: Warfarin

2

Placebo Comparator group

Description:

twice daily on Day 1 to Day 10, with Warfarin on Day 4

Treatment:

Drug: Warfarin

Drug: Placebo