NCT01103622

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 5, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

April 13, 2010

Last Update Submit

January 4, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesType 2Digoxindrug-drug interaction

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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.

  • 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

  • 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

Study Arms (2)

1

EXPERIMENTAL

twice daily Day 1 to Day 7; digoxin on day 4

Drug: AZD1656Drug: Digoxin

2

PLACEBO COMPARATOR

twice daily Day 1 to Day 7; digoxin on day 4.

Drug: DigoxinDrug: Placebo

Interventions

AZD1656DRUG

Oral tablet bd, step-wise increased dosage

1
DigoxinDRUG

Oral tablet od on Day 4

Also known as: Digacin
12
PlaceboDRUG

Oral tablet bd, step-wise increased dosage

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Chula Vista, California, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

AZD1656Digoxin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Stanko Skrtic

    AstraZeneca

    STUDY DIRECTOR

  • Christoph Kapitza

    Profil Institut für Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

  • Mirjana Kujacic

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 14, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 5, 2011

Record last verified: 2011-01

Locations

US(1)