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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Open-label, Randomised, Placebo Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics of Digoxin During Co-administration With AZD1656

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103622
• Other study ID #: D1020C00031
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2010
• Last updated: January 4, 2011
• Start date: June 2010
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: The Bavarian State Ministry of the Environment and Public Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.

• Body mass index between =19 and =42 kg/m2.

• Haemoglobin (Hb) A1c =6.5% and =9.5% at enrolment.

Exclusion Criteria:

• History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.

• Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening

• Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors

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, step-wise increased dosage
• Digoxin
Oral tablet od on Day 4
• Placebo
Oral tablet bd, step-wise increased dosage

Locations

Country	Name	City	State
United States	Research Site	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin		Serial PK blood samples will be taken on days 4-8 during the treatment periods	No
Secondary	evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.		Safety assessments will be monitored throughout the study, from screening visit until follow up visit.	No
Secondary	describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).		Serial PK blood samples will be taken on days 4-8 during the treatment periods	No
Secondary	describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.		Serial PK blood samples will be taken on days 4-8 during the treatment periods	No